PARS -70% auf 1,04$was ist da los???? - 500 Beiträge pro Seite

[Bauernpizza]

Pharmos Corporation ????

[stfan]

scheint so, als ob deren zahlen irgendwie, naja sagen wir mies aussehen werden ?

[stfan]

nö, viel schlimmer... steht aber alles in den news.

[XTrack]

Pharmos Announces Results from its Pivotal Phase III Trial of Dexanabinol for Severe Traumatic Brain Injury



Dexanabinol did not demonstrate efficacy
ISELIN, N.J., Dec. 20 /PRNewswire-FirstCall/ -- Pharmos Corporation (Nasdaq: PARS) announced today top line results of its pivotal Phase III trial of dexanabinol to treat severe traumatic brain injury (TBI). Dexanabinol did not demonstrate efficacy as measured by the primary clinical outcome endpoint, the Extended Glasgow Outcome Scale (GOSE). The double-blind, randomized, placebo-controlled trial was conducted in 86 trauma centers in 15 countries. In the 861 patient trial, 846 patients were available for analysis, 428 treated with dexanabinol and 418 treated with placebo. The randomization provided well-balanced groups for this study. While efficacy was not established, the trial demonstrated an excellent safety profile with no evidence of excess side effects in the dexanabinol-treated patients. Not all secondary endpoints have been analyzed; however, no differences were observed in mortality or in analysis of subgroups in the trial.

Dr. Haim Aviv, Chairman and CEO of Pharmos, said, "We are very disappointed and frankly somewhat perplexed that we did not observe any neuroprotective effect of dexanabinol in TBI. This trial was one of the largest ever completed in TBI. TBI is a severe injury of the most complex organ in the body and involves a patient population with high heterogeneity. It is therefore a very difficult indication to study, but we believe this study was performed according to the highest scientific standards and included important innovative aspects in the design and analysis aimed at improving the quality of the study. In the next few weeks, we will carefully analyze the results of this trial before making final decisions about our future plans, but it is unlikely that we will continue to develop dexanabinol for TBI. We plan, however, to continue developing dexanabinol for cognitive impairment in cardiac surgery, and we also remain committed to developing a drug candidate for pain."

Dr. Andrew Maas, Chairman of the European Brain Injury Consortium and Chairman of the Steering Committee of the study, said, "This study has great value from a scientific perspective. The Pharmos TBI trial included many innovative aspects in the design and was executed according to the highest scientific standards. The Steering Committee will work closely with the Company to analyze the data from the trial in order to garner scientific and medical information that will be valuable in treating TBI patients."

Dr. Gad Riesenfeld, President and COO of Pharmos, said, "We all share the disappointment in the results for TBI. However, we will continue to analyze the results of the Phase II CABG trial of dexanabinol and are committed to continuing that program. In addition, we expect to initiate clinical studies of our lead CB2-selective drug candidate, PRS-211,375, during the first half of 2005 for a pain indication. This compound and others in the preclinical pipeline have demonstrated very positive results in a range of pain and autoimmune disease animal models. We believe that the pipeline represents significant potential value for the Company. We are fortunate to have what we believe are both the necessary resources to carry these programs forward and the experience necessary to develop drugs and shepherd them through the approval process."

The pivotal Phase III clinical trial of dexanabinol for TBI was a double- blind, randomized, placebo-controlled trial conducted in European, Israeli, Australian and U.S. trauma centers. To maximize the probability of detecting a clinical benefit to severe TBI patients and to ensure a common protocol for the multinational trial, the Clinical Plan was carefully designed in collaboration with a panel of worldwide TBI experts who were members of the European Brain Injury Consortium (EBIC) and the American Brain Injury Consortium (ABIC). Among the several inclusion criteria that had to be satisfied, a patient must have sustained a severe brain injury as judged by both a Glasgow Coma Score between 4 and 8 and by a CT scan showing brain parenchymal damage. In addition, a patient must have been administered the single dose of placebo or 150 mg of the drug within 6 hours of injury.

Patients were evaluated at 3 and 6 months according to the GOSE. Results of the trial were analyzed by grouping patients into three outcome bands according to their baseline prognosis which were based on seven independent prognostic indicators. For each prognostic band the GOSE scores were dichotomized to differentiate "favorable" and "unfavorable" outcome. The goal of the study was to observe at six months a statistically significant increase in the number of dexanabinol-treated patients achieving a favorable outcome when compared to the placebo group. The six-month outcome demonstrates an odds ratio of l.04 in favor of dexanabinol with a 95% confidence interval of 0.79 to 1.36 (p=0.78).

Pharmos recently announced the results of an exploratory Phase II study of dexanabinol as a preventative agent against post-surgical cognitive impairment in coronary artery bypass graft (CABG) surgery patients. The study provided evidence that dexanabinol may act as a neuroprotectant by preserving integrative and executive functions that may be the most affected by CABG surgery. The Company will study the data from both the CABG and TBI trials in order to determine the best path forward to develop the potential value of dexanabinol as a neuroprotectant.

Recent scientific research has increased awareness of the potential therapeutic role of agents acting on the human cannabinoid receptor systems. In addition to developing dexanabinol that does not bind to cannabinoid receptors, Pharmos is developing a class of cannabinoid receptor agonists that bind preferentially to CB2 cannabinoid receptors. CB2 cannabinoid receptors are found predominately in peripheral immune cells as compared to CB1 receptors found predominately in the central nervous system. The CB2 receptors may be involved in the modulation of numerous neuroinflammatory diseases and disorders. Preclinical testing of these compounds has shown their potential efficacy in the treatment of chronic pain conditions and neuroinflammatory autoimmune diseases. The low CB1 activity of these compounds minimizes potential psychotropic side effects. Pharmos expects to begin clinical testing of its lead CB2-selective synthetic cannabinoid, PRS 211,375, for the treatment of pain indications in 2005.

Pharmos management will host a conference call to discuss the results at 10:30 a.m. Eastern Time today, Monday, December 20, 2004. A live webcast of the conference call will be available at http://phx.corporate-ir.net/playerlink.zhtml?c=70702&s=wm&e=… and will be archived for a limited time afterwards.

Pharmos discovers and develops novel therapeutics to treat a range of indications, in particular, neurological and inflammation-based disorders. The Company recently completed a Phase IIa trial for its neuroprotective drug candidate, dexanabinol, a tricyclic dextrocannabinoid, as a treatment as a preventive agent against post-surgical cognitive impairment. Other compounds from Pharmos` proprietary synthetic cannabinoid library, primarily CB2- selective receptor agonist compounds, are being studied in pre-clinical programs targeting pain, multiple sclerosis, rheumatoid arthritis and other disorders.

Statements made in this press release related to the business outlook and future financial performance of the Company, to the prospective market penetration of its drug products, to the development and commercialization of the Company`s pipeline products and to the Company`s expectations in connection with any future event, condition, performance or other matter, are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties which may cause results to differ materially from those set forth in these statements. Additional economic, competitive, governmental, technological, marketing and other factors identified in Pharmos` filings with the Securities and Exchange Commission could affect such results.

SOURCE Pharmos Corporation
-0- 12/20/2004
/CONTACT: Gale Smith of Pharmos U.S., [phone], or Irit Kopelov of
Pharmos Israel, +011-972-8-940-9679; Investors: John Quirk, [phone],
Media: Cynthia Isaac, Ph.D., [phone], both of The Ruth Group, Inc.,
both for Pharmos Corporation /
/Web site: http://www.pharmoscorp.com /
(PARS)

CO: Pharmos Corporation
ST: New Jersey
IN: HEA MTC BIO
SU: SVY CCA

AL
-- NYM081 --
1624 12/20/200407:01 ESThttp://www.prnewswire.com

[Bauernpizza]

was meint ihr könnte man auf einen kleinen Zock vorbeischauen!?

[XTrack]

Hm, sieht ein bisschen riskant für nen Zock aus... habe mich kurz informiert und den Eindruck bekommen, dass auf Dexanabinol der Fokus lag und die Pipeline ansonsten recht wenig zu bieten hat. Oder habe ich etwas übersehen?

[XTrack]

Laut CBS Marketwatch hatten die aber letztes Quarter noch 60mio$ Cash bei 99mio shares outstanding

[Richy]

Wie sieht denn der US-Realtime-Kurs aus und wie kann ich an US_Realtimekurse kommen?

[Bauernpizza]

aktuell stehen wir bei 1,05$

[Bauernpizza]

das wären schnelle 10% gewesen!!!

[Maniatis]

Gleich gehts unter 1.

Ich staune, wie schnell manche auf so eine Nachricht reagieren... Schon 8 Mio Shares umgesetzt. Wahnsinn!

[Richy]

Brauche mal wieder das Kribbeln. Bin zu 82 Cent eingestiegen aktuell Bid. 84 zu ask:86..
Mal schauen, was passiert!

[Bauernpizza]

1,23$aktuell!!!Tief war 0,97$

[steinuel]

meines erachtens ist pharmos keinen einstieg wert, da das medikament absolut keine wirkung gezeigt hat und die verantwortlichen absolut ratlos sind. dazu eine dürftige pipeline. die müssen doch wieder bei null anfangen.

[Spindocter]

Bin am 6.1. zu 1,19 rein.

Wer ist hier noch investiert?

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[suicidecommando]

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Press Release Source: Pharmos Corporation


Pharmos Receives Milestone Payment From Bausch & Lomb for Zylet(TM) Commercial Launch
Sunday January 23, 10:36 am ET


ISELIN, N.J., Jan. 23 /PRNewswire-FirstCall/ -- Pharmos Corporation (Nasdaq: PARS - News) announced today that the Company has received a gross milestone payment of $12.1 million from Bausch & Lomb (NYSE: BOL - News), its former marketing partner for ophthalmology products. The milestone payment was triggered by Bausch & Lomb`s commercial launch of Zylet(TM), which was approved for marketing by the FDA on December 15, 2004. Zylet is part of the loteprednol etabonate business that Pharmos sold to Bausch & Lomb in 2001.
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Pharmos also noted that an additional milestone payment could be earned by the Company based on Bausch & Lomb sales of Zylet over the next two years. The maximum future payment is $10 million.

"We are very pleased that Zylet has been launched, and are looking forward to its successful market penetration," said Dr. Gad Riesenfeld, President and COO of Pharmos. "It is gratifying that our collaborative development of our loteprednol etabonate business with Bausch & Lomb that produced two earlier successful proprietary anti-inflammatory products, Lotemax and Alrex, has culminated in the commercialization of Zylet."

Dr. Haim Aviv, Chairman and CEO of Pharmos, commented, "This payment adds to our current strong cash position which we are carefully using in accordance with our updated 2005 business and R&D plans to carry forward our drug development programs in prevention of cognitive impairment following cardiac surgery, pain and additional indications from our platform technology of CB2- selective immunomodulation. We are also evaluating opportunities to acquire or license late stage drug candidates for our pipeline."

Zylet is a combination anti-inflammatory and antibiotic (0.5% loteprednol etabonate and 0.3% tobramycin) to treat steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of infection exists. Zylet is the third product containing loteprednol etabonate approved by the FDA. Lotemax® and Alrex® have been marketed since 1998 as a result of three previous NDA approvals. Zylet represents the final product resulting from the Company`s earlier collaboration with Bausch & Lomb.

Pharmos is entitled to a gross milestone payment of $12.1 million from which will be deducted payments to the owner of the patent covering the technology and other parties for other related expenses, of approximately $2.9 million. Accounting for these expenses results in a net cash benefit to the Company of about $9 million that provides additional cash reserves for the Company`s ongoing development and anticipated initiation of clinical trials in 2005 of its lead CB2-selective drug candidate, PRS-211,375.

Pharmos discovers and develops novel therapeutics to treat a range of indications, in particular, neurological and inflammation-based disorders. The Company recently completed a Phase IIa trial for its neuroprotective drug candidate, dexanabinol, from its tricyclic dextrocannabinoid platform technology, as a preventive agent against post-surgical cognitive impairment. Other compounds from Pharmos` proprietary synthetic cannabinoid library, primarily CB2-selective receptor agonist compounds, are in pre-clinical studies targeting pain, multiple sclerosis, rheumatoid arthritis and other


disorders. Clinical development in pain indications is expected to commence
during 2005.

Statements made in this press release related to the business outlook and future financial performance of the Company, to the prospective market penetration of its drug products, to the development and commercialization of the Company`s pipeline products and to the Company`s expectations in connection with any future event, condition, performance or other matter, are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties which may cause results to differ materially from those set forth in these statements. Additional economic, competitive, governmental, technological, marketing and other factors identified in Pharmos` filings with the Securities and Exchange Commission could affect such results.




--------------------------------------------------------------------------------
Source: Pharmos Corporation

[Spindocter]

BINGO!!!!

Bis 1,80$ geh ich mit.
Da mach ich dann Kasse.
Oder bei 1,79$.

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