Ausbruch von Vion Pharmaceut. - 500 Beiträge pro Seite

[Joe_Trader]

Kurse VION
Datum Eröffnung Hoch Tief Schluß Ø Volumen Schluß*
20-Okt-06 1,42 1,52 1,36 1,52 717.700 1,52
19-Okt-06 1,34 1,47 1,25 1,36 1.217.100 1,36
18-Okt-06 1,16 1,32 1,16 1,30 1.446.500 1,30
17-Okt-06 1,18 1,18 1,14 1,15 728.000 1,15
16-Okt-06 1,15 1,18 1,12 1,17 359.200 1,17
13-Okt-06 1,15 1,16 1,11 1,15 128.500 1,15
12-Okt-06 1,16 1,17 1,10 1,13 317.600 1,13



Fettes Kapitalpolster von circa 42 Mio US Dollar


Letzte mir bekannte News
Date presentation at the UBS Global Life Sciences Conference on Monday, September 25, 2006, at 10:30 a.m. EDT.
The conference is taking place at The Grand Hyatt Hotel in New York City and the presentation will be in Ballroom E.

The slides from the presentation will be posted to Vion's website, http://www.vionpharm.com/, at 10:30 a.m. EDT on September 25, 2006.

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is being evaluated in: (i) a Phase III trial in combination with cytarabine in relapsed acute myelogenous leukemia and (ii) a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Additional trials of Cloretazine(R) (VNP40101M) as a single agent in pediatric brain tumors, small cell lung cancer, and in combination with temozolomide in hematologic malignancies, are also underway. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating VNP40541, a hypoxia-selective compound, and hydrazone compounds. The Company also is seeking development partners for TAPET(R), its modified Salmonella vector used to deliver anticancer agents directly to tumors. For additional information on Vion and its product development programs, visit the Company's Internet web site at http://www.vionpharm.com/.

This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's ability to secure external sources of funding to continue its operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, its dependence on regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Vion's Annual Report on Form 10-K for the year ended December 31, 2005. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

COMPANY CONTACT: Vion Pharmaceuticals, Inc. Alan Kessman, Chief Executive Officer Howard B. Johnson, President&CFO [phone] phone


ÜBERSICHT

6% der Aktien im Eigentum aller Insider und 5% Eigentümer:
41% der Aktien im Eigentum von Institutionellen & Investmentfonds:



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joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.795.782 von Joe_Trader am 23.10.06 11:34:14

mal schauen was heute wieder in den USA geht.

[Planetrader]

Was war der Grund für die Rally der letzten Tage?

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.797.053 von Planetrader am 23.10.06 12:55:00

möglicherweise ein neuer Partner für ein Projekt/Versuchsreihe.
Schau mal in den Artikel den ich reingestellt habe

[Planetrader]

Die sind aber schon Wocehn alt

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.803.403 von Planetrader am 23.10.06 17:37:38

Ja aus septemper.

das volumen ist heute nicht schlecht,wenn es so weiter läuft schließen sie wieder im plus

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.805.524 von Joe_Trader am 23.10.06 19:20:56

neue analyse für vion Pharma.

-----------------------------------------------
vom 23.10.2006
http://reports.finance.yahoo.com/w0?r=28798783:1

----------------------------------------------

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.805.784 von Joe_Trader am 23.10.06 19:34:10

jemand mal mitbekommen wann erste Ausblicke der Phase 3 kommen könnten???


joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.806.851 von Joe_Trader am 23.10.06 20:23:19

ist das korrekt, fast track für phase 3 medikament?

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.806.952 von Joe_Trader am 23.10.06 20:28:14

realtime ask zur bei 1,51 $

joe

[Joe_Trader]

volumen zur Zeit circa 430 000 ,reges interesse

joe

[cyberhai]

Hier die Pipeline:



Cloretazine® (VNP40101M) is an anticancer agent in late stage of clinical development. It exhibited potent anticancer activities in preclinical studies.

Triapine®, which is designed to prevent the replication of tumor cells by blocking DNA synthesis and repair, is in Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute.

VNP40541 is an anticancer agent in late stage of preclinical development. It exhibited potent anticancer activities in preclinical studies and appears to have a unique feature unlike other available anticancer agents.

Hydrazones are anticancer compounds that have demonstrated potent antitumor effects in preclinical studies.

TAPET® is a modified Salmonella vector used to deliver anticancer agents directly to tumors .

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.808.273 von cyberhai am 23.10.06 21:43:42

korrekt,stimmt doch so mit dem Fast Track für Cloretazine® (VNP40101M)??

volumen ist erfreulich hoch und stabil .

joe

[Joe_Trader]

kann es ein das der kurs mit absicht zwischen 1,44 $ und 1,52 $ gehalten wird??

schaut euch mal das orderbuch an.

[Joe_Trader]

jetzt geht es rund realtime,mal schauen wo wir enden

joe

[cyberhai]

Antwort auf Beitrag Nr.: 24.808.443 von Joe_Trader am 23.10.06 21:51:37

Von Fast Track habe ich nichts gefunden, ist aber erst mal nachrangig, falls das Mittel erfolgreich in Phase III ist, wird sich das automatisch im Kurs ordentlich bemerkbar machen, vor allem bei der aktuell noch relativ niedrigen MK von 99.51 Mio Dollar...

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.808.758 von cyberhai am 23.10.06 22:06:19

hast du eine ahnung wann man mit ersten informationen rechnen kann?

[cyberhai]

Antwort auf Beitrag Nr.: 24.808.823 von Joe_Trader am 23.10.06 22:09:06

Nein, habe leider auch nichts gefunden...

[cyberhai]

Antwort auf Beitrag Nr.: 24.808.443 von Joe_Trader am 23.10.06 21:51:37

Haben doch Fast Track, siehe:

http://www.vionpharm.com/clinical/clinicalsummary.html

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.808.967 von cyberhai am 23.10.06 22:15:35

volumen war gut.interesse ist da ,keine eintagsfliege der kursanstieg.
hoffe es geht weiter

Volume: 469,014

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.809.063 von cyberhai am 23.10.06 22:19:40

na denn,hoffe wir mal das beste

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.809.158 von Joe_Trader am 23.10.06 22:24:36

habe mal die frage in einem us board gestellt ,was man so über die letzten tage denkt.hier die antwort.
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THe last few days have been strange. The increase in volume and price are not based on anything tangible that I can tell. My understanding is that results for Phase III would be due next year. Some have said that the lung data (phase II) should be coming out soon but I am not sure where that comes from. I hope they are right and we see something positive soon. I hope this is not some big fish puting in a short position just to push it down again over the next few days.

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weitere antwort eines anderen users

Re-review the transcript of the conference call. The first SCLC conference where data is supposed to be released will be held on 10/28/6. IMO, this is the usual pre-news buildup.
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hört gut an


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noch eine antwort

Small Cell Lung Cancer news is good and Vion is pleased to release this data on 36 patients very soon.
Results on two phase I trials and the phase II adult brain tumor trial data should be coming out before the end of the year.
I like their strategy of either selling Cloretazine themselves in the United States and partnering in the rest of the world
or by negotiating a worldwide partnership agreement with the full knowledge of the value of what they could accomplish on their own in the United States.
Bold statement.
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bin gespannt wie die aktie heute läuft.

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.810.999 von Joe_Trader am 24.10.06 04:44:20

könnte dies eine Erklärung sein.
positive ergebnisse zu der studie ?


NEWS FROM REUTERS

Vion Receives Okay From FDA to Start New Trial

CHICAGO, Feb. 10 (Reuters) - Vion Pharmaceuticals Inc. on Thursday said the U.S. Food and Drug Administration gave it the green light to start a late-stage clinical trial of cloretazine, in combination with Ara-C, in relapsed acute myelogenous leukemia.

The trial, which is expected to start in the first quarter, will be a placebo-controlled double-blind randomized evaluation of Ara-C plus cloretazine vs. Ara-C plus placebo.

The trial will include 420 patients with the disease in first relapse, with the patients having experienced a first complete remission of at least three months, but not longer than 24 months. The company estimated that it will take 30 months to recruit patients for the trial.

http://www.kpmginsiders.com/display_reuters.asp?strType=&cs_…

--------------------------------------------

mal schauen was die amerikaner sagen.

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.811.011 von Joe_Trader am 24.10.06 04:57:35

30 monate soll diese studie laufen.


schauen wir mal was wirklich der grund war für den ausbruch.


hoffe zumindest keine bärenfalle



joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.811.018 von Joe_Trader am 24.10.06 05:16:39

hält sich tapfer das baby

joe

[Joe_Trader]

morgen sollte sich vion aus dem tal weiter erheben.
handel lief heute sehr gut.Umsätze waren da,nur der widerstand sollte heute nicht bei 1,49 $ nachhaltig genommen werden.
Morgen sollte die marke fallen
morgen wird wieder über/durch vion kommuniziert.

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.855.302 von Joe_Trader am 25.10.06 22:15:01

,na geht doch + 13% vorbörslich
der Chart lügt nicht


joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.867.393 von Joe_Trader am 26.10.06 15:28:29

damit sollte der weitere Ausbruch aus dem Trendkanal erfolgt sein

Denke wir sind auf dem Weg zur 2,00 $ Marke

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.867.809 von Joe_Trader am 26.10.06 15:43:06

Druckversion
26.10.2006 13:37
Vion Pharmaceuticals Presents Initial Data From a Phase II Trial of Cloretazine(R) (VNP40101M) in Patients With Relapsed or Refractory Small Cell Lung Cancer

NEW HAVEN, Conn., Oct. 26 /PRNewswire-FirstCall/ -- Vion Pharmaceuticals, (Nachrichten) Inc. will present data today at The Fourth International Chicago Symposium on Malignancies of the Chest and Head&Neck in a poster session on its lead anticancer agent Cloretazine(R) (VNP40101M) as a single agent in a Phase II trial in patients with relapsed or refractory small cell lung cancer. The exhibits are being displayed at The Sheraton Chicago Hotel in the Chicago Ballrooms VIII, IX,&X from 7:30 a.m. to 7:30 p.m.

The Phase II trial evaluates Cloretazine(R) (VNP40101M) in two separate subpopulations of small cell lung cancer: (i) sensitive relapsed disease and (ii) refractory disease. Sensitive relapsed disease is defined as relapse after three months of first-line therapy and refractory disease is defined as relapse within three months of first-line therapy. Data are presented on a total of 36 evaluable patients: (i) 19 patients in the sensitive relapsed arm and (ii) 17 patients in the refractory arm.

Patients on the trial initially received 125 mg/m2 of Cloretazine(R) (VNP40101M) weekly for three weeks, every six weeks. This dose was later reduced by protocol amendment to 100 mg/m2 weekly for three weeks every six weeks due to significant thrombocytopenia at the initial dose level.

Of the evaluable patients on the sensitive relapsed arm, there have been 5 patients with partial response and one patient awaiting confirmation of response (overall, 32% response rate), and 2 patients have stable disease. Of those patients with refractory disease treated with Cloretazine(R) (VNP40101M), 1 patient achieved a partial response and 3 patients have demonstrated stable disease.

Grade 3 and 4 thrombocytopenia has been the most serious toxicity observed, and delayed additional treatment in several patients. Early results suggest that the reduced dose of Cloretazine(R) (VNP40101M) causes less thrombocytopenia (no grade 3 or 4 thromobocytopenia in the first four patients at this dose) but maintains disease activity.

The trial is a Simon two-stage design. Both arms of the trial met the criteria for advancement to the second stage and continue to accrue patients. If both arms complete full accrual, there will be a total of 50 patients on the sensitive relapsed arm and 37 patients on the refractory arm of the trial.

Dr. F. Anthony Greco, Director of the Sarah Cannon Research Institute in Nashville, Tennessee, commented, "Cloretazine(R) (VNP40101M) has impressive activity to date in the second-line small cell lung cancer setting. These data provide a strong rationale for further study of this drug."

Ann Cahill, Vion's Vice President of Clinical Development, said, "We are pleased that these preliminary data suggest that Cloretazine(R) (VNP40101M) is active as a single agent in a solid tumor. Small cell lung cancer accounts for up to 20% of all lung cancer cases according to the American Cancer Society. It is an aggressive cancer and at relapse has a median survival typically less than 4 months." Ms. Cahill concluded, "The data presented indicate that Cloretazine(R) (VNP40101M) warrants further investigation as a potential improvement on treatment options for patients with this life-threatening disease."

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is being evaluated in: (i) a Phase III trial in combination with cytarabine in relapsed acute myelogenous leukemia and (ii) a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Additional trials of Cloretazine(R) (VNP40101M) as a single agent in pediatric brain tumors, small cell lung cancer, and in combination with temozolomide in hematologic malignancies, are also underway. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating VNP40541, a hypoxia-selective compound, and hydrazone compounds. The Company also is seeking development partners for TAPET(R), its modified Salmonella vector used to deliver anticancer agents directly to tumors. For additional information on Vion and its product development programs, visit the Company's Internet web site at http://www.vionpharm.com/.

This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's ability to secure external sources of funding to continue its operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, its dependence on regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Vion's Annual Report on Form 10-K for the year ended December 31, 2005. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

COMPANY CONTACT: Vion Pharmaceuticals, Inc. Alan Kessman, Chief Executive Officer Howard B. Johnson, President&CFO [phone] phone

[Joe_Trader]

ne ne was machen de Amis??
jetzt im Minus

joe

[Joe_Trader]

Die Aktie macht mich fertig.
Was denn nun??

auf oder ab.

nochmal auf Fast Track zurückzukommen.

------------------------------------------
Auszug Bericht Datum: 27.03.2004

Für Cloretazine hat das Unternehmen kürzlich von der FDA den Fast Track-Status erhalten, der dem Präparat ein beschleunigtes Zulassungsverfahren zusichert. So kann VION PHARMA bereits Studienergebnisse bei der Gesundheitsbehörde einreichen, noch bevor abschließende Phase III-Resultate vorliegen.

http://www.boerse-inside.de/admin-servicecrew/newsletter/arc…

-------------------------------------------

wir sind in Phase 3. und im Jahre 2006

Hat man schon Studienergebnisse eingereicht bei der FDA ??

Sind sie evtl. Positiv ?

Warum hat sich die Aktie unter relativ hohen Stückzahlen etwas erholt?

Weshalb im Sommer die Insidertrades?

Ist man an der Fast Track Zulassung Zugange?


Sollte das der Fall sein ....

Hoffe mal das Beste

Und ein paar wirklich positive Meldungen.

Würde das Phase 3 Medikament nicht funzen, hätte man bestimmt jetzt nicht andere Versuche gestartet oder ???

Was meint Ihr ??


joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.880.189 von Joe_Trader am 27.10.06 05:24:14

Denke wenn Vion kommuniziert, das Sie schon
Ergebnisse der Studie der FDA zukommen lassen haben, bekommen wir einen Schub.
Wenn dann noch was positives mitgeliefert wird, na dannn festhalten

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.891.039 von Joe_Trader am 27.10.06 15:54:55

einige meinen in den USA, das man (Instis)bewußt den Kurs nicht laufen lassen.

Angeblich soll nächste Woche die 1,60-1,70 $ erreicht werden.

Schönes WE

joe

[cyberhai]

Antwort auf Beitrag Nr.: 24.898.210 von Joe_Trader am 27.10.06 20:15:06

Der Kurs kann bei dem relativ geringen Volumen sicher von Instis manipuliert werden..., dafür wird der Ausbruch hoffentlich umso heftiger...

Ebenfalls ein schönes WE

Gruß Cyberhai

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.898.436 von cyberhai am 27.10.06 20:22:31

volumen Gestern circa 1 Mio ,
Geschlossen + - 0
Denke neuer Ausgangspunkt/Unterstützungspunkt für die Aktie


Auf eine spannende neue Woche.


joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.910.270 von Joe_Trader am 28.10.06 11:24:34

Vion Pharmaceutical's Cloretazine (VNP-40101M) obtained fast track status for poor-risk AML patients aged 60-plus in October 2005. Positive results from the resulting pivotal phase II trial in elderly AML may mean that Cloretazine will enter the market three to nine months earlier than would have been expected, based on the ongoing phase III trial examining Cloretazine in relapsed AML...

babelfish übersetzung

Vion pharmazeutisches Cloretazine (VNP-40101M) erreichte schnellen Schiene Status für Schlechtgefahr AML Patienten gealtertes 60-plus im Oktober 2005. Positive Resultate vom resultierenden Angelphase II Versuch in älterem AML können bedeuten, daß Cloretazine den Markt drei bis neun Monate früher als einträgt, würden erwartet worden sein, gegründet auf der fortwährenden Phase III überprüfendes Probecloretazine in zurückgefallenem AML...

quelle
http://www.pharmaceutical-business-review.com/article_featur…

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 24.994.136 von Joe_Trader am 29.10.06 19:50:17

Press Release Source: Vion Pharmaceuticals, Inc.

Vion to Present at C.E. Unterberg, Towbin Life Sciences Conference
Monday October 30, 8:00 am ET

NEW HAVEN, Conn., Oct. 30 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION - News) announced today that it would be making a corporate presentation at the C. E. Unterberg, Towbin Life Sciences Conference on Tuesday, October 31, 2006, at 4:00 p.m. EST. The conference is taking place at The New York Palace Hotel in New York City and the presentation will be in the Kennedy II Room.

ADVERTISEMENT
The slides from the presentation will be posted to Vion's website, www.vionpharm.com, at 4:00 p.m. EST on October 31, 2006.

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine® (VNP40101M), a unique alkylating agent, is being evaluated in: (i) a Phase III trial in combination with cytarabine in relapsed acute myelogenous leukemia and (ii) a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Additional trials of Cloretazine® (VNP40101M) as a single agent in pediatric brain tumors, small cell lung cancer, and in combination with temozolomide in hematologic malignancies, are also underway. Triapine®, a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating VNP40541, a hypoxia-selective compound, and hydrazone compounds. The Company also is seeking development partners for TAPET®, its modified Salmonella vector used to deliver anticancer agents directly to tumors. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com.

This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's ability to secure external sources of funding to continue its operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, its dependence on regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Vion's Annual Report on Form 10-K for the year ended December 31, 2005. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

COMPANY CONTACT:
Vion Pharmaceuticals, Inc.
Alan Kessman, Chief Executive Officer
Howard B. Johnson, President & CFO
[phone] phone


Source: Vion Pharmaceuticals, Inc.

http://biz.yahoo.com/prnews/061030/nym120.html?.v=52
-------------------------------------------------------

Wenn da Morgen nicht ein paar neue gute News kommen

joe

[Joe_Trader]

Guten Morgen
Vion hat sehr schön geschlossen in den Staaten.

Es könnte sein das neue Details zu Cloretazine® (VNP40101M) bekannt gegeben werden.

Oder vielleicht ein neuer Partner für Tapet

joe

[Joe_Trader]

https://example.recognia.com/serve.shtml?page=news&output=em…

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.115.484 von Joe_Trader am 04.11.06 10:56:06

,mal schauen was es so gibt
-------------------------------------------------------
Vion to Present at Rodman & Renshaw and CIBC World Markets Conferences
Monday November 6, 8:00 am ET


NEW HAVEN, Conn., Nov. 6 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION - News) announced today that it would be making a corporate presentation at the Rodman & Renshaw 8th Annual Healthcare Conference on Tuesday, November 7, 2006, at 3:10 p.m. EST. The conference is taking place at The New York Palace Hotel in New York City and the presentation will be in the Kennedy II Room.
ADVERTISEMENT





The slides from the Rodman & Renshaw presentation will be posted to Vion's website, www.vionpharm.com , at 3:10 p.m. EST on November 7, 2006.

In addition, the Company will be making a corporate presentation at the CIBC World Markets 17th Annual Healthcare Conference on Wednesday, November 8, 2006, at 12:55 p.m. EST. The conference is taking place at The Waldorf-Astoria Hotel in New York City and the presentation will be in the Basildon Room.

The slides from the CIBC World Markets presentation will be posted to Vion's website, www.vionpharm.com , at 12:55 p.m. EST on November 8, 2006.

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine® (VNP40101M), a unique alkylating agent, is being evaluated in: (i) a Phase III trial in combination with cytarabine in relapsed acute myelogenous leukemia and (ii) a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Additional trials of Cloretazine® (VNP40101M) as a single agent in pediatric brain tumors, small cell lung cancer, and in combination with temozolomide in hematologic malignancies, are also underway. Triapine®, a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating VNP40541, a hypoxia-selective compound, and hydrazone compounds. The Company also is seeking development partners for TAPET®, its modified Salmonella vector used to deliver anticancer agents directly to tumors. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com .

This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's ability to secure external sources of funding to continue its operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, its dependence on regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Vion's Annual Report on Form 10-K for the year ended December 31, 2005. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.



COMPANY CONTACT: Vion Pharmaceuticals, Inc.
Alan Kessman, Chief Executive Officer
Howard B. Johnson, President & CFO
[phone] phone




--------------------------------------------------------------------------------
Source: Vion Pharmaceuticals, Inc.

------------

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.174.737 von Joe_Trader am 06.11.06 14:17:32

,yepp ein guter Start in die woche Plus 6% 175000 Volumen

joe

[cyberhai]

Antwort auf Beitrag Nr.: 25.176.485 von Joe_Trader am 06.11.06 15:48:54

Freut mich auch, noch hat Vion leider einen relativ geringen Depotanteil, das ändert sich aber mit der Zeit

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.177.638 von cyberhai am 06.11.06 16:41:52

ich denke Du meinst einen geringen Wert € zu jetzt.


Strong Buy

Der Ask in den USA gibt nicht viel her.

Sollte wirklich ein Investor einsteigen,geht es durch die Decke.

Freitag zum Börsenschluß in den USA wurde eine fetter Block von
31 000 Stück gehandelt.
Da wußte jemand schon was.
Wer weiss was sie heute rauslassen.

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.178.184 von Joe_Trader am 06.11.06 17:05:41

17th Annual Healthcare Conference
November 6-8, 2006

The CIBC World Markets 17th Annual Healthcare Conference will take place at the Waldorf-Astoria in New York City, November 6-8, 2006. This conference will present a core group of public and private companies who are pioneering the pharmaceutical, biotechnology, medical device and healthcare facility and service industries.

Over 16 successful years, the CIBC World Markets Healthcare Conference has become a highly valuable investor conference in this sector. Through featured keynote speakers and formal company presentations, you will gain insight from and access to industry leaders and policy makers.

The companies participating in this conference will address topical Ossues such as Medicare and Medicaid reform, generic drug regulation, development of new blockbuster pharmaceutical and biotechnology products, product safety and patent issues, cross-border reimportation, Food and Drug Administration policy, managed care, and a comprehensive look at the current M&A environment.

Mark your calendars now and plan to join more than 1,500 healthcare executives and investors in an opportunity to increase your knowledge of today's most dynamic healthcare companies.

This conference is by invitation only.
For more information, please contact your Institutional Sales Representative.



http://conferences.cibcwm.com/health06/

-----------------------------------------------------------------
Ob es Impulse für VION dort gibt ??

Ideal wäre eine News vor oder bei der Präsendation.
Naja,daran glaube ich aber nicht,wäre aber gut.

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.207.758 von Joe_Trader am 08.11.06 05:01:00

09.11.2006 14:16
Vion Pharmaceuticals to Host Conference Call to Discuss Third Quarter and Nine Month Financial Results

NEW HAVEN, Conn., Nov. 9 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, (Nachrichten) INC. today announced that it would hold a conference call on Monday, November 13, 2006 to discuss its third quarter and nine month financial results. The call will begin at 8:45 a.m. Eastern Time.

To participate in the conference call, please dial [phone] in the U.S. ([phone] for international callers) at least 15 minutes before the start of the call. When prompted for a passcode, please enter 73343514. An audio webcast of the call will be accessible at http://www.vionpharm.com/. Those who wish to listen to the conference call on the Web should visit the Investor Relations section of the Company's website at least 15 minutes prior to the event broadcast, and follow the instructions provided to assure that the necessary audio applications are downloaded and installed. These programs can be obtained at no charge to the user.

A replay of the call will be available two hours after the completion of the call at [phone] in the U.S. ([phone] for international callers), passcode 92352969. The replay will be available through Monday, November 27, 2006.

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is being evaluated in: (i) a Phase III trial in combination with cytarabine in relapsed acute myelogenous leukemia and (ii) a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Additional trials of Cloretazine(R) (VNP40101M) as a single agent in pediatric brain tumors, small cell lung cancer, and in combination with temozolomide in hematologic malignancies, are also underway. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating VNP40541, a hypoxia-selective compound. The Company also is seeking development partners for TAPET(R), its modified Salmonella vector used to deliver anticancer agents directly to tumors. For additional information on Vion and its product development programs, visit the Company's Internet web site at http://www.vionpharm.com/.

This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's ability to secure external sources of funding to continue its operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, its dependence on regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable results of earlier clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Vion's Annual Report on Form 10-K for the year ended December 31, 2005. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

COMPANY CONTACT: Vion Pharmaceuticals, Inc. Alan Kessman, Chief Executive Officer Howard B. Johnson, President&CFO [phone]


-----------------------------------------

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.244.722 von Joe_Trader am 09.11.06 18:30:40

Vion hat einen neuen Star Analysten Holley, Bret von
CIBC World Markets


Morgen gibt es Live per Audio die Präsendation der Zahlen.

Über diesen Link

http://biz.yahoo.com/cc/9/75319.html


Meinung im Yahoo Board.

Mögliche positive Kursentwicklung durch hervorgelaufene Abschläge der Aktie vor der Präsendation der Zahlen.Positiv wird auch der neue Analyst aufgenommen.


joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.341.607 von Joe_Trader am 12.11.06 18:29:15

Vion Ausbruch es wird rappeln im Karton

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.495.016 von Joe_Trader am 17.11.06 20:11:31

Denke der Markt wird heute nochmal so richtig ausschlagen.

Denke in den USA werden wir 1,80 $ haben.

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.541.428 von Joe_Trader am 20.11.06 09:27:23

okay okay haben halt 4 Tage länger da drüben benötigt für die 1,80 $

nun jetzt ist der Tenor da drüben, die 2,00 $ kommen.

joe

[cyberhai]

Schöne Entwicklung:



Gruß Cyberhai

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.573.369 von cyberhai am 21.11.06 20:23:06

sehe ich aus so

joe

[Joe_Trader]

Antwort auf Beitrag Nr.: 25.576.931 von Joe_Trader am 21.11.06 21:34:44

bin erstmal raus und beobachte Vion weiter.

Viel Glück weiterhin.

joe

[Ackergaul]

Ich bin hier seit etwa 2 Monaten dabei, der Kursanstieg hat mich gestern (natürlich freudig) überrascht. Ich fasse hier mal nur einiges kurz zusammen. Bitte informiert Euch auch über die Homepage Vions…

Cloretazine heißt die Trumpfkarte Vions und stechen soll diese vor allem in der akuten myeloischen Leukämie (AML). Hier laufen zwei Trials die zur Zulassung führen sollen:
- (CLI-033 and CLI-043) / Elderly De Novo Poor-Risk AML / Single Agent
- (CLI-037) / First Relapse AML / Combination with cytarabine
Beide haben Fast Track - und Orphan Drug Status (USA und EU). Kürzlich hat der CLI-043 Trial, der „älteren de Novo poor-risk Patienten“, die zweite Stufe der Phase II erreicht, in dem dass Ziel bei mind. 9/42 Patienten ein komplettes Ansprechen (CR/CRp) erreicht wurde. Nun wird dieser Trial fortgeführt bis die geplanten 85 Patienten eingeschrieben sind. Der zweite Trial, der „first relapse“ Patienten (Phase III) wird in Kürze ebenfalls eine Kernmitteilung herausgeben. Nachdem die Hälfte der Zielpatienten (210 von 420) seit dem 13.11.06 eingetragen sind, werden die Daten nun ausgewertet. Der Endpunkt dieses Trials ist ebenfalls CR/CRp. Allerdings wird es hier nicht einfach, die Vorgaben zu erfüllen: hier muss Cloretazine (mit Zugabe von ara-c) den Nachweis erbringen um 15 % ÜBER der Kontrollgruppe zu liegen (nur ara-c). Schafft Cloretazine dies, wird dies sicherlich vom Markt honoriert werden…

Ein weiterer Cloretazine Trial wurde in Small Cell Lung Cancer (SCLC) eröffnet. Die Daten sind O.K. und die nächste Phase wird zeigen, wie effektiv Cloretazine hier wirklich ist.

Zur weiteren Pipeline ist nicht viel zu sagen. Triapine wird etwas Stiefmütterlich seitens Vions behandelt. Ich wage zu bezweifeln, dass – sollte Cloretazine KOMPLETT versagen – dies ein Rettungsanker für Vion wird. Die Trials werden hier momentan von Sponsoren geführt. Dann gibt es da noch VNP40541 das voraussichtlich Potential hat, allerdings in diesem frühen Stadium auch kein Grund ist, in Vion zu investieren.

Zu der Bilanzseite ist zu sagen: Einnahmen KEINE, Ausgaben VIELE! Halt das übliche bei diesen Mini Biotechs… Geld ist aber erst mal da: 30 Mil. $ waren im Februar noch vorhanden und weitere 60 Mil. $ stehen Vion mittels private placement zur Verfügung! Der Earliest potential product launch ist für spätes Ende 1H 2008 (für CLI-043) laut Vion möglich!


Konkurrenz gibt es genug. ARA-C ist zurzeit das Mittel, dass zuerst bei AML Patienten angewendet wird. Des Weiteren sind da etwa Gemtuzumab, Daunorubicin, Idarubicin und nicht zuletzt Clorofabine (auch noch in Zulassungsphase).
Clorofabine (schaut auch mal Richtung Bioenvision) kämpft im Übrigen auch um die Zulassung bei der Erstbehandlung AML bei älteren Patienten. Ist in meinen Augen eine 50/50 Sache. Der CEO Vions hatte mal nebenbei im Conference Call erwähnt, dass sich Cloretazine (zuerst) und dann Clorofabine auch vertragen…


Auf welcher Grundlage der gestrige Kursanstieg zurückzuführen ist, ist für mich unklar – die Präsentation morgen bei Fortis wird’s mit Sicherheit wohl nicht sein. Wie auch immer, auch im AH Handel ging es weiter. Wer Interesse hat, sollte meiner Meinung nach, jetzt noch abwarten. Die Auswertungen des Data Safety Monitoring Board zur „Halbzeit“ zum CLI-037 werden wohl eher im Mai kommen. Dies wird dann spannend! Ist das cut-off Erfolgreich, werden die restlichen 210 Patienten zur Behandlung „eingesammelt“ und dann stehen die Chancen meiner Ansicht nach gar nicht schlecht…


Grüße

[Ackergaul]

Hmmmmh,

bin immer noch ratlos, was momentan Sache ist...

- Spekulation auf das bevorstehende cut-off (CLI-037)?
- Großer investor der "rein" will?

Zum cut-off: Die Daten werden vom DSMB ausgewertet. Ich bezweifle eigentlich, dass hier irgendetwas durchsickern kann. Selbst Vion ist nur zum Teil informiert, wie die Daten aussehen...


Mal schauen, was der Tag noch bringt. Ich rechne mit Rücksetzern, da dies nach purer Spekulation aussieht!


Grüße

[cyberhai]

Antwort auf Beitrag Nr.: 28.971.260 von Ackergaul am 24.04.07 14:59:49

Hallo Ackergaul,

freut mich, von Dir hier zu lesen

Das Handelsvolumen ist für diesen Wert auffällig hoch. Bin mir ziemlich sicher, dass in Kürze etwas verkündet wird, was eine große Wirkung auf den Kurs hat. Die Insider haben einige Aktien zugekauft (allerdings fast immer zu 0 Dollar...): http://finance.yahoo.com/q/it?s=VION

Kannst Du was zur Wirkungsweise von http://www.vionpharm.com/products/cloretazine.html im Verhältnis zu den Wettbewerbswirkstoffen sagen? Hebt sich Vion durch einen neuen Ansatz von der Konkurrenz ab?

Gruß Cyberhai

[Ackergaul]

Hi Cyberhai,

Du tummelst Dich auch bei vielen interessanten (und riskanten) Sachen rum...

Nur mal kurz: Vion hat in der Krebsbekämpfung nicht das Rad neu erfunden. Alkylating agents gab es schon (und gibt es noch). Mit Cloretazine (VNP40101M) versucht man den Spagat zwischen guter Wirksamkeit mit niedrigen Nebenwirkungen zu meistern. Gerade bei den älteren AML Patienten, von denen manche nicht mehr die Standardtherapie bekommen können, scheint Cloretazine gut zu wirken. Hier wird auch eine first-line Therapie angestrebt!
Wichtiger erscheint aber die second-line Behandlung Cloretazine mit cytarabine. Und aktuell warten (spekulieren) alle auf die "Halbzeit Meldung":
http://www.vionpharm.com/pdf/11.13.06.pdf

Noch zum nachblättern:
http://de.wikipedia.org/wiki/Alkylantien
Cloretazine gehört zu den Alkylantien (alkylierende Verbindungen). Diese gehören zu den Zytostatika, sie werden hauptsächlich als Medikament bei der Chemotherapie zur Behandlung von Krebs eingesetzt. Sie können Alkylgruppen in die DNA mit Erbinformationen einbauen und damit grundlegend umschreiben. Danach teilt sich die betroffene Zelle meist nicht mehr.

Funktion:
Da die Alkylantien mit zwei oder mehr funktionellen Gruppen versehen sind, können sie zwei DNA-Stränge vernetzen und dadurch verhindern, dass diese während der Zellteilung korrekt verdoppelt werden. Alkylantien können aber auch die DNA-Stränge aufbrechen und dadurch ebenfalls unbrauchbar machen. Die medikamentöse Wirkung beruht also auf einer Hemmung der DNA-Replikation. Alkylantien sind mutagen und karzinogen. Sie werden bei Lymphomen, Leukämie, Brust- und Lungenkrebs sowie bei Sarkomen noch oft eingesetzt. Besondere Bedeutung haben sie gegen bösartige Hirntumore.


Um mal um ein Überblick zu bekommen, die letzte Präsentation seitens Vion. Heute mittag wird noch eine aktuellere Version (Fortis) auf der Vion Homepage zur Verfügung gestellt.
http://www.vionpharm.com/pdf/CIBC06.pdf



Grüße

Ach ja! Dass Kurs und Volumen zuletzt hier deutlich angezogen haben, ist keine Bestätigung für gute Ergebnisse. Es gab zuletzt 6 kleinere Insider Transaktionen des Vorstandes, die aber zusammen kleiner als 0,3 Mil. $ waren...

[cyberhai]

Antwort auf Beitrag Nr.: 28.981.188 von Ackergaul am 25.04.07 07:03:37

Hi Ackergaul,

vielen Dank für Deine ausführliche und äußerst interessante Antwort. Mir war die Wirkungsweise und die Wettbewerbssituation in dieser Form nicht bewusst.

Die neue Präsentation ist da: http://www.vionpharm.com/pdf/Fortis07.pdf

Ich bin nicht ganz schlau aus dem Nebenwirkungsprofil geworden, kannst Du daraus oder aus einem anderen Indikator einen Vorteil für Vion erkennen?

Das mit dem anziehenden Kurs unter hohem Volumen ist selbstverständlich kein Indikator für positive News - habe mir schon gedacht, dass Du dazu was schreibst - wollte erst schreiben, dass es auch runtergehen kann (wie momentan...), dann hatte ich mich doch für die neutrale Version "was eine große Wirkung auf den Kurs hat" entschieden...

Bist Du noch in anderen Biotechs investiert? Wenn Du hier nicht antworten willst, kannst Du mir auch gerne eine BM schicken.

Gruß Cyberhai

[Ackergaul]

Antwort auf Beitrag Nr.: 28.994.727 von cyberhai am 25.04.07 17:28:52

Nabend,

Das "safety profil" von cloretazine sieht gut aus. Daran kann es hier eigentlich nicht scheitern. Neutropenia (zu wenig weiße Blutkörperchen) ist die häufigste Nebenwirkung. Relativ wenige Grad 3/4 Fälle. Kurz dazu (vereinfacht):
Grad 3 = Dosis muss verringert werden
Grad 4 = Stop der Behandlung
Grad 5 = Worst Case (TOD!)

Hab mir die Präsentation noch nicht angesehen, werds morgen im Laufe des Tages noch machen... Denke aber dass ich die Daten alle im großen und ganzen kenne.

Denke dass der Kurs in den nächsten Tagen noch weiter zurückgehen kann. Die "BIG News" kommen aber noch! Im Juni werden z.B. auch neue Daten auf der ASCO bzgl. SCLC veröffentlicht.


Schönen Abend noch!

[cyberhai]

Antwort auf Beitrag Nr.: 28.981.188 von Ackergaul am 25.04.07 07:03:37

Der Link auf Wikipedia ist super, hätte nicht gedacht, dass dort selbst diese speziellen Begriffe aus der Medizin erläutert werden. Bin gerade am durcharbeiten und werde da wohl in Zukunft öfters nachschauen. Es sind verschiedene Wirkstoff-Familien aufgeführt, weisst Du, zu welcher Cloretazine gehört:

* Stickstoff-Lost-Derivate

- Cyclophosphamid
- Ifosfamid
- Mafosfamid
- Trofosfamid
- Melphalan
- Chlorambucil

* Akylsulfonate

- Busulfan
- Treosulfan

* Nitrosoharnstoffe

- Carmustin, Lomustin, Nimustin, Estramustin

* Procarbazin und Dacarbazin
* Temozolomid
* Thiotepa

Das mit den Nebenwirkungen beruhigt mich, danke für die schnelle Antwort! Bei http://de.wikipedia.org/wiki/Zytostatikum sind die Stufen der Nebenwirkungen auch nochmals erläutert.

Falls Dir übrigens die Fragen "auf den Geist" gehen oder Du keine Zeit hast - kurze Info und ich lasse es

Gruß + ebenfalls einen schönen Abend bzw. bald eine gute Nacht!

Cyberhai

[cyberhai]

Hier die letzte Analyse lt. Aktiencheck:

http://www.aktiencheck.de/artikel/analysen-Ausland-1504735.h…

Der Vion-Director George Bickerstaff war vorher CFO bei Novartis, ich werte dies mal als positives Zeichen

Ackergaul Du hast recht, die Insiderkäufe sind in diesem Umfang nicht überzubewerten.

Gruß Cyberhai

[Ackergaul]

Antwort auf Beitrag Nr.: 29.003.433 von cyberhai am 25.04.07 21:38:21

Mahlzeit,

Cloretazine kannst Du bei denen nicht einorden. Zumindest nach meinem geringen Wissenstands... Leider bin ich in der Bio Branche seeeeehr fachfremd. Da wird (fast) mein Börsengeld verzockt, was ich in den anderen Sparten wieder einspielen muss. Einzuordnen ist Cloretazine unter: Sulfonyl Hydrazin

Die GII Analyse kannte ich, finde ich allerdings ein wenig schlampig. Eine Analyse auf Analysen von anderen zu stützen, halte ich für dumm. Und beim Umsatz denke ich, werden wir einiges mehr als die 127 Mil. $ einnehmen, falls CLI-043 und CLI-037 von der FDA "Freigabe" bekommen. vion hat in der Fortis Präsentation ja von $1.5 billion weltweites Marktpotential bei AML geschrieben!
Wenn Du über http://www.newratings.com/ nach Vions Kürzel suchst, erhälst Du noch andere Bewertungen. Aber Kursziele von Analysten bei Biotechs sind was für die Mülltonne!

Wenn die Cut-Off Daten im Mai oder Juni zum CLI-037 Trial kommen, wird man sehen wohin die Reise geht, ob 1 $ oder ...
Obwohl ich persönlich denke, dass der Kurs alleine schon durch den CLI-043 Trial abgesichert ist, der gute Chancen auf eine Zulassung haben sollte!


Grüße

[Ackergaul]

um noch mal auf den heftigen Kursanstieg über die 2 Dollar Marke zurückzukommen (vom Dienstag)...

Die MEDITOR GROUP LTD hatte zugeschlagen:
http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx…

Habe leider ansonsten nichts informatives zu dieser Gruppe er-googeln können. Ein Investor der von den Bermudas aus seine Geschäfte macht...

Im Y! Forum (ist zu 90% ein Nonsens-Board) gab es auch wenig neues:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…

MEDITOR hat nun folgende meldepflichtige Bestände:
(i) 4,400,900
(ii) 4,174,700
Ich gehe davon aus, dass diese Positionen aktuell komplett aufgebaut worden sind. Zumindest habe ich nichts gefunden, dass die schon vorher "drin" waren...
http://finance.yahoo.com/q/mh?s=VION


Sollte nicht überbewertet werden, ein klares Zockerinvestment dieses Fonds! Aber von nichts heraus, werden die auch nicht in Vion "Ihr" Geld einsetzen.


Grüße

[Ackergaul]

Von Mäusen und Menschen...

Mal ein paar Sachen zum CLI-037 Phase III Trial (first relapsed AML)


The combination therapy of a single dose of 10 mg/kg Cloretazine® plus five doses of 70 mg/kg Ara-A every other day, both administered intraperitoneally, significantly extended the long-term survival of BDF1 mice bearing the L1210 murine leukemia. At Day 65 post-tumor implantation, the combination therapy yielded a 90% survival rate compared to 40% for Cloretazine® alone and 0% for Ara-A alone. In the 10 mg/kg Cloretazine® plus 50 mg/kg Ara-C combination study, 100% survival was achieved by Day 68, compared to 90% for Cloretazine® monotherapy and 0% for Ara-C monotherapy. Thus, Cloretazine®, either alone or in combination with Ara-C or Ara-A, was found to significantly reduce tumors and improve survival, while limiting short-term toxicity.

--> also ara-c und Cloretazine scheinen sich gut zu ergänzen!


Auszug aus der Phase I:
Three complete responses (CRs) were observed among 25 patients receiving CLORETAZINE(TM) (VNP40101M) at dose levels 400-600 mg/m2. In the same group of 25 patients, an additional 6 patients achieved all criteria for CR except recovery of the platelet count to more than 100,000/mm3 (defined in the protocol as CRp). Overall, the rate of CR plus CRp at dose levels 400-600 mg/m2 was 36%. Two of the responses occurred in patients who had failed to respond to a different schedule of high-dose Ara-C in the most recent induction attempt. The other responses occurred in patients who were considered to have poor prognosis or had received substantial prior treatment.

--> Cloretazine wirkt auch dort wo ara-c "versagt"...


CLORETAZINE(TM) (VNP40101M) 500 mg/m2 with Ara-C 1500 mg/m2 for four days was selected as the maximum tolerated dose (MTD). The toxicity profile of the combination at the MTD was similar to that expected for a similar dose and schedule of Ara-C alone.

--> Nebenwirkungsprofil ist mit Cloratazine, annähernd gleich als ara-c alleine!


An folgenden Kriterien muss sich Cloretazine messen lassen:
Primary Outcome Measures:
- Overall response rate
Secondary Outcome Measures:
- Time to tumor progression
- Duration of response
- Overall response
- Toxicity

Um im CLI-037 Trial den nächsten Step (die nächsten 210 Patienten) zu ereichen, muss Cloretazine eine um 50 % bessere ORR zu ara-c alleine aufweisen. Wenn man jetzt die (CR und CRp) Daten aus Phase I zurückrechnet:
RR 9 / 25 (= 36 %) insgesamt. Zieht man die 2 Patienten davon ab, die auf ara-c vorher NICHT angesprochen haben, so kommt man auf (7 / 25) 28 %. Bei diesem Prozentsatz weiß man nun allerdings nicht wie Cloretazine daran "beteiligt" war.

--> also, dass cut-off zu bestehen ist möglich... Wie eng das DSMB die Auswertung sieht, also ob auch bei 40 % ein "Ja, macht mal weiter" kommt, kann ich leider nicht sagen.


Grüße

[Ackergaul]

Ein paar Sachen auf die ich warte:
- Als erstes natürlich gerade die CLI-037 Daten (first relapsed AML). Das DSMB wird wohl bis vor dem ASCO Start (Anfang Juni) die Daten preisgeben. Könnte nach Auskunft Vions aber auch noch bis Quartalsende dauern...
- Bis Ende Juni werden auch wohl alle Patienten im elderly de novo poor-risk AML (CLI-043) dann eingeschrieben sein!
- Beim ASCO Meeting (1.-5. Juni) werden neue Daten zu Cloretazine in SCLC bekannt gemacht. Das könnte auch wichtig werden (3. Hoffnungsschimmer)

Viel zu Triapine kann ich momentan nicht sagen... Habe da kein gutes Gefühl, lasse mich aber gerne eines besseren belehren! Werde mir mal in nächster Zeit einige Sachen da anschauen. Die 5 Trials (glaube ich) sind aber alle noch in Phase I oder II.

TAPET das "drug delivery system" wird wohl eingestampft. Hier sucht man schon jahrelang einen Partner.

Erst danach folgen wieder Sachen auf die ich setzte:
VNP40541 und Hydrazone - nur sind diese noch nicht mal in den klinischen Phasen...

[cyberhai]

Hallo Ackergaul,

vielen Dank für die weiteren Informationen

Falls ich was neues finde, werde ich dies hier selbstverständlich auch gleich einstellen. Respekt vor Deiner Analyse, da kann ich leider nicht mithalten

Die 2 Dollar erweisen sich noch als relativ große Hürde:

]

Gruß Cyberhai

[Ackergaul]

Antwort auf Beitrag Nr.: 29.121.052 von cyberhai am 03.05.07 21:32:19

Hallo cyberhai,

wir werden sehen, was die Anlayse nutzt...

Auf den aktuellen Kurs schaue ich eigentlich nur nebenbei. Sehen die kommenden News gut aus, dann ist die 2 $ Marke kein Thema mehr. In 4 - 5 Wochen sind wir klüger!


Grüße

[cyberhai]

Am 09.05. werden die Quartalszahlen veröffentlicht:

http://biz.yahoo.com/prnews/070504/nyf032.html?.v=81

Gruß Cyberhai

[cyberhai]

Hier die Quartalszahlen: http://biz.yahoo.com/prnews/070508/nytu181.html?.v=66

Gruß Cyberhai

[Ackergaul]

Antwort auf Beitrag Nr.: 29.222.173 von cyberhai am 08.05.07 22:30:33

Leider wie befürchtet, (IMO) eher uninteressant...

Zudem hört sich das für mich nach ein wenig Verzögerung an. Ist ja allgemein bei Biotechs ein Gesetz, dass Termine dafür da sind, um verschoben zu werden...
"Our objective remains to file a New Drug Application for Cloretazine® (VNP40101M) with the U.S Food and Drug Administration in 2008.”
Gut, es war klar dass der NDA Antrag, erst 2008 gestellt werden kann, aber Kessman hätte mit Sicherheit betont, dies im 1. Quartal zu erledigen. Ist aber nur eine Vermutung von mir - wie auch immer.

Zu den möglichen Markteinführungen Cloretazines - vom Annual Meeting 2006 war zu lesen:
Cloretazine: for use in the induction treatment of elderly (at least 60 years old) patients with de novo poor-risk AML.
--> Earliest potential product launch 1H08

Cloretazine: for use in combination with Ara-C in patients for the treatment of relapsed or refractory AML.
--> Estimated launch 2H08


Mit der Finanzierung des Unternehmens sollte erst einmal alles gesichert sein. Wenn er Mitte 2009 anspricht, geht er davon aus, das die cash-burn Rate auf Durchschnittlich etwa 10 Mil $ ansteigen könnte (auch wegen den Zulassungs-Anträgen...)!


Kessman hat sich aber ziemlich knapp gehalten und nicht angedeutet. Interessant wäre doch wann nun etwa die Daten vom DSMB veröffentlicht werden.


Zur ASCO (Anf. Juni) nochmal was. Hier werden wir folgendes sehen:
- phase I trial in children with brain tumors
- phase II trial in small cell lung cancer


Grüße

[Ackergaul]

Antwort auf Beitrag Nr.: 29.224.781 von Ackergaul am 09.05.07 09:26:47

Vion - wie gehts weiter?

Die cut-off Daten lassen auf sich warten. Mittlerweile steht auch eine Veröffentlichung der Daten erst im Juli im Raume... Was könnte das bedeuten?
Sind nur meine Spekulationen, aber wären die Daten sehr gut oder sehr schlecht, wäre der Trial bereits weitergeführt bzw. gestoppt worden. Möglicherweise ist das Ergebnis also "Interpretationsbedürftig". Ich gehe davon aus, dass das primäre Ziel der Studie, die Verbesserung der Complete response um 50 % im Vergleich zum control arm, nicht erreicht wird. In meinen Augen, aber noch kein Grund die Flinte ins Korn zu schmeissen...
Da der Termin der Veröffentlichung des DSMB immer weiter nach hinten rutscht, nehme ich an, dass die Progression-free survival noch begutachtet werden soll. Würde einiges dafür sprechen, da die EMEA beispielsweise diesen Punkt für sehr wichtig betrachtet!
Aber erst einmal kommt die ASCO und da werden dann eben die erwähnten Poster zu sehen sein:
- phase I trial in children with brain tumors
- phase II trial in small cell lung cancer

Da gibt es dann neue Impulse...


Grüße

[Ackergaul]

http://www.asco.org/

Vion

Monday, 06/04/2007
1:00 PM - 5:00 PM

Phase I trial of VNP40101M in children with recurrent brain tumors--A Pediatric Brain Tumor Consortium (PBTC) study.
Poster Number: U1 Abstract No: 2059

Presenter:
Sridharan Gururangan, MRCP

Sunday, 06/03/2007
8:00 AM - 12:00 PM

A phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases.
Poster Number: EE5 Abstract No: 7724

Presenter:
Tarek Mekhail, MD

[Ackergaul]

auch Fludara und Cloretazine scheinen sich gut zu vertragen... Die Meldung ist nichts umwerfendes, da im Vergleich zu anderen Cyclophosphamiden die gleiche Wirksamkeit erreicht werden, ABER eben geringere Nebenwirkungen auftreten!

1: Cancer Chemother Pharmacol. 2007 Jun;60(1):45-51. Epub 2007 Jan 26.
Anti-tumor efficacy of Cloretazine (VNP40101M) alone and in combination with fludarabine in murine tumor and human xenograft tumor models.Zheng LM, Li Z, Liu L, Song BL, King I.
Vion Pharmaceutical, Inc., 4 Science Park, New Haven, CT, 06511, USA, [e-mail].

Cloretazine (VNP40101M), a new sulfonylhydrazine alkylating agent, has demonstrated broad-spectrum anti-tumor activity in preclinical studies. In this study, Cloretazine was evaluated both as a monotherapy and in combination with fludarabine in murine tumor and human tumor xenograft models. Cloretazine significantly inhibited the growth of subcutaneously implanted tumors, including B16F10 murine melanoma in C57BL/6 mice, and H460 human lung carcinoma and WiDr human colon carcinoma in athymic nude CD1 mice. The inhibition of tumor growth by Cloretazine was dose dependent, increasing from 42.2 to 87% as the dose escalated from 100 to 150 mg/kg. Cloretazine showed equivalent efficacy but lower toxicity compared to cyclophosphamide in these models. The combination therapy, consisting of a single dose of 10 mg/kg Cloretazine plus five doses of 70 mg/kg fludarabine, given every other day intraperitoneally, significantly increased the long-term survival of BDF1 mice bearing the L1210 murine leukemia. On Day 65 post-tumor implantation, the combination therapy yielded a 90% survival rate compared to 40% for Cloretazine alone and 0% for fludarabine alone.

PMID: 17256135 [PubMed - in process]


Wo Cloretazine total versagt: recurrent glioblastoma. Da kann sofort die Reißleine gezogen werden!

Phase II study of Cloretazine for the treatment of adults with recurrent glioblastoma multiforme.Badruddoja MA, Penne K, Desjardins A, Reardon DA, Rich JN, Quinn JA, Sathornsumetee S, Friedman AH, Bigner DD, Herndon JE 2nd, Cahill A, Friedman HS, Vredenburgh JJ.
Duke University Medical Center, Brain Tumor Center, Department of Surgery, Durham, NC 27710, USA.

Cloretazine (VNP40101M) is a newly synthesized alkylating agent belonging to a novel class of alkylating agents called 1,2-bis(sulfonyl)hydrazines. Agents that belong to this class do not produce vinylating and chloroethylating species, and hence this class of alkylating agents is thought to have minimal systemic toxicity. Cloretazine produces two short-lived active species: 1,2-bis(methylsulfonyl)-1-(2-chloroethyl) hydrazine (a chloroethylating species) and a thiophilic carbamoylating methylisocyanate species. The chloroethylating species preferentially produces lesions at the O(6) position of guanine. The methylisocyanate species may inhibit O(6)-alkylguanine-DNA alkyltransferase, an important mechanism of resistance against alkylating agents. The purpose of this study was to determine the efficacy and tolerability of Cloretazine in patients with recurrent glioblastoma multiforme. The basis for the determination of efficacy was the proportion of patients alive without evidence of disease progression six months after initiation of treatment. Patients with recurrent glioblastoma multiforme received Cloretazine (300 mg/m(2)) intravenously every six weeks. Radiographic response, survival data, and toxicity were assessed. Thirty-two patients were enrolled. Median age was 56 years; 24 patients (75%) were men. At six months, two patients were alive and progression free, so the six-month progression-free survival (PFS) was 6%. The median PFS was 6.3 weeks. There were no objective radiographic responses. Twelve patients had stable disease for at least one cycle, but only two patients received more than three cycles. Nine patients experienced grade 4 thrombocytopenia and three patients experienced grade 4 neutropenia. Cloretazine administered every six weeks was relatively well tolerated, although this schedule has insignificant activity for patients with recurrent glioblastoma multiforme.

PMID: 17108065 [PubMed - indexed for MEDLINE]


Momentan ist alles seeehr ruhig... und vor der ASCO wird sich daran bestimmt nichts ändern.

[zenman]

servus acki, alter schufter

bin dabei

[Ackergaul]

Antwort auf Beitrag Nr.: 29.406.743 von zenman am 21.05.07 17:54:47

wir wollen doch mal hoffen, dass Vion zu uns allen gut ist...

- die ASCO sollte gute News bringen, mit Hauptaugenmerk auf SCLC
- zum "elderly de novo AML" Trial, könnte ich mir vorstellen zum Jahresende "zulassungsfähige Daten" zu sehen
- tja, und dann kommen halt noch die Daten zum "Main Trial": Cloretazine und ara-c in den nächsten 6 Wochen. Da muss man auf jeden Fall noch Daumen drücken...


einen schönen Abend noch!

[cyberhai]

Antwort auf Beitrag Nr.: 29.406.743 von zenman am 21.05.07 17:54:47

Hallo Zenman,

willkommen im Club - Du bringst uns anscheinend Glück

Vion ist heute unter den PRICE % GAINERS: http://finance.yahoo.com/gainers?e=us

Gruß Cyberhai

[zenman]

Antwort auf Beitrag Nr.: 29.422.311 von cyberhai am 22.05.07 18:07:56

andere sehen das genau anders

grüss dich hai

[cyberhai]

Antwort auf Beitrag Nr.: 29.422.612 von zenman am 22.05.07 18:26:09

Vielleicht diesmal ein Kontraindikator im für uns positiven Sinn

[Ackergaul]

gestern gab es noch eine Mitteilung im BioHealthInvestor:
http://biohealthinvestor.com/2007/05/biowatch-alert-vion-jum…
Tuesday, May 22, 2007
BioWatch Alert: Vion Jumps on Strong Volume, No News


by H.S. Ayoub
BioHealthInvestor.com



Shares of Vion Pharmaceuticals (VION) gained more than 6% on Tuesday as volume was almost five times the 3 month daily average!

There were no news or any significant events that could be detected.

Vion develops and commercializes products for the treatment of cancer, including Cloretazine, an alkylating agent that is undergoing a Phase 3 trial for the treatment of relapsed acute myelogenous leukemia (AML), and a Phase 2 trial for the treatment of de novo poor-risk AML in previously untreated elderly patients; and Triapine, a small molecule for the prevention of the replication of tumor cells.

The company has a tiny market cap of only $147 million. It has almost $80 million in cash and more than $50 million in debt according to the latest Yahoo! financial data.

Shares of Vion closed at $2.02 on Tuesday, 12% below the 52-week high of $2.30.

Vion has made BHI's BioWatch Alert List, and will be tracked for the next two weeks.



Source: BioHealthInvestor.com


Als zuletzt die Umsätze massiv gestiegen waren, war ein Investor der Rein wollte "Schuld" (MEDITOR GROUP). Möglich, dass sich dies nochmal wiederholt...

[zenman]

möglich das die trader sich für die asco news positionieren

[Ackergaul]

SUPERGAU!!!
das gibt auch wohl zwei Bier heute abend...

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn…

May 23 (Reuters) - Vion Pharmaceuticals Inc. (VION.O: Quote, Profile , Research) said it would suspend enrollment and patient treatment in a late-stage trial of its blood cancer drug on mortality concerns, sending the company's shares down more than 50 percent in pre-market trade Wednesday.

An independent panel reviewed the study data and recommended that "any advantage in complete remission could be compromised by the observed on-study mortality to date," the company said in a statement.

"There will be a thorough analysis of all the data ... we will base any decision on the continuation, possible modification or termination of the study on the available data," said Chief Executive Alan Kessman.

Editors Choice: Best pictures
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The trial evaluated the drug, Cloretazine, in patients with relapsed adult myelogenous leukemia.

The panel reviewed clinical data from the first 210 treated patients, Vion said.

Vion shares were trading at 90 cents in early electronic trade, compared with their Tuesday close of $2.02 on the Nasdaq. (Reporting by Deepti Chaudhary and Varsha Tickoo in Bangalore)

[Ackergaul]

Antwort auf Beitrag Nr.: 29.435.579 von Ackergaul am 23.05.07 15:12:44

Schlimmer gehts nimmer...

1. ich habe erwartet, dass Vion nicht die Vorgaben bezüglich ORR trifft, aber dies ist ja nicht das Problem: mortality concerns!

2. jetzt kann gerätselt werden, obs an der ara-c Kombi liegt oder woran auch immer. Im elderly de novo trial ist hier nicht aufgefallen.

3. Wäre das Problem "nur" die fehlende Signifikanz zu ORR gewesen, wärs ja nichtmal ganz so übel, aber nein... Nun wird Cloretazine (und damit auch alle laufenden Trials) natürlich kräftig abgestraft.

Mei-O-Mei

[zenman]

Antwort auf Beitrag Nr.: 29.436.240 von Ackergaul am 23.05.07 15:42:17

sags mal bitte in einfachen worten

ich hab verstanden
dass der trial angehalten wurde
weil bestimmte daten genau analysiert werden sollen
also hat es auffälligkeiten gegeben

wär es denn möglich
dass es nach der analyse wieder weitergeht
oder
befürchtest du schlimme nebenwirkungen oder so was ?

[Ackergaul]

Antwort auf Beitrag Nr.: 29.436.528 von zenman am 23.05.07 15:54:12

die "Sterblichkeitsrate" ist zu hoch!!!

Diese war stets eigentlich im gleichen Rahmen beziehungsweise niedriger als bei Andern...
Nun nach 210 Patienten kommt wohl heraus, dass Sterblichkeitsrate uns Ansprechrate "nicht mehr sich ausgleichen". Nachher gibts ne Konferenz, werde heute Abend mal schauen Infos zu bekommen...

Wenn ich dann noch nüchtern bin

[cyberhai]

Antwort auf Beitrag Nr.: 29.436.651 von Ackergaul am 23.05.07 16:00:02

Das ist der entscheidende Auszug:

The DSMB's review of clinical data from the first 210 treated patients resulted in a recommendation that enrollment and further treatment of patients on study be suspended. The DSMB's recommendation was based on their evaluation that any advantage in complete remission could be compromised by the observed on-study mortality to date.

The study will remain blinded while a complete medical review is conducted.

Ackergaul, was meinst Du, gibt es noch eine Chance

[Ackergaul]

Antwort auf Beitrag Nr.: 29.436.910 von cyberhai am 23.05.07 16:11:20

momentan würde ich sagen, das wars...

Ich werde die nächsten 4-6 Wochen zumindest nochmal dabeibleiben. Aber letztendlich stehts aktuell ziemlich mies! Gut, Cash ist erstmal genug da, aber der eigentliche Knaller in der Pipeline steht jetzt als "killer" da. Von Tripapine bin ich nicht begeistert, noch weniger von Tapet.

Zumindest will ich erstmal Aufklärung in der Studie. Wie siehts mit den Responds aus? Ist der Unterschied in der Sterblichkeit deutlichst?

Fragen über Fragen, die AdHoc niemand beantworten kann. Zumindest brennt der Baum... Muss jetzt erstmal für sportlichen Ausgleich sorgen, bevor das körperliche (in flüssiger Form) folgt!

[zenman]

bin raus zu 1,02

ein kl. vermögen verbrannt

[Ackergaul]

Antwort auf Beitrag Nr.: 29.438.413 von zenman am 23.05.07 17:17:27

war mit Sicherheit keine falsche Entscheidung...

Kurz mal das wesentliche vom 25 Minütigen Conference Call:
http://biz.yahoo.com/cc/7/81647.html
Was Vion weiß ist das sie von NICHTS wissen. Für mich bleibt die Frage warum dann ein CC? Ich hoffe ich fasse das jetzt richtig zusammen: Das DSMB (das sind die (sind Unabhängig!!!), die den Trial beobachten und einzig und alleine die kompletten Daten einsehen können) hat beschlossen den Trial anzuhalten, aufgrund besagter erhöhter Sterblichkeitsrate im Cloretazine-Arm. Vion kennt diese Daten noch nicht und ist mehr als verwundert, da bisher noch nie dieses "Problem" aufgetaucht ist.
Also man weiß von NICHTS. Die Hoffnung Vions ist, dass der Trial modifiziert und wieder gestartet wird. In meinen Augen bleibt das ein Wunsch!

Zum CLI-043 Trial: der läuft normal weiter. Ende Juli sind wohl alle Patienten rekrutiert und Ende des Jahres wird ausgewertet. Für mich bleibt die Frage: waren hier keine Auffälligkeiten?

Ich selber werde mir die nächsten 4-6 Wochen ansehen und dann entscheiden. Momentan glaube ich, dass die Kombi ara-c und Cloretazine Schuld ist und nicht Cloretazine alleine. Auf jeden Fall will ich noch diese Daten zum angehaltenen Trial (CLI-037) sehen.

Trotz allem (oder gerade deswegen) - Schönen sonnigen Donnerstag Euch!!!

[Ackergaul]

Vion Pharmaceuticals downgraded to "market perform"

Thursday, May 24, 2007 10:41:20 AM ET
Rodman & Renshaw

NEW YORK, May 24 (newratings.com) - Analysts at Rodman & Renshaw downgrade Vion Pharmaceuticals (VION.NAS) from "market outperform" to "market perform."


Ich bin seit gestern stark am Überlegen, ob ich nicht die Vorboten hätte kommen sehen müssen. Bioenvision stieg eigentlich grundlos in den letzten Tagen, die Verzögerung der Meldung des DSMB (sollte eigentlich Anfang 3. Q kommen) und vorgestern halt ein sehr hohes Volumen bei "nur" 5-6 % Kursanstieg... Iregndetwas war halt faul.

Was mich immer noch grübeln lässt, ist warum hat das DSMB solange gewartet? Wenn die "Sterblichkeitsrate" so deutlich war, hätten sie früher stoppen müssen. Warum erst beim jetzt geplanten cut-off?

Mal abwarten was noch rauskommt...

[Ackergaul]

Antwort auf Beitrag Nr.: 29.455.720 von Ackergaul am 24.05.07 18:48:07

Thursday, May 24, 2007
Vion Jumps on Heavy Volume, Then Plunges 60 Percent!


by Hisham S. Ayoub, DMD
BioHealth Investor.com



On Tuesday, shares of Vion Pharmaceuticals (VION) traded up sharply on heavy volume with no news. That night Vion was placed on the BHI BioWatch Alert list to be tracked over the next two weeks.

Surprisingly, the very next morning on Wednesday Vion sent out a press release saying that it will "suspend enrollment and further patient treatment in its Phase III clinical study of Cloretazine® (VNP40101M) for patients with relapsed adult myelogenous leukemia (AML) pending a detailed review of all of the data from the trial. This decision was based on the recommendation of the trial's independent Data Safety Monitoring Board (DSMB) after a planned interim analysis."

Shares promptly sold off in pre-market action to the tune of a 60% decline in price.

Stocks on the BHI BioWatch Alert list have generally done well, with the first five stocks averaging a high of 17% within two weeks. Only Provectus (PVCT.OB) was a loss. The purpose of the watch list is to catch stocks right before a major move, hopefully a positive move!

So here's my question; how could a stock, that traded up more than 6% on almost five times the 3-month daily average volume, and finish only 12% away from the 52-week high, come up with a devastating news release the next day and plunge more than 60%?

Whatever the answer may be, this event will reinforce the notion that investing in small biotechs for short term gains will always be a risky endeavour to say the least.



Auf die Antwort wäre ich auch gespannt...

[Ackergaul]

jetzt werde ich hier schon zum Spammer...

Fortis bleibt postiv gegenüber Vion! Überrascht mich eigentlich.


US | NASDAQ | Vion Pharmaceuticals quote - chart - all headlines - investor relations - analyst actions - add to watchlist - current ratings
NASDAQ: VION.NAS at 4.00PM ET $0.90 +0.04 (+4.65%)


Vion Pharmaceuticals "buy," target price reduced

Thursday, May 24, 2007 2:58:26 PM ET
Fortis Bank

NEW YORK, May 24 (newratings.com) - Analysts at Fortis Bank reiterate their "buy" rating on Vion Pharmaceuticals Inc (VION.NAS). The target price has been reduced from $4 to $2.25.

[Ackergaul]

http://biz.yahoo.com/e/070525/vion8-k_a.html
Form 8-K/A for VION PHARMACEUTICALS INC

--------------------------------------------------------------------------------

25-May-2007

Other Events, Financial Statements and Exhibits

Item 8.01 Other Events.
On May 23, 2007, Vion Pharmaceuticals, Inc. ("Vion") issued a press release announcing it would suspend enrollment and further patient treatment in its Phase III clinical study of Cloretazine® (VNP40101M) for patients with relapsed acute myelogenous leukemia pending a detailed review of all the data from the clinical study. This decision was based on the recommendation of the trial's independent Data Safety Monitoring Board after a planned interim analysis. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

Following the announcement Vion hosted a conference call to discuss its decision. A copy of the transcript of that teleconference is attached to this Current Report on Form 8-K as Exhibit 99.2 and is incorporated herein by reference. Subsequent to the conference call, during a teleconference with the FDA initiated by Vion regarding the suspension of the Phase III trial, the FDA informed Vion that the trial would be placed on hold. As planned, Vion will not resume the study without prior discussions with the FDA and, as appropriate, other regulatory authorities.


Item 9.01 Financial Statements and Exhibits.


Ist aus meiner Sicht, die richtige Entscheidung.
1. Erst einmal alles auf Eis legen (natürlich "NUR" im CLI-037 Trial!)
2. Wohl am Wichtigsten: Der Einblick und dann die Auswertung der bisherigen Daten.
3. Gespräche mit der FDA führen, ob oder wie Vion eventuell den Trial fortführen kann / darf.


Für mich stehen viele Fragen im Raum. Die entscheidene bezieht sich auf die Aussage des DMSB "any advantage in complete remission could be compromised by the observed on-study mortality to date," .
Hier kann wunderbar spekuliert werden... War dem DSMB die Sterblichkeitsrate im Cloretazine / ara-c Arm zu hoch im Vergleich zum ara-c Arm? Oder war vielleicht die Respond Rate nur moderat höher im Cloretazine / ara-c Arm bei ähnlicher mortality? Die größte Frage ist für mich aber - warum jetzt? Konnte dies nicht schon vorher gesehen werden?


Ich hoffe, dass die Daten recht zügig veröffentlicht werden. Terminaussagen sind noch nicht getroffen worden.

[Ackergaul]

Folgendes ist aus der Think Equity Partners LLC Präsentation:

Outcomes in AML Therapy



.............................Age (yrs).....CR rates (%)...Induction deaths (%) 



Bennett et al Cancer (1997)..<60...........70.............10

.............................61-69.........55.............20

.............................>70...........35.............39



CLI-033 de novo AML..........72 (60-84)....50.............17



• Encouraging activity

• Reasonable toxicity profile

• Acceptable induction death mortality

Hier sieht es ja GUT aus im Vergleich zur Auswertung der Standardbehandlungen! Deswegen verstehe ich das Statement des DSMB noch nicht. Gut die werden mit Sicherheit, auch noch diejenigen gemeint haben, deren Behandlung nicht angesprochen hat (disease progression).

[Ackergaul]

Nichts Weltbewegendes, aber vielleicht von Interesse:
Zum Downgrade von Rodman & Renshaw (Vion nun market perform) und anschließendem Bericht im Fool zu Rodman & Renshaw.

http://www.marketwatch.com/News/Story/Story.aspx?guid=%7bCD1…
Rodman & Renshaw cuts Vion to market perform

By Val Brickates Kennedy
Last Update: 2:40 PM ET May 24, 2007


BOSTON (MarketWatch) -- Analysts at Rodman & Renshaw on Thursday lowered their rating of Vion Pharmaceuticals (VION : Vion Pharmaceuticals Inc 0.94, +0.04, +4.4%) to market perform from market outperform, citing a recent decision to halt the company's Phase III clinical trial for its cancer drug Cloretazine due to suspected safety problems. The analysts said that concerns about the drug's safety in treating acute myelogenous leukemia, AML, may lead the FDA to request that additional safety studies to support any market application. "We are lowering our rating for Vion Pharmaceuticals from a Market Outperform rating to a Market Perform rating based on the uncertainty surrounding the clinical development plan for Cloretazine in AML, a low NPV for the Cloretazine franchise assuming a delay in the elderly AML program, and a lack of near-term drivers," the analysts added.

http://www.fool.com/investing/high-growth/2007/05/25/get-to-…

Get to Know a Guru
By Rich Smith May 25, 2007


At The Motley Fool, we poke plenty of fun at Wall Street analysts and their endless cycle of upgrades, downgrades, and "initiating coverage at neutral." In our recurring column "This Just In," we cover the most headline-worthy upgrades and downgrades, testing the analysts' logic and examining their records to help you decide whether they're worth listening to at all. And in "Get to Know a Guru," we use upgrade and downgrade news as a springboard to introduce you to some of the lesser-known names in analyst-land. Up this week: Rodman & Renshaw.

Profiles in punditry
As a general rule, analysts like to post their ratings in the dead of night. Some say this is because the analysts want to avoid "moving the market" with their news. Others surmise that, when market-moving news comes out after the close of trading one day, the analysts like to sneak their changes of opinion out before trading opens the next day -- so as to look more prescient than they actually were. Whatever the true reason, it's almost unheard of for analysts to downgrade a stock in the middle of the trading day.

Speaking of unheard of, yesterday afternoon -- in the middle of the trading day, no less -- a firm I had never heard of before came out with a downgrade on the stock of micro-cap cancer researcher Vion Pharmaceuticals. The firm: Rodman & Renshaw. The reason: According to the analyst, an FDA decision to halt phase 3 clinical trials of Vion's Cloretazine leukemia drug on safety concerns raises "uncertainty surrounding the clinical development plan." And how.

I'll get back to Vion in a moment, but the main purpose of this column isn't to investigate the investability of tiny biotechs -- it's to pull back the veil of anonymity shrouding analysts who recommend these kinds of investments. If I've never heard of Rodman & Renshaw, I'm betting there are a lot of other Fools out there who likewise haven't a clue who these guys are, or whether the firm's opinions should carry any weight. We're going to answer both those questions right now.

Who is Rodman & Renshaw?
That's the question of the hour. Fortunately, on Motley Fool CAPS, we track this firm and know the answer. Here's what CAPS has to say about R&R: "Rodman & Renshaw is a privately-held, full-service investment bank focusing its financial products and services on emerging growth companies. The Research Department consists of analysts with in-depth expertise in their respective industries. Analysts strive to identify high-quality, undervalued companies that are underfollowed by the broader market."

Further digging reveals a firm with a unique history. Founded in 1951 as a private partnership, R&R has over the years been an NYSE-listed public company and a subsidiary of the Mexican state before returning to private ownership in 1998. With about a half-dozen senior analysts on staff, the bank's research department bills itself as especially skilled in technology and biotech -- but a glance at R&R's coverage list shows that this firm is first and foremost a biotech shop, and its forays outside that sphere are few and far between.

Are these guys any good?
So much for the firm's biography. What we really want to know about is its resume. When R&R speaks, should investors listen?

There's no nice way to say this: No, you absolutely should not listen to anything Rodman & Renshaw has to say. I don't mean to sound harsh, but R&R's record is simply abysmal. On CAPS, we hide its rating behind the fig leaf of an "Under 20" euphemism. But you can assume the firm's true rating is very low indeed -- because its overall CAPS score is negative, and its 36% accuracy rating tells you that R&R is wrong nearly twice as often as it's right. For instance:

R&R Says:
CAPS Says (out of 5):
R&R's Pick Lagging S&P By:

Hollis-Eden Pharmaceuticals (Nasdaq: HEPH)
Outperform
**
65 points

Vertex Pharmaceuticals (Nasdaq: VRTX)
Outperform
****
38 points

Collagenex Pharmaceuticals (Nasdaq: CGPI)
Outperform
*
22 points

Imclone (Nasdaq: IMCL)
Outperform
**
9 points



Of course, every dog has its day. R&R's good days were when it picked stocks like:

MK Says:
CAPS Says:
R&R's Pick Beating S&P By:

Gilead Sciences (Nasdaq: GILD)
Outperform
****
17 points

XOMA Ltd (Nasdaq: XOMA)
Outperform
***
25 points



Return to Vion
In contrast, the day R&R picked Vion was a bad day indeed -- for investors who followed R&R's advice. According to CAPS, the banker rated Vion a "market outperformer" on May 11. By the time R&R reversed course two weeks later, Vion had already underperformed the market by a stunning 52 points, losing more than half its market cap in the process. Ouch.

Adding insult to injury, it seems investors now consider R&R to be a contrarian indicator. On the day R&R downgraded the stock, Vion's shares ticked up 5%.

If you can't say anything nice ...
Let's not end this column on a down note, though. I do have one nice thing to say about R&R: Its top-performing pick in all the time we've tracked it on CAPS is one of only two underperform ratings it has assigned (out of 43 total picks). Both underperform ratings, by the way, are in the green -- so perhaps pessimism is an attitude R&R should adopt more often. (Find out which two stocks got the thumbs-down from R&R when you check out its CAPS page.)

Meanwhile, if you'd like to hear from an analyst with a truly stellar record of calling Vion right, click on over to Vion's CAPS page. There you'll learn that the "analyst" who knows Vion best is no analyst at all, but an ordinary, individual investor just like you and me.

[Ackergaul]

auch noch zur Info... Ich habe ja schon mal Bioenvision ("Konkurent" zu Vion mit Clorofabine) erwähnt. Heute ist die Meldung draussen, das sie übernommen sind. Spielt aber eigentlich keine Rolle für Vion.

Genzyme Corporation to Acquire Bioenvision, Inc.
Tuesday May 29, 9:09 am ET
To Gain Exclusive, Worldwide Rights to Clofarabine


CAMBRIDGE, Mass. and NEW YORK, May 29 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ - News) and Bioenvision, Inc. (Nasdaq: BIVN - News) announced today that they have reached an agreement under which Genzyme will acquire Bioenvision in an all cash transaction valued at $5.60 per outstanding common share, or approximately $345 million, representing a premium of approximately 50 percent over the last twenty trading day average. The transaction is expected to be approximately six cents dilutive in 2007, slightly dilutive to break-even in 2008, and accretive in 2009.
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With this transaction, which has unanimous Bioenvision Board support, Genzyme takes another significant step in enhancing its existing oncology business by gaining the exclusive, worldwide rights to clofarabine. Bioenvision and Genzyme co-developed clofarabine in Europe where Bioenvision currently markets the product for the treatment of acute lymphoblastic leukemia (ALL) in relapsed and refractory pediatric patients. Clofarabine is also being developed by Genzyme and Bioenvision for significantly larger indications, including use as a first-line therapy for the treatment of adult acute myeloid leukemia (AML). Clofarabine is branded as Clolar® in the U.S. and Canada, where it is marketed by Genzyme for relapsed and refractory pediatric ALL patients. Clofarabine has been granted orphan drug status for ALL and AML in both the United States and European Union.

"Building an international commercial presence for our oncology business has been a focus for the corporation and we are very pleased to reach agreement with Bioenvision on this transaction," stated Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "We are deeply committed to furthering the clinical development of clofarabine and making it available on a global basis so that patients around the world with these very difficult forms of cancer will have access to the therapy."

"Strategically, financially and operationally, this acquisition makes great sense for our business," stated Mark J. Enyedy, senior vice president and general manager of Genzyme Oncology, a business unit of Genzyme Corporation. "We have developed a comprehensive understanding of clofarabine and its clinical potential, and are fully engaged in expanding its use into adult populations, most notably and nearest-term in AML. Full ownership will accelerate the development and commercialization of this important therapy."

Christopher B. Wood, M.D., chairman and chief executive officer of Bioenvision, said, "We believe this transaction brings significant value to Bioenvision shareholders. Genzyme has the global clinical, regulatory and commercial infrastructure to advance clofarabine, as well as very significant experience with the product from its U.S. approval, launch, and continued development and commercialization. We are confident that they will build upon the solid foundation our organization has established in Europe to further expand access to clofarabine for patients with serious unmet medical need."

In addition to clofarabine, Bioenvision also markets Modrenal® (trilostane), approved in the United Kingdom for the treatment of post- menopausal breast cancer following relapse from initial hormone therapy, and has a pipeline in development to address unmet needs in autoimmune disease and infectious disease.

Clofarabine Development

Genzyme and Bioenvision each have robust clinical development programs aimed at expanding clofarabine into adult indications. The National Cancer Research Institute (NCRI), an independent, UK-based cooperative group, is currently enrolling patients in AML-16, a phase 2/3 study in older patients with AML or high-risk myelodysplastic syndromes (MDS), in collaboration with Bioenvision. The trial has two components: one focusing on patients who are candidates for intensive chemotherapy, and another non-intensive component focusing on patients who are not considered fit for intensive chemotherapy. Each component will evaluate the efficacy of clofarabine. Genzyme expects that the results from AML-16 will enhance the data from its own pivotal trials of clofarabine that are currently ongoing in adult AML populations.

Genzyme is advancing a phase 3 study (CLASSIC I) in adult AML patients aged 55 and older and previously treated with at least one, but not more than two, prior induction regimens. It is a randomized, double-blind, controlled study that will compare the combination of Clolar and cytarabine (Ara-C) to cytarabine alone.

A phase 2 pivotal clinical trial (CLASSIC II) evaluating the safety and effectiveness of clofarabine in previously untreated, older adult patients with AML who are unlikely to benefit from standard induction therapy is expected to be fully enrolled later this year. Each of these studies is expected to yield substantial evidence supporting the expansion of the current clofarabine product label, which is expected to occur in 2008.

A separate phase 3 study of clofarabine sponsored by the Eastern Cooperative Oncology Group is expected to begin enrolling patients later this year. This study will focus on previously untreated AML patients over the age of 60 who are considered suitable for standard induction chemotherapy.

Clolar is indicated in the U.S. for the treatment of pediatric patients aged 1 to 21 years old with relapsed or refractory ALL after at least two prior regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

Genzyme also is actively exploring additional therapeutic indications for Clolar, including in MDS and bone marrow transplant.

...

[Ackergaul]

Hups, zumindest wieder seit gestern über der 1$ Marke...


Ob es Trader waren? - Vermutlich. Solange die Daten der angehaltenen Phase III nicht ausgewertet bzw. draussen sind, wird der Kurs Vions wohl ausschließlich von Tradern bestimmt. Vielleicht auch ein zusätzlicher Grund, ist der nahende ASCO Termin.

DENNOCH sollte sich jeder in Erinnerung rufen, dass die Kernaussage des DSMB "kein klinischer Vorteil", aufgrund erhöhter "early death rate" ergab. Was bei der Auswertung für Rückschlüsse gezoge werden können, steht in den Sternen.

[Ackergaul]

für alle, die das Conference Call nicht verfolgt hatten, hier noch mal die schriftliche Version (ist auch besser zu verstehen):

http://secfilings.nasdaq.com/filingFrameset.asp?FileName=000…

May. 23. 2007 / 10:30AM ET, VION - Vion Announces Suspension of Phase III Trial in Relapsed AML




CORPORATE PARTICIPANTS

Alan Kessman

Vion Pharmaceuticals - CEO

Ann Cahill

Vion Pharmaceuticals - VP, Clinical Affairs




CONFERENCE CALL PARTICIPANTS

Vinny Jindal

ThinkEquity Partners - Analyst

Keith Haan

Summer Street Research Partners - Analyst

Joseph Schwartz

Leerink Swann - Analyst

Ren Benjamin

Rodman & Renshaw - Analyst

David Garrett

Fortis Securities - Analyst

Daniel Lay

Analyst

Lee Hartman

Analyst




PRESENTATION




Operator

Good day, ladies and gentlemen and welcome to the Vion Pharmaceuticals conference call. My name is Michelle and I will be your audio coordinator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's conference. (OPERATOR INSTRUCTIONS). As a reminder, this conference is being recorded for replay purposes.

This conference will contain forward-looking statements. Such statements are subject to certain risks, which may cause Vion's plans to differ or results to vary from those expected, including Vion's potential inability to obtain regulatory approval for its products, delayed or unfavorable results of drug trials, the possibility that favorable results of early or preclinical studies or clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including, but not limited to, the risks attendant to the forward-looking statements included under Item 1A, Risk Factors in Vion's annual report on Form 10-K for the year ended December 31, 2006.

In particular, there can be no assurance as to the results of any of the Company's clinical trials, that any of these trials will continue to full accrual or that any of these trials will not be discontinued, modified, delayed or ceased altogether except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events. Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

And now I'll turn over this conference call to Alan Kessman, Chief Executive Officer of Vion Pharmaceuticals. Please proceed, sir.




Alan Kessman - Vion Pharmaceuticals - CEO

Thank you, operator and good morning, everyone. We thank you for joining us on this conference call. With me today is Howard Johnson, our President and CFO; Meg Fitzgerald, our Chief Business Officer; Ann Cahill, our Vice President of Clinical Affairs and Aileen Ryan, our Vice President of Regulatory Affairs.

As most of you know, our lead anticancer agent, Cloretazine, is being studied in two pivotal clinical trials in acute myelogenous leukemia. CLI-037, a Phase III trial in combination with Ara-C in patients with relapsed AML and CLI-043, a Phase II trial, as a single agent in elderly patients with de novo poor-risk AML. Our randomized placebo-controlled Phase III trial in relapsed AML is evaluating 1.5 grams of Ara-C given over three days in a continuous infusion plus or minus 600 milligrams per meter squared of Cloretazine in patients older than 18 years of age with first relapsed AML and a first remission of a least three months but no more than 24 months.

Patients are stratified according to age, greater or less than 60 years and two, length of the first CR, more than or less than 12 months in duration. The primary endpoint for the trial is the objective response rate to find the CR, plus CRp. CRp meaning a complete remission with incomplete recovery of platelet count. Secondary endpoints include time to progression, duration of response, overall survival and toxicity.

We started this trial in March 2005 and in November 2006, reached the halfway point in accrual, 210 patients. A statistical analysis plan for this trial included an interim analysis at 210 patients for both safety and efficacy by the Data Safety Monitoring Board or DSMB.

Prior to the interim analysis, the DSMB had met twice before to review the trial for safety and had recommended that the trial continue to accrue patients. The DSMB has now reviewed the data for the interim analysis and based on their recommendation, we have decided to suspend accrual and patient treatment on the trial until we can fully evaluate all the data generated to date.

The DSMB's recommendation was based on their evaluation that any advantage in complete remission could be compromised by the observed on-study mortality to date. The trial will remain blinded during this medical review. Therefore, we cannot provide you with much additional information at this time.

Additionally, we are unable to provide a definitive timeline necessary for complete review of the data at this time. Our plan would be to advise you of any further developments on the trial as soon as we can. Our other trial in AML, CLI-043, the Phase II trial evaluating Cloretazine as a single agent in elderly patients with de novo poor-risk AML, will continue to accrue patients as planned. We continue to expect that that accrual to this trial will be concluded in the June or July timeframe and that an abstract will be submitted related to this trial at the American Society of Hematology meeting in December 2007.

All of us here at Vion continue to believe in the potential for Cloretazine for the treatment of AML and look forward to the completion of our pivotal Phase II trial and an announcement of data from this trial later this year. We will continue to provide you with as much information about this trial and the Phase III trial medical analysis as soon as we have that information available.

Before I take questions, I just would like to relate to everybody that we absolutely understand the need and desire for information, but I have to remind you that this study was halted, not stopped. Most of you are probably familiar with the fact that when studies get stopped, there is an abundance of information available. But the fact that this study remains blinded really means that we have limited information.

We are in the process of establishing a committee comprised of some internal management people, as well as some outside medical people to review the data to try and come to an answer and be able to provide more information to you, as well as to discuss it with the DSMB. But at this point, before we take questions, I just want to reiterate it is going to be very difficult to satisfy your need for information.

With that, operator, we can now take some questions.






QUESTION AND ANSWER







Operator

(OPERATOR INSTRUCTIONS). Vinny Jindal.




Vinny Jindal - ThinkEquity Partners - Analyst

Hey, guys. I was hoping that you could remind us what the dosage level for the elderly AML trial is of Cloretazine versus what you had on the Phase III?




Alan Kessman - Vion Pharmaceuticals - CEO

It's basically the same doses.




Vinny Jindal - ThinkEquity Partners - Analyst

Okay. Thanks.




Ann Cahill - Vion Pharmaceuticals - VP, Clinical Affairs

It's 600 milligrams of Cloretazine -- per milligrams per metered squared given as a single agent in that Phase II. This is Ann Cahill.




Vinny Jindal - ThinkEquity Partners - Analyst

Great. And is the DSMB's -- is their recommendation based on an analysis of safety activity or are they making kind of a subjective risk-benefit assessment of the drug at that dose level?




Alan Kessman - Vion Pharmaceuticals - CEO

Both. I mean their review was both a safety and efficacy review.




Vinny Jindal - ThinkEquity Partners - Analyst

So did you have to pass a certain threshold on one or both parameters for them to not recommend continuing accrual at this time or was it kind of again a subjective look and saying on a risk-benefit basis, it may not be a good idea to go forward?




Alan Kessman - Vion Pharmaceuticals - CEO

It is really a look on an overall risk-benefit basis and basically that is what they are saying that when they made that statement that any advantage in complete remission may not translate into overall survival advantage. Remember, this was stopped, okay, and the information is still blinded to us.




Vinny Jindal - ThinkEquity Partners - Analyst

Got you. And Alan, what allows the trial to restart and re-enroll? What can change the picture?




Alan Kessman - Vion Pharmaceuticals - CEO

It all depends on what we see from the data and what the answers to try and understand clearly why a potential complete remission advantage does not translate into a survival advantage. And again, I am dealing with blinded information. I know that is a fairly -- since I don't have the statistics or the data in front of us, it is fairly hard to quantify that. But that is really what we have to try to understand is what is causing that. Clearly in our opinion from the conversation that we had with DSMB, it was not readily apparent to them, but there is something for us to look at to try to understand that.




Vinny Jindal - ThinkEquity Partners - Analyst

Okay. And I can understand that you may not be able to answer the question, but are the question marks surrounding greater potential survival is that you are getting a lot of patience with complete response, however a lot of patients with toxicity are dying earlier and that you were balancing each other out or is it that you are not seeing the original efficacy in patients to suggest that patients are getting to even complete response as a surrogate endpoint for survival?




Alan Kessman - Vion Pharmaceuticals - CEO

What I do know is that there was not a problem with the futility side. There is efficacy. From an efficacy standpoint, there was not a problem with the futility side. But I can't answer the rest of your question.




Vinny Jindal - ThinkEquity Partners - Analyst

Okay. And then one last question and I will hop back in the queue and this is for Meghan or for Ann. Your analysis of the drug and your understanding of its features, is the possibility of the toxicity of that counterbalance and the activity that Alan just mentioned, is that due to a combination effect or is that mostly in your view kind of a reflection of Cloretazine's myelosuppressive effects?




Ann Cahill - Vion Pharmaceuticals - VP, Clinical Affairs

Hi, Vinny. This is Ann. Of course, we can't comment on data from combination of Cloretazine and Ara-C from this trial fully yet, but I can tell you from looking at the other trials and from speaking to investigators and based on our previously published data, the feeling is that the drug has demonstrated anti-leukemic activity and will find its place in treatment of AML.




Vinny Jindal - ThinkEquity Partners - Analyst

Okay. Fair enough. Thanks so much for taking the questions, guys.




Operator

Keith Haan.




Keith Haan - Summer Street Research Partners - Analyst

Hi, just a couple of questions to follow up. I think at the presentation at ASH regarding some of the demographics of this study, there was about a 9% or so early death rate and that was blinded obviously, so we don't know what the early death rate was for each individual arm. So maybe you could comment on how that 9% or 10% or so early death rate might compare to what you would see with Ara-C alone in this population?




Ann Cahill - Vion Pharmaceuticals - VP, Clinical Affairs

This is Ann Cahill. Again, at ASH of '06, we published a number of early death of 9%. So I think at that time, we were comparing that or put that out for people to interpret against historical control. I cannot tell you from again this blinded study what the early death rate is for Ara-C versus the combination arm in the study. Only on -- I can tell you that the early death rate in the ASH poster was '06 and that compared to what had been previously published on Ara-C in the literature.




Keith Haan - Summer Street Research Partners - Analyst

So it was relatively comparable to what was with Ara-C in the literature?




Ann Cahill - Vion Pharmaceuticals - VP, Clinical Affairs

As a reminder, there is not a depth of literature on the continuous infusion Ara-C that we are using in this Phase III study. So it really was looking at Ara-C given in a number of different schedules and doses. So again I can't tell you that this was apples to apples based on the ASH '06 Ara-C or on study early death rate given that the literature of Ara-C is really checkered in dose and schedules, but within that range, it was certainly no worse and at that time, was comparable or better.




Keith Haan - Summer Street Research Partners - Analyst

Okay. Can you remind us a little bit the Phase I/II work that you have looking at Cloretazine in combination with Ara-C? Was there a consolidation in maintenance there and can you compare and contrast that to the consolidation and maintenance that patients are getting in the Phase III study?




Ann Cahill - Vion Pharmaceuticals - VP, Clinical Affairs

I can briefly give you some bullets from the Phase I published study of Cloretazine and continuous infusion Ara-C. That was a dose escalation study and those patients were quite refractory, had seen many, many previous regimens for their AML. So the patient population differed in that important way.

Also -- that is because it was a Phase I study. This study allowed -- the Phase I study allowed retreatment; it did not have a maintenance. That differs from the Phase III study, which has the possibility of an induction two and also has a consolidation phase. But again neither the Phase I or the Phase III study have a maintenance.




Keith Haan - Summer Street Research Partners - Analyst

Okay. And last question, if this study is permanently halted and the Phase II study in de novo AML in the elderly is positive, how do you think of filing in an ultimate approval? Was the assumption that the Phase III study could serve to some extent as a confirmatory study for the Phase II under an accelerated approval process and does that change if the Phase III study is halted altogether?




Alan Kessman - Vion Pharmaceuticals - CEO

I think from an overall standpoint when we look at it from a registration standpoint, we are not ready at this point again without the data from 43 to make a decision whether accelerated or full approval is available to us. But if it does go with accelerated approval then certainly we would have to consider some form of a Phase III confirmatory trial, which we certainly will -- we understand and have understood all along.




Keith Haan - Summer Street Research Partners - Analyst

Okay. Thanks.




Operator

Joseph Schwartz.




Joseph Schwartz - Leerink Swann - Analyst

Thank you. I was wondering were the same criteria used in the prior two DSMB decisions before to continue the trial?




Alan Kessman - Vion Pharmaceuticals - CEO

Since I was not in the meeting, I can't answer that question.




Ann Cahill - Vion Pharmaceuticals - VP, Clinical Affairs

This is Ann Cahill. In the two previous DSMB meetings, they looked at safety only.




Joseph Schwartz - Leerink Swann - Analyst

Okay. And were there different criteria used in this most recent one now, the interim analysis to decide whether to halt versus to stop enrollment?




Ann Cahill - Vion Pharmaceuticals - VP, Clinical Affairs

No, no.




Joseph Schwartz - Leerink Swann - Analyst

And lastly, can you give us a sense of how much of your R&D is devoted towards the Phase III program versus the Phase II and everything else?




Alan Kessman - Vion Pharmaceuticals - CEO

When you say R&D -- you really mean the development because there is not much research.




Joseph Schwartz - Leerink Swann - Analyst

Right. I'm just trying --




Alan Kessman - Vion Pharmaceuticals - CEO

Research. Most of our development work, which is really primarily the registration work, has been focused on the filing assuming 043 still is our primary registration path and our initial registration path. So most of our focus is on 043 from a development standpoint.




Joseph Schwartz - Leerink Swann - Analyst

So it doesn't sound like there is too much of an implication for reduced cash burn here?




Alan Kessman - Vion Pharmaceuticals - CEO

As of today, that is correct.




Joseph Schwartz - Leerink Swann - Analyst

Okay, thanks very much.




Alan Kessman - Vion Pharmaceuticals - CEO

Other than the fact that the patients would not be put on the trial from a cash standpoint.




Joseph Schwartz - Leerink Swann - Analyst

Great. Thanks.




Operator

Ren Benjamin.




Ren Benjamin - Rodman & Renshaw - Analyst

Thanks for taking the call. Can you -- the trial that you have right now, did you guys put this on hold or did the FDA or has the FDA put you on hold? Can you just give us some more clarity around this?




Alan Kessman - Vion Pharmaceuticals - CEO

We suspended the trial. It has not been put on hold.




Ren Benjamin - Rodman & Renshaw - Analyst

Do you have to go now through the FDA and do discussions have to begin as to how to proceed going forward or is this all completely on your own?




Alan Kessman - Vion Pharmaceuticals - CEO

We made the decision to suspend. We are in the process today of notifying all the regulatory authorities, all the investigators on both trials and we will have whatever discussions the FDA wants to have with us as we move forward.




Ren Benjamin - Rodman & Renshaw - Analyst

Is it possible that the ongoing Phase II trial sort of based on the DSMB analysis could be placed on hold as well?




Alan Kessman - Vion Pharmaceuticals - CEO

I can't answer that. It is an open-ended question. Possible? How could I answer the question possible? To our understanding, we have seen nothing to date on 043 that would cause us any undue alarm from a safety standpoint. But that doesn't mean that somebody else looking at the data would not come to a different conclusion, but I have no ability to say there is absolutely no possibility. I just think it is -- we would -- we, at this point, don't see any reason for it.




Ren Benjamin - Rodman & Renshaw - Analyst

How many patients have enrolled into the ongoing Phase II trial right now?




Alan Kessman - Vion Pharmaceuticals - CEO

We have not released that public information, but again what I can tell you -- you can do a pretty close interpretation. We have always said the trial will accrue to 85 patients and like we have said I think consistently for the last couple of months, we expect to complete accrual in June or July. So you can assume that we are pretty close.




Ren Benjamin - Rodman & Renshaw - Analyst

Okay. And then just based on an earlier question, you mentioned that it wasn't really a problem with the futility analysis, it seemed like the futility analysis from an efficacy point of view seemed to have been fine. However, maybe the safety hurdle has changed somewhat so then in the overall risk-reward benefit, the DSMB decided to or suggested that the trial should be halted. Is that correct? I mean the efficacy seems to be about right to what you were originally figuring the trial would show, but there is just a safety signal here that was not originally anticipated.




Alan Kessman - Vion Pharmaceuticals - CEO

I think in your words, roughly yes.




Ren Benjamin - Rodman & Renshaw - Analyst

Okay. And then just finally regarding burn rate. Since you are halting the trial and no new patients are coming on board, is it not unreasonable to assume that the burn rate will go down until we get a sort of final decision or the trial resumes again.




Alan Kessman - Vion Pharmaceuticals - CEO

We will still be monitoring the patients so that we will still have our CRO costs. The only major savings -- quantify this -- the only significant savings that we would see is the fact that patients wouldn't be going on trial right now. Of course, we would hope to spend that money in the future, but basically that may be more of a deferral than an absolute savings assuming that the trial -- that the trial either restarts as is or with some modifications. So basically in the short term, yes; there is some burn, but it is really just the external cost of not putting new patients on.




Ren Benjamin - Rodman & Renshaw - Analyst

Fair enough. Okay. Thank you very much.




Operator

David Garrett.




David Garrett - Fortis Securities - Analyst

Good morning.




Alan Kessman - Vion Pharmaceuticals - CEO

Good morning, David.




David Garrett - Fortis Securities - Analyst

You say that based on the analysis -- the data that you can see from the Phase II pivotal right now, that there is no safety concern. Can you discuss what the induction death rate is in that trial?




Alan Kessman - Vion Pharmaceuticals - CEO

No. I mean we haven't made that public yet. The trial is still going on and we will at the appropriate time reveal that. Although I can just repeat what I said is that we have -- our SAE committee meets regularly. We certainly have not heard of anything from any of our investigators. There was recently a conference call with our investigators and nothing of any unusual nature was raised at that meeting.




David Garrett - Fortis Securities - Analyst

Thanks.




Operator

(OPERATOR INSTRUCTIONS). [Daniel Lay].




Daniel Lay Analyst

Thanks for taking my call. The question is twofold. First of all, with the recent private placement that you completed, you raised I guess roughly $60 million in cash. Is the halting of this Phase III trial going to trigger any breach of covenants under that document or under that private placement so that you could be compelled to essentially have to come up with those dollars at some point here in the near term?




Alan Kessman - Vion Pharmaceuticals - CEO

No.




Daniel Lay Analyst

Okay. Second half of that question then. Under the terms of that private placement, my understanding is that the lower the stock price, the more shares ultimately are going to actually be issued as a result of that document. Are you worried about increased dilution going forward over the next couple of years?




Alan Kessman - Vion Pharmaceuticals - CEO

I am not sure -- are you referring to the fact that we have the ability to pay the interest in shares?




Daniel Lay Analyst

Yes. I mean obviously at this point with the stock down here over 50% today, you would be ponying up cash I assume rather than shares.




Alan Kessman - Vion Pharmaceuticals - CEO

Yes, but I believe my understanding of the document is that there is a minimum number the stock price will not go below, by the NASDAQ rules, to issue the interest shares. So there is a minimum to the floor there. At this point, I am not worried about it.




Daniel Lay Analyst

Thank you.




Operator

(OPERATOR INSTRUCTIONS). [Lee Hartman].




Lee Hartman Analyst

Good morning. I was wondering if you could review the presentations or the abstracts that are available on the full developmental program for ASCO coming up and would this announcement today affect any of those?




Alan Kessman - Vion Pharmaceuticals - CEO

This announcement will not affect any publication that we have going at ASCO. I am trying to think now while you ask -- wasn't prepared for that one. There will be one on small cell and I believe the NCI is doing one on Triapine.




Lee Hartman Analyst

That was my understanding as well, so I just wanted to doublecheck.




Alan Kessman - Vion Pharmaceuticals - CEO

Okay.




Lee Hartman Analyst

Thank you.




Operator

I am currently showing we have no further questions at this time. I'd like to turn the presentation back over to management for any closing remarks.




Alan Kessman - Vion Pharmaceuticals - CEO

Thank you and again I want to thank all of you for participating on this call. As you know, we put this together very quickly because this information has just recently come to us. I want to reassure you that we here at Vion absolutely believe in Cloretazine. We believe that it is a drug that can help patients with AML. We absolutely believe in our trials.

We believe that this pickup at this point with the proper amount of work, there is a solution to every problem and we are going to put our best minds to it and we certainly believe and continue to believe very strongly in the 043 trial. We have always focused recently on 043 trial as our primary move to our first level of registration and we continue to believe it will be our first shot on goal and we are certainly hopeful that nothing will come from this that will affect 043.

So we see this, yes, as a temporary setback, but we are still fighting the battle. We still believe we have a winning team. I believe we have a winning drug and we are not going to let this stop us from our goal of getting our ball across the goal line. So thank you very much for attending the call and hope to see you and talk to you soon in the near future with at least a more positive initial press release. But again, we hope to bring this ball across the goal line in the very near future. Thank you.




Operator

Ladies and gentlemen, thank you for your participation in today's conference call. This does conclude your presentation and you may now disconnect.

[Mihalis]

Hallo Ackergaul!
Gute Arbeit.
... but I have to remind you that this study was halted, not stopped.

[Ackergaul]

Antwort auf Beitrag Nr.: 29.607.039 von Mihalis am 03.06.07 12:12:11

Hi Mihalis,

schon klar... zudem ist der Trial von Vion angehalten worden und NICHT seitens der FDA! Jedoch habe ich momentan Zweifel, dass der Trial fortgeführt wird. Zumindest wird dieser zumindest modifiziert (dosis wird neu angepasst oder oder oder) oder halt komplett aufs Eis gelegt. Dies wird aber zusammen mit der FDA noch geklärt.
Juni / juli ist der CLI-043 Trial komplett. Im Dezember vorraussichtlich ausgewertet und dann gibts vielleicht eine Zulassung... Ausserdem sollten heute und morgen noch die ASCO News kommen (Hoffentlich sind es auch News!).

Grüße!

[Mihalis]

Antwort auf Beitrag Nr.: 29.616.165 von Ackergaul am 03.06.07 18:14:55

1,50 in pre-market

[cyberhai]

http://biz.yahoo.com/prnews/070604/nym064.html?.v=74

Vion Pharmaceuticals Presents Updated Clinical Data from a Phase II trial of Cloretazine(R) (VNP40101M) in Patients with Relapsed or Refractory Small Cell Lung Cancer
Monday June 4, 8:00 am ET

NEW HAVEN, Conn., June 4 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION - News) announced that it presented updated clinical data in a poster session at the 43rd Annual Meeting of The American Society of Clinical Oncology (ASCO) on its lead anticancer agent Cloretazine® (VNP40101M) as a single agent in a Phase II trial in patients with relapsed or refractory small cell lung cancer.

The Phase II trial evaluates Cloretazine® (VNP40101M) in two separate subpopulations of small cell lung cancer: (i) sensitive relapse disease and (ii) refractory disease. Sensitive relapse disease is defined as relapse after three months of first-line therapy and refractory disease is defined as relapse within three months of first-line therapy. Data are presented on a total of 48 evaluable patients: (i) 20 patients in the sensitive relapse arm and (ii) 28 patients in the refractory arm.

Patients on the trial initially received 125 mg/m2 of Cloretazine® (VNP40101M) weekly for three weeks, every six weeks. This dose was later reduced by protocol amendment to 100 mg/m2 weekly for three weeks every six weeks due to the incidence of grade 3 and 4 thrombocytopenia at the initial dose level.

Of the 20 evaluable patients on the sensitive relapse arm, there have been 6 patients with partial response and one patient awaiting confirmation of response (overall, 35% response rate), and 3 patients have stable disease. Four of 13 sensitive relapse patients responded at the 125 mg/m2 dose level and 3 of 7 sensitive relapse patients responded at the 100 mg/m2 dose level. Of the 28 patients with refractory disease treated with Cloretazine® (VNP40101M), 1 patient achieved a partial response and 3 patients have demonstrated stable disease.

A total of 55 patients were evaluable for toxicity. Grade 3 and 4 thrombocytopenia was observed in 14 of 31 patients (45%) at the 125 mg/m2 dose level. Thrombocytopenia was substantially reduced at the 100 mg/m2 dose, where 5 of 24 patients (21%) had grade 3 or 4 thrombocytopenia.

Small cell lung cancer metastasizes frequently to the bone marrow and the brain. Eighteen patients on the study presented with brain metastases. Of these patients, 3 achieved a partial systemic response and 3 demonstrated stable disease.

Dr. F. Anthony Greco, Director of the Sarah Cannon Research Institute in Nashville, Tennessee, commented, "Cloretazine® (VNP40101M) has impressive activity in small cell lung cancer in the second-line setting, including activity against brain metastases, and further evaluation is warranted."

Ann Cahill, Vion's Vice President, Clinical Development, said, "Our solid tumor clinical development plan for Cloretazine® (VNP40101M), which includes our Phase II trial in small cell lung cancer, and the recently completed trials in adult and pediatric brain tumors, is an important part of the overall clinical development program for this novel alkylating agent." Ms. Cahill added, "We are encouraged by this promising data in small cell lung cancer."

Additional data from a Phase I trial conducted by the Pediatric Brain Tumor Consortium of Cloretazine® (VNP40101M) as a single agent in pediatric brain tumors will be presented at the ASCO Annual Meeting in poster U1 in S Hall A2 at the McCormick Place Convention Center on Monday, June 4, 2007 from 1 to 5 p.m.

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine® (VNP40101M), a unique alkylating agent, is being evaluated in a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. An additional trial of Cloretazine® (VNP40101M) as a single agent in small cell lung cancer is also underway. Triapine®, a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating VNP40541, a hypoxia-selective compound, and hydrazone compounds. The Company also is seeking development partners for TAPET®, its modified Salmonella vector used to deliver anticancer agents directly to tumors. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com.

[Mihalis]

Vion getting back on track..... good news out of ASCO.

[Ackergaul]

Antwort auf Beitrag Nr.: 29.637.924 von Mihalis am 04.06.07 22:14:59

Die ASCO News im einzelnen:

Zuerst zu SCLC. Die Daten würde ich mit In-Line bezeichnen. Cloretazine hat das (Positive) aus Phase I bestätigt, zudem noch die Verringerung der side effects von 45% @ 125 mg/m2 Dosis nach 21% @ 100 mg/m2 Dosis.

A phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases.
Sub-category: Small Cell Lung Cancer
Category: Lung Cancer
Meeting: 2007 ASCO Annual Meeting

Abstract No: 7724
Citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 7724
Author(s): T. Mekhail, S. Gettinger, G. Blumenschein, R. Axelrod, M. Haigentz, M. J. Guarino, A. L. Cahill, D. Spigel, F. A. Greco
Abstract: Background: Relapsed or refractory SCLC patients (pts) have a poor prognosis. Median survival at relapse is 2-3 months; brain metastases (mets) are common. Alkylating agents have demonstrated activity in SCLC. Cloretazine is a new alkylator that is active against selected alkylating agent resistant tumor cell lines. Xenograft models show distribution across the blood-brain barrier. This study investigates VNP40101M safety and activity in SCLC patients who have relapsed or are refractory to standard 1st line chemotherapy. Methods: Pts are entered in 2 groups based on response to prior chemotherapy: sensitive relapse (chemotherapy-free interval >3 months); or resistant/refractory (chemotherapy-free interval <3 months). Eligibility criteria include: measurable or evaluable disease; life expectancy of >2 months; and ECOG PS of 0-2. Pts with brain mets are eligible. 31 pts received VNP40101M IV at a starting dose of 125 mg/m2/wk × 3, every 6 weeks. Due to a high incidence of grade 3-4 thrombocytopenia (34%), an amended protocol reduced the dose of VNP40101M to 100 mg/m2 at the same schedule. 13 pts received the reduced dose. Pts are evaluated by RECIST criteria after each 6-week cycle. Results: 44 of 87 planned pts have been treated at 7 sites. Of 41 evaluable pts, 21 patients have sensitive relapse disease, and 20 have resistant/refractory disease. Median age is 64 years (44-86). Median number of cycles received is 1 (1-3). Grade 3-4 thrombocytopenia was seen in 11/31 pts at the 125 mg/m2 dose and 3/13 pts at the 100 mg/m2 dose. Gr 3-4 non-hematologic toxicity is rare, except for fatigue (10%) and GI effects (10%). The response rate (PR) is 6/21 (29%) in the sensitive relapse group, and 1/20 (5%) in the resistant/refractory group. 2/6 PRs, in the sensitive relapse group, occurred at the reduced dose level. 16 pts had brain mets at study entry. Of these, there were 3 PRs (2 with measurable regression of brain mets) and 3 stable diseases. Conclusions: The study is ongoing to confirm efficacy and safety. VNP40101M has activity against SCLC in the 2nd line setting including pts with brain metastases; further study is warranted.



Dann zum zweiten Punkt - Brain Tumor. Für mich selber superschwer einzuschätzen, aber besonders effektiv hört sich dass nicht an (1 Objective responses). Gut letztendlich ging es auch mehr darum die korrekte Dosis für die 2. Phase zu finden!

Phase I trial of VNP40101M in children with recurrent brain tumors--A Pediatric Brain Tumor Consortium (PBTC) study.
Sub-category: CNS Tumors
Category: Central Nervous System Tumors
Meeting: 2007 ASCO Annual Meeting

Abstract No: 2059
Citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 2059
Author(s): S. Gururangan, C. Turner, C. F. Stewart, M. Kocak, T. Y. Poussaint, J. M. Boyett, L. E. Kun, V. Karsten, S. L. Gerson, H. S. Friedman
Abstract: Background: VNP40101M, a novel DNA alkylating agent and a potent inhibitor of alkylguanine alkyl transferase (AGT) in pre- clinical studies, was evaluated in a phase I study in children with recurrent brain tumors. Methods: VNP40101M was given intravenously (i.v) daily for 5 days q 6 weeks up to 8 cycles. Using the continual reassessment method, dose escalation was performed independently in pts stratified based on intensity of prior therapy (stratum I-less-heavily pre-treated; stratum II- heavily pre-treated). Dose limiting toxicities (DLTs) and responses were assessed at the end of the first and 2nd cycles of treatment, respectively. Correlative studies included pharmacokinetics and measurement of AGT activity in peripheral blood mononuclear cells (PBMC) before and after treatment. Results: 41 eligible pts (stratum I- 19, stratum II- 22; median age 9.3 yrs, range 0.9 to 21.5) were enrolled on this study. Dose levels (in mg/m2/day) evaluated in Stratum I were 45, 60, and 78 mg; In Stratum II 20, 30, 45, and 60 mg. DLT in evaluable pts was myelosuppression (grade IV neutropenia for > 7 days or any grade IV thrombocytopenia) and occurred in 4/16 pts in stratum I [45 mg (n=1/12), 60 mg (n=1/2), 78 mg (n= 2/2)] and 3/19 pts in stratum II [45 mg (n= 3/4), 60 mg (n=0/1), 30 mg (n= 0/12), and 20 mg (n= 0/2)] respectively. Other significant toxicities post first course included renal failure (n=2), pulmonary (n=2), and fatal infection (n=1). PK studies showed median (range) terminal half-life of 62 mins (7.3 to 522 min). The MTDs in stratum I and II were 45 mg/m2/day and 30 mg/m2/day daily for 5 days q 6 weeks, respectively. Objective responses were observed in one pt each with brain stem glioma and medulloblastoma respectively. PBMC AGT levels did not decrease following VNP40101M treatment. Conclusions: The recommended pediatric phase II dose of VNP40101M given i.v daily for 5 days q 6 weeks is 45 mg/m2/day in less-heavily treated and 30 mg/m2/day in heavily treated pts.



Insgesamt O.K. bis Gut aber innerlich habe ich mehr erwartet...

[Ackergaul]

Antwort auf Beitrag Nr.: 29.651.700 von Ackergaul am 05.06.07 18:47:28

und zu Triapine auch noch was von der ASCO:

High incidence of symptomatic methemoglobinemia (metHb) in Asian patients (pts) treated with 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP, triapine) and gemcitabine (GEM) in a second-line phase II trial of metastatic non-small cell lung cancer.
Sub-category: Non-Small Cell Lung Cancer
Category: Lung Cancer
Meeting: 2007 ASCO Annual Meeting

Abstract No: 18207
Citation: Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 18207
Author(s): B. Ma, E. H. Tan, T. Mok, K. C. Lam, R. Soo, S. S. Leong, L. Z. Wang, F. Mo, A. T. Chan, B. C. Goh
Abstract: Background: Triapine (Vion Pharmaceuticals) is an inhibitor of ribonucleotide reductase that can enhance GEM uptake in GEM-resistant cell lines. Clinically significant metHb has been rarely reported with triapine & G6PD-deficient pts maybe more susceptible. This multicenter study evaluated the activity & safety of combined triapine-GEM in pts with metastatic NSCLC who had progressed despite prior response or disease stabilization to 1st line platinum-GEM regimen.
Methods: Eligible pts were treated with triapine (105mg/m2) as 4-hr IV infusion, followed by GEM (1g/m2) over 30-min on days 1, 8 & 15, repeating every 28 days for 6 cycles. G6PD-deficient pts were excluded.
Results: 6 males & 6 female Asian pts (median age: 65 yrs) received a median no. of 2 cycles (range 1-6 cycles). At a median follow-up of 4.6 mos, no response was seen. 4 pts had stable disease. Median time to progression was 3 mos (95% CI: 1.7-9.1 mos). Gr 3-4 toxicities included neutropenia (gr 3, 2 pts), hypoxia (gr 3, 3 pts) & dyspnea (gr 3, 1 pt). There were no treatment-related deaths & all pts remained alive at analysis. 4 pts developed symptomatic metHb during, or < 4 hrs of stopping triapine. This was manifested as dyspnea &/or hypoxia, associated with an oxygen saturation of <90% at room air. Arterial metHb assay performed during the hypoxic episode showed a metHb level of up to 15% of total concentration of hemoglobin ([Hb]), which fell to < 5% of [Hb] within 4-6 hrs of stopping triapine. All pts recovered with conservative treatment & none required reversal with methylene blue. 3 out of the 4 pts were able to continue treatment after dose-reduction of triapine.
Conclusions: The cause of the relatively high incidence of triapine-related symptomatic metHb was unclear in this Asian cohort. This study was terminated prematurely due to lack of response.


Hört sich hier weniger Gut an. Bin auch nach wie vor nicht so von Triapine überzeugt, aber dass kann sich ja noch ändern!

[Ackergaul]

und noch was - jetzt wieder zu Cloretazine (und wieder mehr positivem):

Activity of VNP40101M (Cloretazine) in the treatment of CNS tumor xenografts in athymic mice

Michael A. Badruddoja 1, Stephen T. Keir 2, Ivan King 3, Joseph Zeidner 2, James J. Vredenburgh 4, Lawrence H. Muhlbaier 5, Darell D. Bigner 6, Henry S. Friedman 7*
1 Center for Neurosciences, University of Arizona, Tucson, AZ 85721, USA
2 Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA
3 Vion Pharmaceuticals, New Haven, CT 06511, USA
4 Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA
5 Department of Biostatistics/Bioinformatics, Duke University Medical Center, Durham, NC 27710, and Vion Pharmaceuticals, New Haven, CT 06511, USA
6 Departments of Surgery and Pathology, Duke University Medical Center, Durham, NC 27710, USA
7 Departments of Surgery, Pathology, and Pediatrics, Duke University Medical Center, Durham, NC 27710, USA

Abstract

VNP40101M, or 1,2-bis(methylsulfonyl)-1-(2-choloroethyl)-2-(methylamino)carbonylhydrazine (Cloretazine), is a bifunctional prodrug that belongs to a class of DNA-modifying agents--the sulfonylhydrazines--that has been synthesized and been shown to have activity against a wide spectrum of xenografts. The current study was designed to assess the activity of VNP40101M administered at a dose of 18 mg/kg daily for five days against a panel of human adult and pediatric CNS tumors growing subcutaneously or intracranially in athymic nude mice. The results demonstrated statistically significant (p < 0.05) growth delays of 15.0, 8.3, 51.0, 60+, 60+, and 60+ days in subcutaneous xenografts derived from childhood glioblastoma multiforme (D-456 MG), childhood ependymoma (D-528 EP and D-612 EP), childhood medulloblastoma (D-425 MED), and adult malignant glioma (D-245 MG and D-54 MG), respectively, with corresponding tumor regressions in 10 of 10, 4 of 10, 8 of 10, 9 of 10, 9 of 10, and 10 of 10 treated mice, respectively. Delayed toxicity was seen more than 60 days after treatment, with 23 deaths in 100 treated animals, despite a median weight loss of only 0.06%. In mice bearing intracranial D-245 MG xenografts, treatment with VNP40101M at a dose of 18 mg/kg daily for five days produced a 50% increase in median survival compared with controls. Additional experiments conducted against subcutaneous D-245 MG xenografts by using reduced doses of 13.5 or 9.0 mg/kg daily for five days demonstrated tumor growth delays of 82.2 and 53.5 days, with corresponding tumor regressions in 8 of 9 and 9 of 10 treated mice, respectively (all values, p < 0.001), with one toxic death. These findings suggest that VNP40101M is active in the treatment of a wide range of human central nervous system tumors and warrants translation to the clinic.

[Ackergaul]

Das ASCO-Präsentations Poster zur Phase II: SCLC

http://www.vionpharm.com/pdf/ASCO07-039.pdf

[Mihalis]

Heute wird ganz stark UP gehen!

Vion Pharmaceuticals Presents Clinical Data from a Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML Patients with Unfavorable Cytogenetics at EHA Meeting



Last Update: 8:00 AM ET Jun 11, 2007


NEW HAVEN, Conn., June 11, 2007 /PRNewswire-FirstCall via COMTEX/ -- Vion Pharmaceuticals, Inc. (Nasdaq Capital Market: VION) announced that it presented clinical data in a poster session at the 12th Congress of the European Hematology Association (EHA) Meeting in Vienna, Austria on its lead anticancer agent Cloretazine(R) (VNP40101M) as a single agent in a multi-center international Phase II clinical trial in a subset of elderly patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and unfavorable cytogenetics.
The Phase II trial was conducted from March 2004 to May 2006. The study treated 129 patients of 60 years of age or older with previously untreated AML or high-risk MDS. Previously data were presented on 104 patients (Giles et al, Journal of Clinical Oncology, January 1, 2007). Treatment consisted of Cloretazine(R) (VNP40101M) in a 600 mg/m2 dose administered in a 30-60 minute infusion on day 1 (second induction allowed) and provided the option for an additional 400 mg/m2 as consolidation for responders (complete remission (CR) or complete remission with incomplete platelet count (CRp). The primary endpoint was overall response (CR and CRp). Overall survival and relapse-free survival were also analyzed.
Data were presented at the EHA Meeting in a subset of 59 patients with unfavorable cytogenetics. Of these patients, 28 (47%) had secondary AML, 21 (36%) had de novo AML, and 10 (17%) had high-risk MDS. Overall, the response rate in patients with unfavorable cytogenetics was 25%. Response by diagnosis was: de novo AML (48%); MDS (30%) and secondary AML (7%). Twelve (20%) patients died within 30 days of receiving induction treatment. The majority of early death was in patients with secondary AML and was due to disease progression.
Dr. Norbert Vey, head of the Leukemia Program, Department of Hematology, at the Institut Paoli-Calmettes in Marseille, France, commented, "Patients with unfavorable cytogenetics have traditionally not responded well to induction chemotherapy, so the activity of Cloretazine(R) (VNP40101M) in this setting is particularly encouraging."
Ann Cahill, Vion's Vice President, Clinical Development, said, "Elderly AML patients with unfavorable cytogenetics have few available treatment options." Ms. Cahill added, "Our ongoing pivotal Phase II trial is designed to confirm the activity of Cloretazine(R) (VNP40101M) in poor-risk patients, including those with unfavorable cytogenetics."
A pivotal Phase II clinical trial in elderly patients with de novo poor- risk AML is underway currently in over 20 sites in North America and Europe. Completion of accrual to this trial is expected in June or July 2007.
Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is being evaluated in a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. An additional trial of Cloretazine(R) (VNP40101M) as a single agent in small cell lung cancer is also underway. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating VNP40541, a hypoxia-selective compound, and hydrazone compounds. The Company also is seeking development partners for TAPET(R), its modified Salmonella vector used to deliver anticancer agents directly to tumors. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com.

[Ackergaul]

Antwort auf Beitrag Nr.: 29.820.735 von Mihalis am 11.06.07 14:29:12

das sind im "eigentlichen" die (guten) alten Daten soweit ich dass interpretieren kann. Wohl vom CLI-033 Trial...

Bin mir jetzt aus dem Stehgreif nicht so sicher, ob die Sterblichkeitsrate von 20 % vorher schon beschrieben war. Zumindest kann man auch daran ein wenig ableiten, dass es in der Phase III vermutlich mehr an ara-c liegt.

Ich habe schon erst gedacht, die Meldung ist draussen, dass alle Patienten rekutriert worden sind... müssen wir wohl noch etwa 6 Wochen warten.

[Ackergaul]

Antwort auf Beitrag Nr.: 29.822.244 von Ackergaul am 11.06.07 15:31:15

Wie schon vermutet: Daten stammen aus dem CLI-033 Trial (Elderly AML...)

View abstract data


AuthorVey, N. , Marseille cedex 9, Paoli-Calmettes France

Co-author(s) Rizzieri, D. , Durham, NC, Duke University
Karp, J. , Baltimore, MD, Johns Hopkins University
Karsten, V. , New Haven, CT, Vion Pharmaceuticals
Cahill, A. , New Haven, CT, Vion Pharmaceuticals
Giles, F. , Houston, TX, UT MD Anderson Dept of Leukemia

Topic19. Acute myeloid leukemia - clinical

KeywordsAcute myeloid leukemia,Cytogenetics,Elderly,


Background: Outcomes for elderly patients with AML are poor, and it has been shown that elderly patients with unfavorable cytogenetics have a particularly poor prognosis. Additionally, a large number of these patients are considered unfit for intensive chemotherapy due to coexisting comorbidities, and are given best supportive care or low-dose AraC. However, no complete remissions are observed with this treatment and median overall survival is approximately 1 month (Burnett et al. Cancer 2007). Patients with unfavorable cytogenetics who do receive cytotoxic induction treatment achieve complete response rates between 23-33% with very low 5-year survival rates (2-4%) (Grimwade et al Blood 2001, Rowe et al Blood 2004, Farag et al Blood 2006, Buechner et al JCO 2006).
Methods: We present a subset analysis of patients with unfavorable cytogenetics in a Phase II study of Cloretazine® as a single agent (Vion Study CLI-033). Cloretazine® is a new alkylating agent that causes DNA cross-links and cell death. The study was designed for untreated patients with AML or high-risk MDS over the age of 60. Treatment consisted of Cloretazine® (VNP40101M) 600 mg/m2 administered as a short IV infusion on day 1 (second cycle allowed) and an additional 400 mg/m2 as consolidation for responders (CR or CRp). The primary endpoint was overall response (CR or CRp). Overall survival and relapse-free survival were also analyzed.
Results: The study treated 128 patients of age 60 or older. Fifty-eight patients (45%) had unfavorable cytogenetics (-7, del5q, abnl11q, abnl9q, abnl20q, abnl13q, complex (>/= 3 abnormalities)). Of these 58 patients, 28 (48%) had secondary AML, 19 (33%) had de novo AML and 11 (19%) had high-risk MDS. Twenty-three (40%) patients in the unfavorable group had a complex karyotype. The response rate in patients with unfavorable cytogenetics was 26% (15/58). Response by diagnosis: 53% in de novo AML, 27% in MDS and 7% in secondary AML. Median overall survival in patients with unfavorable cytogenetics was 3 months (range 0.1-28). In patients achieving CR or CRp, median overall survival was 5 months (range 2-28) and relapse-free survival was 3.5 months (range 1-20). In non-responders, overall survival was 2 months (range 0.1-9). Twelve (21%) patients died within 30 days of receiving induction treatment.
Conclusions: Cloretazine® has the ability to induce remissions in elderly AML patients with unfavorable cytogenetics. Survival in this group is improved compared to that reported for supportive care or low dose AraC. Cloretazine® may provide an important treatment option for poor prognosis patients with AML.

[Ackergaul]

Antwort auf Beitrag Nr.: 29.825.367 von Ackergaul am 11.06.07 17:18:15

nur kurz, dass dazugehörige Poster:

http://www.vionpharm.com/pdf/EHA07.pdf

[Ackergaul]

Vielleicht kann Kessman morgen noch ein wenig Licht ins Dunkle bringen. Denke aber nicht, dass neue Infos vom CLI-037 auftauchen. Nichts-desto-trotz kann ich mir momentan kaum vorstellen, dass die Daten des CLI-037 (wenn sie mal ausgewertet sind) irgendwie positiv vom Markt aufgenommen werden... Außer dass das DSMB nun doch wieder eine "Freigabe zum Weitermachen" vorschlägt oder der schwarze Peter an ara-c festgemacht wird!

Vion Pharmaceuticals to Hold Annual Meeting of StockholdersMonday June 25, 8:00 am ET

NEW HAVEN, Conn., June 25 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION - News) today announced that the Company's Annual Meeting of Stockholders will be held Tuesday, June 26, 2007 at The Stamford Marriott Hotel, 243 Tresser Boulevard, Stamford, Connecticut. The meeting will begin at 10:00 a.m. Eastern Time.

Vion's Chief Executive Officer, Alan Kessman, will make a presentation on the Company at the meeting. Slides from the presentation will be available on the Company's website, www.vionpharm.com, after 10:00 a.m. on June 26th.

...

[Ackergaul]

Antwort auf Beitrag Nr.: 30.307.056 von Ackergaul am 25.06.07 15:16:51

Anliegend die Zusammenfassung des Annual Meetings.
http://www.vionpharm.com/pdf/VionAnnualMeeting07.pdf

Cloretazine: Keine News zum angehaltenen CLI-037 Trial. CLI-043 läuft nach Plan. SCLC Daten O.K. bis gut.
Triapine: und gemcitabine bei pancreatic cancer median os 8-9 Monate
Sonstiges: Was mich noch wunderte, Vion baut noch aus (Fläche) und stellt bis Ende Dez. noch Leute ein...



Grüße

[Ackergaul]

Antwort auf Beitrag Nr.: 30.424.166 von Ackergaul am 01.07.07 11:23:38

Kurzfristig bin ich nach wie vor negativ zu Vion eingestellt. Kann mir - wie schon mehrfach erwähnt - nicht vorstellen, dass die bald ausgewerteten Daten des CLI-037 Trials positiven Einfluss auf den Kurs haben werden. Wahrscheinlicher ist das Gegenteil... Aber Vion ist nach wie vor aus meiner Sicht interessant. Cloretazine hat noch verschiedene Möhlichkeiten, wie z.B.:

Neuro Oncol. 2007 Jul;9(3):240-4. Epub 2007 May 23.
Activity of VNP40101M (Cloretazine) in the treatment of CNS tumor xenografts in athymic mice.
Badruddoja MA, Keir ST, King I, Zeidner J, Vredenburgh JJ, Muhlbaier LH, Bigner DD, Friedman HS.
Preston Robert Tisch Brain Tumor Center at Duke, Room 047 Baker House, South Hospital, Trent Drive, Duke University Medical Center, Durham, NC 27710, USA. [e-mail].

VNP40101M, or 1,2-bis(methylsulfonyl)-1-(2-choloroethyl)-2-(methylamino)carbonylhydrazine (Cloretazine), is a bifunctional prodrug that belongs to a class of DNA-modifying agents-the sulfonylhydrazines-that has been synthesized and been shown to have activity against a wide spectrum of xenografts. The current study was designed to assess the activity of VNP40101M administered at a dose of 18 mg/kg daily for five days against a panel of human adult and pediatric CNS tumors growing subcutaneously or intracranially in athymic nude mice. The results demonstrated statistically significant (p < 0.05) growth delays of 15.0, 8.3, 51.0, 60+, 60+, and 60+ days in subcutaneous xenografts derived from childhood glioblastoma multiforme (D-456 MG), childhood ependymoma (D-528 EP and D-612 EP), childhood medulloblastoma (D-425 MED), and adult malignant glioma (D-245 MG and D-54 MG), respectively, with corresponding tumor regressions in 10 of 10, 4 of 10, 8 of 10, 9 of 10, 9 of 10, and 10 of 10 treated mice, respectively. Delayed toxicity was seen more than 60 days after treatment, with 23 deaths in 100 treated animals, despite a median weight loss of only 0.06%. In mice bearing intracranial D-245 MG xenografts, treatment with VNP40101M at a dose of 18 mg/kg daily for five days produced a 50% increase in median survival compared with controls. Additional experiments conducted against subcutaneous D-245 MG xenografts by using reduced doses of 13.5 or 9.0 mg/kg daily for five days demonstrated tumor growth delays of 82.2 and 53.5 days, with corresponding tumor regressions in 8 of 9 and 9 of 10 treated mice, respectively (all values, p < 0.001), with one toxic death. These findings suggest that VNP40101M is active in the treatment of a wide range of human central nervous system tumors and warrants translation to the clinic.


Kurzfristig denke ich wird nur die Mitteilung, dass der CLI-043 Trial vollständig ist für Auftrieb sorgen. Ende des Jahres, wenn die Auswertung erfolgt, kann (oder sollte?) man sich spätestens wieder mit Vion beschäftigen...

[Ackergaul]

Antwort auf Beitrag Nr.: 30.712.428 von Ackergaul am 16.07.07 16:07:48

es geht mir hier nicht um den gestrigen Kursanstieg. Vielmehr um das Volumen, dass um ein vielfaches höher war, als in den vergangenen Handelstagen:

Date      Open High Low  Clos Volume    Adj Close* 

18-Jul-07 1.01 1.18 1.01 1.14 1,352,600 1.14 

17-Jul-07 1.01 1.02 0.98 1.01   554,900 1.01 

16-Jul-07 1.04 1.06 1.01 1.01   153,600 1.01 

13-Jul-07 1.02 1.06 1.00 1.04   276,200 1.04 

12-Jul-07 1.07 1.08 0.99 1.02   610,000 1.02 

11-Jul-07 1.06 1.08 1.05 1.08   229,300 1.08 

10-Jul-07 1.07 1.10 1.05 1.05   202,900 1.05 

09-Jul-07 1.10 1.12 1.08 1.08   190,100 1.08 

06-Jul-07 1.10 1.11 1.08 1.11   357,400 1.11 

05-Jul-07 1.09 1.11 1.07 1.09   228,900 1.09 

03-Jul-07 1.11 1.12 1.07 1.09   467,200 1.09 

02-Jul-07 1.09 1.12 1.08 1.11   217,500 1.11 

29-Jun-07 1.10 1.13 1.08 1.08   190,500 1.08 

28-Jun-07 1.10 1.13 1.10 1.11   189,000 1.11 

27-Jun-07 1.09 1.13 1.09 1.11   307,600 1.11 

26-Jun-07 1.14 1.16 1.10 1.11   244,800 1.11 

[Klausken]

Hier herrscht ja wirklich reges Interesse an diesem Wert, kann man ei dem Verlauf auch verstehen...



http://www.worldofinvestment.com/wkn/902972/

Ob es hier so schnell nochmal hochgehen wird halte ich für fraglich!

[Ackergaul]

Antwort auf Beitrag Nr.: 31.096.598 von Klausken am 09.08.07 15:35:34

Moin Klausken,

dass trifft sich gut, wollte eh heute ein kleines Update zu Vion bringen (nach den 2. Quartal Zahlen). Die nächsten Monate (bis Dezember) werden voraussichtlich genauso ruhig um Vion - zumindest aus meiner Sicht.

- Unbeobachtet und ohne eine eigene Pressemitteilung wurde gemeldet, dass der CLI-043 Trial komplettiert wurde. Zur ASH im Dezember will man Ergebnisse bekannt geben und Anfang 2008 mit der FDA ein NDA arrangieren. Dies beruht dann nur auf dem aktuellen Phase II CLI-043 Trial. Ob dies der FDA reicht? Gut, Daten vom Phase II CLI-033 Trial können auch vorgelegt werden und Vion beruft sich auch auf die Tatsache, dass die FDA bereits mehrere Male ein Regulatory Approval auf Grund von Response Daten erteilt hat. Dennoch ein wenig skeptisch bin ich hier...
- Kommen wir zum eigentlichen Sorgenkind und dem Grund warum Vions Kurs sich nicht mehr bei 2, sondern unter 1 $ befindet: CLI-037. Die Daten sind ausgewertet – sehr schön. Aber das war’s auch an guten Meldungen, denn jetzt wird mit dem DSMB erst gesprochen, dann mit der FDA und hiernach mit weiteren Behörden… zum Jahresende, möglicherweise, aber nur ungefähr weiß man genaueres… Natürlich kann Vion das nicht verkürzen, hier sind die Hände gebunden. Ich rechne NICHT mit einem guten Ausgang, sprich dass der Trial weitergeführt wird oder angepasst und anschliessend fortgesetzt wird. Eher glaube ich, dass eine neue Phase III gestartet wird.
- In Erinnerung sollte man sich aber auch noch die Phase II Daten in SCLC rufen. Cloretazine bewies hier Wirkung!
- Zur finanziellen Situation. Dass die Verluste im 1. Halbjahr 2007 höher als 2006 waren, lag eindeutig an den Phase II und III Studien. Die Kosten sind auch nicht beunruhigend gewachsen. 74.4 Mil. $ an Cash und Sonstigen sind noch vorhanden. 16,8 Mil. “kostete” dass erste Halbjahr, damit kann überschlagen werden, dass das Geld noch für etwa 2 Jahre reichen sollte...

Optimistisch bin ich für die nächsten Monat nicht. Es gibt halt wenig kommende (kurstreibende) Ereignisse. Zu Triapine werde ich später noch ein Wort verlieren, Tapet ist schon jahrelang Tod (Karteileiche) und der Rest der Pipeline einfach noch zu weit weg um Interesse zu wecken.


Grüße

Nur mal am Rande: Wird alleine Cloretazine in frontline AML (älter 60 Jahre) also CLI-043 zugelassen so schätze ich, dass 2010 mehr als 5.000 Patienten behandelt werden könnten (AML und off label High Risk MDS). Bei geschätzt durschnitlich 25.000 $ Behandlungskosten würden dann trotz HK und ca. 80 bis 90 Mio $ an Vertrieb, Verwaltung, R$D noch ein paar Dollar über bleiben. Und Cloretazine bei relapsed AML ist NICHT Tod (CLI-037 vielleicht) und bei SCLC auch noch am laufen.

[Ackergaul]

Hoffnungsschimmer Triapine in Bauchspeicheldrüsen Krebs?

Auf der Jahreshauptversammlung Vions wurden die survival Daten von Triapine & gemcitabine herausgehoben. Der Median beträgt hier etwa 8-9 Monate, zum Vergleich die Pfizer Kombination von axitinib & gemcitabine wurde mit 6,9 Monaten angegeben. Jedoch sollte hier auch auf die objective response Werte geschaut werden: 15 % „lediglich“ mit PR, jedoch sind wieder die 60 % stable disease hervorzuheben… Diese Behandlung (Triapine & gemcitabine) wurde ursprünglich aus Mangel an Anti Tumor Aktivität eingestellt! Wie unten in den Pfizer News zu lesen war, hatte gemcitabine alleine 5,6 Monate erreicht. Jedoch ist Vorsicht geboten, die response Werte würde ich als relativ mager bezeichnen und demnach können die survival Daten „Zufall“ sein. Triapine kann man mehr als einen Deckel in der Krebsbekämpfung sehen, der einen passenden Topf beötigt...

ABSTRACT
Background: Triapine® is a small molecule that inhibits ribonucleotide reductase at a site distinct from gemcitabine (gem). In tumor cell lines, pre-exposure to Triapine® enhances gem uptake and DNA incorporation, and yields synergistic cytotoxicity. A phase I trial of Triapine® + gem showed that the combination was well-tolerated and produced Triapine® serum concentrations sufficient to modulate gem activity in vitro (Ca Chemother Pharmacol, 2004). Methods: We conducted a phase II trial of Triapine® + gem in advanced pancreatic cancer pts at 7 centers. Eligible pts were untreated, had measurable disease and ECOG PS 0-2. Triapine® was given by 4-hr infusion followed by gem 1000 mg/m2 on days 1, 8, and 15 of a 4-week schedule. Since preclinical studies showed longer exposure of Triapine® maximized synergy between the agents, the protocol was amended to administer Triapine® over 24 hrs continuous infusion (CI) prior to gem. Pts were assessed for response q 2 cycles and retreated to progression or toxicity. Results: Sixty pts (median age 62, range 37-88) were treated with Triapine® by 4-hr infusion (median 4 cycles, range 1-18). Pt characteristics included M:F 39/21; PS 0/1/2= 25(42%)/ 34(57%)/1(2%); metastatic/locally advanced 72/28%. Eight (15%) patients achieved PR; and 32 (60%) had stable disease. Median survival was 8 mos; 13% are alive at 1 yr. The next 6 pts (median age 54, range 50-69, M/F: 3/3) received Triapine® at a fixed dose of 400mg CI over 24 hrs + gem. Two pts were evaluable for response; 1 pt had PD, 1 pt is on treatment after 14 cycles. Due to excessive myelosuppression the dose of Triapine® CI was reduced to 105 mg/m2 over 24 hrs. Of 7 pts (median age 60, range 34-73) treated, 2 had PD, 1 was unevaluable, and 4 remain on tx. Triapine® toxicity included hypotension, hypoxia, rash and dyspnea in < 10% of pts. In the 2 CI groups (N=13), the only toxicity attributed to Triapine® was excessive myelosuppression, requiring gem dose reduction in all pts. Conclusions: Triapine® + gem shows activity in pancreatic cancer. As predicted by preclinical studies, prolonged exposure (CI) enhances biological effect of Triapine® + gem evidenced by increased myelosuppression without additional toxicities. Further studies are warranted to define the optimal dose of Triapine® CI with gem.

http://www.streetinsider.com/Basic+Content/Pfizer's+(PFE)+A…
Pfizer's (PFE) Axitinib Prolonged Overall Survival in Advanced Pancreatic Cancer When Combined with Standard of Care Chemotherapy
06-04-2007 09:17:18 AM
Pfizer (NYSE: PFE) announced that axitinib (AG-013736), an investigational oral, selective inhibitor of VEGFR 1, 2,3 (vascular endothelial growth factor receptors 1, 2, 3) combined with gemcitabine showed a trend towards prolonged overall survival (OS) in patients with advanced pancreatic cancer, compared with gemcitabine alone, according to preliminary data from a randomized Phase II trial.
Results from a randomized Phase II study of 103 previously untreated patients with advanced pancreatic cancer demonstrated median overall survival with axitinib in combination with gemcitabine of 6.9 months compared with 5.6 months with gemcitabine alone. Axitinib combined with gemcitabine reduced the risk of death - by 26% compared to gemcitabine alone.
...

[Ackergaul]

Die ASH steht an und Vion ist dabei. Am Montag gibts noch ein Conference Call.

Obwohl Cloretazine nach dem im Spät Sommer schlimmen Ergebnis (Phase III ist angehalten - erhöhte Sterblichkeitsrate im Cloretazine-Arm), als Halb Tot angesehen werden kann, kann es interessante News geben. Die Cloretazine Phase II (ältere AML Patienten) Ergebnisse stehen auch noch an - dort gab es bzgl. Sterblichkeitsrate keine bad news...


Grüße

[Ackergaul]

Hallo,

hier die Zusammenfassung:

--> 28 patients (35%) achieved complete remission, confirming results of a previous Phase II study

Mylotarg wurde 2000 in AML zugelassen auf Grund einer response rate von 30% (aus mehreren Phase II Ergebnissen)


--> The majority (93%) of patients achieved a remission with a singledose of VNP40101M


--> The induction death rate within 30 days and 42 days of first treatment with VNP40101M is 15% and 24%, respectively

Expected Outcomes in AML Therapy (ECOG Experience 1976-1994)
Age (yrs) - CR rates (%) - Induction deaths (%) - Drug resistance (%)
>=70 - 35 - 39 - 30 (39 % Induction Death!)


--> Serious non-hematologic adverse events (>= grade 3) considered at least possibly related to treatment occurred in 11 patients (14%)


--> The majority (90%) of older patients with AML in this trial had multiple poor risk factors


Die Ergebnisse sind in Ordnung, aber die Tatsache, dass der Vorgänger Trial (CLI-033) ein besseres Ergebnis geliefert hat:
Subgroup analysis showed significant activity in 54 elderly patients with de novo AML with 24 patients (45%) achieving a complete response (CR) or CRp (CI: 30.9;58.6).

Hier waren die Patienten "Risiko" Faktoren ein wenig besser, aber wir haben eine Differenz von 10 % zum jetzigen Trial! Dennoch: Die Vorgaben dieses Trials waren, dass 22 Patienten eine CR oder CRp erreichen - dass wurde mit 28 Patienten nun überboten.

Der Bericht im ganzen:
http://www.vionpharm.com/pdf/ASH07-043.pdf


Wer ein wenig risikofreudig ist...

Mal sehen wie die US Börse später darauf reagiert. Dass Conference Call steht heute noch an und könnte viel Licht ins Dunkel bringen!


Grüße

[Andrija]

Antwort auf Beitrag Nr.: 32.711.845 von Ackergaul am 10.12.07 10:43:17

Wow, als Tiger gestartet und als Bettvorleger geendet. War wohl nicht so doll die Konferenz?

[Ackergaul]

Antwort auf Beitrag Nr.: 32.720.798 von Andrija am 10.12.07 22:30:22

mal wieder unschön... NICHTS KONKRETES, aber davon vieles...

- Partnerschaftsmeldungen zu Cloretazine: möglich bis wahrscheinlich. Wann, wie , wer und und und unklar. Es deutet sich aber anscheinend eine Partnerschaft mit einem "Europäer" an, wohl auch gleichbedeutend mit einem MAA zu Cloretazine in Europa.
- immer noch keine Infos zum angehaltenen Phase III Trial
- Analysten schienen sehr zurückhaltend und wenig interessiert zu sein - was mir aber wurscht ist

Dass solche (recht guten) Ergebnisse (Phase II: de novo poor-risk AML der ASH) noch im Minus enden, ist meiner Ansicht aber der blanke Hohn!
Ich denke erst, wenn eine Partnerschaftsmeldung gemeldet wird (Vertrauensbeweis) oder dass NDA zur Phase II Anfang 2008 beantragt wird oder endlich Infos zur angehaltenen Phase III kommen wird Vion wieder über einen Dollar stehen...


Grüße

[Andrija]

Antwort auf Beitrag Nr.: 32.722.638 von Ackergaul am 11.12.07 09:05:36

und weiter richtig abwärts. Mich hat es gestern ja in den Fingern gejuckt, gut das ich ruhig geblieben bin. Gibt es einen Grund für den weiteren Absturz? Das Chance/Risikoverhältnis erscheint mir aufgrund Deiner Recherchen bei dem Kursniveau ansonsten gut zu sein.
Gruß Andrija

[Ackergaul]

Antwort auf Beitrag Nr.: 32.736.518 von Andrija am 12.12.07 11:11:28

Tja, ärgerlich ist, wenn es ein CC gibt und dann keine echten Neuigkeiten, sondern nur dass ASH Ergebnis angepriesen wird.

Als Problem sehe ich momentan nur die Phase III (Cloretazine in fist-relapse AML). Der Trial ist nach wie vor gestoppt, auf Grund einer erhöhten Sterblichkeitsrate. Daten gibt es hierzu noch nicht - leider... Die Phase II hat dies jedoch nicht bestätigt, allerdings wie wird die FDA später reagieren und genau dass könnte dass Problem sein: Unsicherheiten!
Cloretazine wird noch bei SCLC in einer Phase II getestet, der Rest der Vion pipeline ist eher uninteressant bishin schlecht!

Leider ist schwer zu sagen, ob alles weiß oder schwarz momentan bei Vion ist. Tendiere aber dazu, dass die 1- Dollar Marke im 1.Q 2008 wieder geknackt werden sollte: mit der Gefahr, dass die Phase III komplett in den Müllkorb wandert. Jedoch wie weit solls noch runtergehen? 0,50$?



Grüße

[Andrija]

Antwort auf Beitrag Nr.: 32.743.327 von Ackergaul am 12.12.07 18:58:58

Ich habe mir gestern mal eine Spielerposition von 1.600 Stück gegönnt. Auf dem Niveau abseits zu stehen, erschien mir dann doch etwas zu langweilig. Ich nehme an, Du bist nach wie vor drin?

[Ackergaul]

Drücken wir uns mal so aus:
Vion wird wohl kein positives Ende mehr für mich haben. Bin etwa seit 1,60 $ mit drin, bis auf die "kurz darauf" Höhen von 2,20 $ und ohne Stop geradewegs...
Mir war bewusst, dass der längerfristige zeitraum noch viele Schmerzen mit sich bringt. Aber da ich vom Grundtyp darauf ausgerichtet bin, muss man ab und an dadurch. Seltsamerweise habe ich mehr Erfolg mit den kurzfristigen Sachen gehabt...

Naja wie auch immer - zumindest auch Dir viel Glück! Ich werde den Vion Wecker mal wieder auf Anfang 2008 stellen und dann mal wieder schauen.


Grüße

[Andrija]

Antwort auf Beitrag Nr.: 32.768.641 von Ackergaul am 14.12.07 18:13:58

Hallo Ackergaul, na nun rauschen wir beiden gemeinsam in den Orkus. Kein Ahnung welcher Marktwert ohne Cloretazine VION beizumessen ist. Gut 40 Mio. $ wohl eher nicht.
Gruß Andrija

[Ackergaul]

Antwort auf Beitrag Nr.: 32.881.877 von Andrija am 27.12.07 19:26:22

Ohne Cloretazine sollte der Marktwert sich nahe 0 befinden... Die Pipeline besteht nur noch aus Cloretazine und Triapine, wobei ich bei Triapine nicht viele Hoffnungen habe.

Cloretazine hat Wirksamkeit bewiesen, allerdings mit erhöhten Nebenwirkungen. Seit der ASH sehe ich eigentlich positiver, obwohl die letzte Phase II nicht ganz an den guten Vorgängerwerten (response) herankam.
Auf der ASH hatte die Konkurenz zudem leider einen guten Auftritt:
Clorofabine (ehemals von Bioenvision) hatte gute Ergebnisse bekannt gegeben, allerdings bei leichter zu behandelnden AML Patienten.


Grüße

[Ackergaul]

Das neue Börsenjahr startet für mich ganz gut... Gestern ISIS mit dem Mipo Deal, heute sollte Vion in Bewegung geraten:

Vion says FDA lifts clinical hold on cancer drug trial

Jan 8 (Reuters) - Vion Pharmaceuticals Inc (VION.O: Quote, Profile, Research) said the U.S. Food and Drug Administration lifted the clinical hold on the late-stage trial of the company's lead anti-cancer drug, Cloretazine.

The company said an agreement was reached with the FDA on modifications to the trial, which had been suspended in May of last year after a review of mortalities.

The amended trial will have a lower dose of the drug, and will recommence after the company submits more data, called a special protocol assessment, that contains the modifications to the FDA. (Reporting by Varsha Tickoo in Bangalore; Editing by Bernard Orr)

[Andrija]

Kurs entwickelt sich weiter saumäßig