Xenova 890281 Medikament in Phase III - USA z. Z. 9 - 10 $ bei uns 7,50 Euro !!! - 500 Beiträge pro Seite
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nciuht reinfallen..pushrerthread..von xenova gibt es 2 versch. aktiengattungen!!!
hfi.com vergleicht die adrs mit den in london gehandelten dingern, es gibt 2 versch wp - kennnummern und 2 versch. aktien - verhältnisse
also laßt euch von net verarschen
hfi.com vergleicht die adrs mit den in london gehandelten dingern, es gibt 2 versch wp - kennnummern und 2 versch. aktien - verhältnisse
also laßt euch von net verarschen
Hi toby,
Du hast Dir Xenova sicher nicht genau angesehen.
Sonst wäre Dir aufgefallen, daß der deutsche Kurs immer
wunderschön dem US-Kurs hinterherläuft.
De facto kannst Du Dir morgens schon Deine bis zum Abend
zu erwartenden Gewinne ausrechnen.
ich habe die letzten Tage super damit verdient, also laß
den anderen doch auch die Chance auf einen tollen Erfolg.
Die "richtigen" Aktien sind übrigens die hier geposteten
890281, und die ADR`s mit der Nummer 890282 hängen sehr
wohl eng damit zusammen.
Allen Neu-Xenovanern viel Erfolg,
PI
Du hast Dir Xenova sicher nicht genau angesehen.
Sonst wäre Dir aufgefallen, daß der deutsche Kurs immer
wunderschön dem US-Kurs hinterherläuft.
De facto kannst Du Dir morgens schon Deine bis zum Abend
zu erwartenden Gewinne ausrechnen.
ich habe die letzten Tage super damit verdient, also laß
den anderen doch auch die Chance auf einen tollen Erfolg.
Die "richtigen" Aktien sind übrigens die hier geposteten
890281, und die ADR`s mit der Nummer 890282 hängen sehr
wohl eng damit zusammen.
Allen Neu-Xenovanern viel Erfolg,
PI
stellung aktuell auf 8 1/4 dollar...war wohl nicht viel, oder??
Auch die Kollegen über dem großen Teich werden, nachdem
sie mit dem gewinne realisieren fertig sind, ihre Äugelein
richtig aufmachen, und die heutige Pressemitteilung zur
Kennnis nehmen, und ...schnel, schnell... XENOVA ordern.
Krebstherapie-Medikamente in Phase III! Diese Fakten sprechen
für sich. Und ganz genau deshalb geht XENOVA durch die Decke:
"Xenova Group plc Preliminary Results for the Year Ended 31 December 1999 And Successful Completion Phase IIa Study XR9576/Paclitaxel - to Enter Pivotal Phase III Studies
SLOUGH, England, March 7 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA; London: XEN) today announces its results for the year to 31 December 1999.
XR9576 To Enter Phase III Studies
-- XR9576 successfully completes Phase IIa PK study with paclitaxel
taxol); to enter pivotal Phase III studies in Q4 2000
Operational Highlights
-- Multi-drug resistance modulator XR9576 in Phase IIa studies with three commercially important cytotoxics
-- Cytotoxic XR5000 enters Phase II studies in four tumour types
-- Sale of Xenova Discovery business provides 1m pounds sterling (pounds)cash and retained rights
-- Sale of MetaXen assets, intellectual property rights retained
-- Next generation cytotoxic XR11576 enters preclinical development
-- Revised Scientific Advisory Board and appointment of new Research and Development Director
Financial Highlights
-- Placing plus exercise of Warrants raises 8.4m pounds (net)
-- Asset sales reduce cash burn with consideration received of 4.1m
pounds"
Quelle: REUTERS, nachzulesen bei finance.yahoo.com
Viel Erfolg weiterhin mit XENOVA !
PI
sie mit dem gewinne realisieren fertig sind, ihre Äugelein
richtig aufmachen, und die heutige Pressemitteilung zur
Kennnis nehmen, und ...schnel, schnell... XENOVA ordern.
Krebstherapie-Medikamente in Phase III! Diese Fakten sprechen
für sich. Und ganz genau deshalb geht XENOVA durch die Decke:
"Xenova Group plc Preliminary Results for the Year Ended 31 December 1999 And Successful Completion Phase IIa Study XR9576/Paclitaxel - to Enter Pivotal Phase III Studies
SLOUGH, England, March 7 /PRNewswire/ -- Xenova Group plc (Nasdaq: XNVA; London: XEN) today announces its results for the year to 31 December 1999.
XR9576 To Enter Phase III Studies
-- XR9576 successfully completes Phase IIa PK study with paclitaxel
taxol); to enter pivotal Phase III studies in Q4 2000
Operational Highlights
-- Multi-drug resistance modulator XR9576 in Phase IIa studies with three commercially important cytotoxics
-- Cytotoxic XR5000 enters Phase II studies in four tumour types
-- Sale of Xenova Discovery business provides 1m pounds sterling (pounds)cash and retained rights
-- Sale of MetaXen assets, intellectual property rights retained
-- Next generation cytotoxic XR11576 enters preclinical development
-- Revised Scientific Advisory Board and appointment of new Research and Development Director
Financial Highlights
-- Placing plus exercise of Warrants raises 8.4m pounds (net)
-- Asset sales reduce cash burn with consideration received of 4.1m
pounds"
Quelle: REUTERS, nachzulesen bei finance.yahoo.com
Viel Erfolg weiterhin mit XENOVA !
PI
Tja war wohl nix. Schon 16% Minus in den USA.
Xenova Group plc Preliminary Results for the Year Ended 31 December 1999 AndSuccessful Completion Phase IIa Study XR9576/Paclitaxel - to Enter Pivotal PhaseIII Studies
Tue Mar 07 02:09:00 EST 2000
SLOUGH, England, Mar 7, 2000 /
PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London: XEN) today announces its results for the year to 31 December 1999.
XR9576 To Enter Phase III Studies
-- XR9576 successfully completes Phase IIa PK study with paclitaxel
(taxol); to enter pivotal Phase III studies in Q4 2000
Operational Highlights
-- Multi-drug resistance modulator XR9576 in Phase IIa studies with three commercially important cytotoxics
-- Cytotoxic XR5000 enters Phase II studies in four tumour types
-- Sale of Xenova Discovery business provides 1m pounds sterling (pounds) cash and retained rights
-- Sale of MetaXen assets, intellectual property rights retained
-- Next generation cytotoxic XR11576 enters preclinical development
-- Revised Scientific Advisory Board and appointment of new Research and Development Director
Financial Highlights
-- Placing plus exercise of Warrants raises 8.4m pounds (net)
-- Asset sales reduce cash burn with consideration received of 4.1m
pounds
"The announcement today that XR9576 will enter Phase III pivotal studies is a
significant development and indicates the strength of the Group`s oncology
focus. We are encouraged by the potential of XR9576 in eliminating problems of
drug resistance in the treatment of cancer," said David Oxlade, Chief Executive
Officer of Xenova Group plc.
He continued: "On a broader note, 1999 was a year of transition for Xenova. We
entered 2000 with our two lead drug candidates near to completion of Phase II
trials and a broader and stronger preclinical pipeline. The Xenova Discovery and
MetaXen disposals have allowed us to focus the Group on higher value added
proprietary drug discovery and development and to substantially reduce cash
burn."
Chief Executive`s Review
Throughout 1999 Xenova successfully implemented the strategic objectives first
outlined to shareholders in mid 1998. With its focus on the discovery,
evaluation and development of novel drugs, primarily for cancer, the Directors
believe the Group to be well positioned to take advantage of future
opportunities.
The Group`s underlying strategy is to further develop its growing product
pipeline through active in-licensing and academic collaborations; to manage risk
through commercial partnering at the appropriate or optimal time for each
project; and to generate revenues through commercial partnering, with retained
market rights and royalties. The Group currently has two oncology-related
products in a total of 7 Phase II clinical trials and a substantial preclinical
portfolio. Completion of all Phase II trials for both products is anticipated in
2000.
The Group`s financial position was strengthened by a June 1999 placing, which
raised 1.8m pounds net of expenses, and the exercise of warrants issued in
connection with the September 1998 Placing and Open Offer. Exercise of warrants
realised a total of 6.6m pounds net. The sales of the Xenova Discovery and
MetaXen businesses realised a gain and have reduced the rate of cash burn. In
both cases, Xenova has retained valuable rights to intellectual property and to
certain potential future revenue flows arising from the businesses prior to the
disposals. It was today announced that a non-exclusive licence has been granted
to Exelixis Pharmaceuticals Inc to use certain software and databases developed
by MetaXen.
Product Development
The company commenced a total of 7 Phase II clinical trials in early 1999 with
its two most advanced drugs, XR9576 and XR5000.
XR9576 -- The Group announced today that the Phase IIa study involving XR9576
and paclitaxel (taxol) (one of the world`s largest selling cytotoxic drugs) in
ovarian cancer patients has been completed and that the positive interim
pharmacokinetic results have been confirmed in the full data set from the 12
patients in the study. The Directors expect that XR9576 will enter pivotal Phase
III studies in late 2000.
XR9576 is a compound which is being developed to restore the sensitivity of
multi-drug resistant cancer cells to specific anti-cancer drugs, by modulating
the action of the P-glycoprotein (P-gp) pump. Up to 90 per cent of cancer
patients are estimated to develop resistance to current anti-cancer drugs and
P-gp related multi-drug resistance is the most common form of this phenomenon.
The Directors are not aware of any approved drugs which are currently marketed
as P-gp modulators.
The Phase IIa iv programme for XR9576, which is being carried out at five
centres in both the US and Europe, is studying the effects of XR9576 in
combination with a variety of approved commercially and therapeutically
important cytotoxic drugs namely doxorubicin, paclitaxel and vinorelbine. These
drugs are approved for use in a number of tumour types such as breast and
ovarian. The purpose of the studies is to assess the degree of drug interaction,
if any, between XR9576 and the cytotoxic drug.
The Phase IIa study involving XR9576 and paclitaxel in 12 ovarian patients,
which has now been completed, confirmed the positive interim pharmacokinetic
results for this trial, which were announced in November 1999. The study shows
that paclitaxel can be administered at the full normal dose with XR9576 as a
single administration. The study was carried out at The Royal Surrey County
Hospital, Guildford, UK, in patients with second line ovarian cancer recurring
more than 6 months after previous treatment, who had previously been treated
with a variety of cytotoxic drugs, including paclitaxel and platinum drugs. A
number of patients in the study are continuing on therapy with XR9576 and
paclitaxel and these patients are expected to complete their treatment by mid
2000. The outcome of the study indicates that XR9576 was well tolerated when
administered with paclitaxel, and caused no significant drug interaction.
Patients received paclitaxel at the standard dose of 175mg/m squared, with a
single intravenous XR9576 dose of 150mg 2 hours prior to administration of
paclitaxel.
Investigational new drug (IND) approval was received in November 1999 and US
trials, in which XR9576 is being co-administered in conjunction with
vinorelbine, in up to 30 patients, are being carried out in conjunction with the
National Cancer Institute (NCI). The first patients have entered combination
treatment. Results from this study are expected to be available by mid 2000.
Recruitment is well advanced for the doxorubicin/XR9576 Phase IIa trial. The PK
data from this study are expected to be available shortly. The 12 patients in
this study should be able to continue for up to 6 cycles of treatment.
Phase I study results for the intravenous and oral administration of XR9576 were
presented at the May 1999 meeting of the American Society of Clinical
Oncologists, and demonstrated that XR9576, when given by either route, was well
tolerated at all doses and gave virtually complete inhibition of P-gp, as
measured in CD56+ cells. Data from these studies were used to select the dose
for the Phase II studies as a once-per-day treatment.
XR5000 -- Phase II clinical trials are also underway for XR5000, a topoisomerase
I and II inhibitor, at a number of European centres.
XR5000 is being developed as a novel cytotoxic for the treatment of common solid
tumours. It has the potential to inhibit the action of both topoisomerases I and
II, enzymes which are critically involved in the duplication of DNA during the
process of cell growth and division. In preclinical studies XR5000 has been
shown not to be susceptible to the main multi-drug resistance mechanisms. It has
also been shown to cross the blood-brain barrier, which the Directors believe
gives it a unique profile of action.
The Phase II open label efficacy studies are being conducted on patients
recruited into the pan-European, multi-centre trial by the European Organisation
for the Research and Treatment of Cancer (EORTC). Up to 25 patients may be
treated in each study, which is underway in each of four different tumour types
-- ovarian, colorectal, non-small cell lung and glioblastoma. Patients enrolled
in these studies may take multiple doses of XR5000 for up to six cycles of
therapy. The use of an ambulatory pump for drug delivery allows patients to be
treated on an out patient basis. The Directors expect preliminary data from
these studies to be available by mid 2000.
Pre-Clinical Development
The adoption of a novel, orally active, next generation cytotoxic topoisomerase
I and II inhibitor, XR11576, as a preclinical development candidate was
announced in November 1999. XR11576 is designed to have a different chemical
structure to XR5000, with an improvement in its clinical profile versus other
drugs, while retaining the benefits XR5000 potentially provides. The candidate
is currently undergoing full preclinical safety evaluation studies, and if these
evaluation studies are successfully completed, the Directors expect clinical
studies to begin before the end of 2000.
Research in the Plasminogen Activator Inhibitor-1 (PAI-1) collaboration with
Lilly, which targets the development of a new class of antithrombotic drugs
suitable for chronic use, is being conducted jointly by Xenova and Lilly.
Certain research work in connection with this collaboration was previously
carried out by MetaXen. As part of the transfer of staff and assets of MetaXen
to Exelixis in 1999, Xenova has retained all rights to milestones and royalties
due under this collaboration.
Preclinical research is also continuing with the goal of identifying drug lead
candidates which address the roles of multi-drug resistance protein (mrp) in
cancer and in asthma, and the role of PAI-1 in metastatic cancer.
Proof of principle for the method of action of PAI-1 in cancer was presented by
Xenova at the July 1999 meeting of the British Association for Cancer Research.
Lilly has been granted an option to acquire exclusive rights to develop and
commercialise PAI-1 inhibitors in cancer.
In February 2000 Xenova announced the formation of a collaborative research
agreement for the discovery and development of novel classes of telomerase
inhibitors with Professor Robert Newbold and his team at The Institute of Cancer
Genomics and Pharmacogenomics, Brunel University, Uxbridge, UK.
Management
To reflect the company`s oncology focus, the structure of Xenova`s Scientific
Advisory Board (SAB) was amended in May 1999. The new SAB, led by Professor Stan
Kaye, Head of the Cancer Research Campaign Department of Medical Oncology at the
University of Glasgow, Scotland, is composed of a number of leading oncology
professionals -- Professor Paul Workman, Director of the Cancer Research
Campaign Centre for the Cancer Therapeutics Institute of Cancer Research,
London, Professor Herbie Newell, Director of Cancer Therapeutics at the Cancer
Research Unit, the University of Newcastle upon Tyne, Professor Mike Waterfield,
Director of Research at the Ludwig Institute for Cancer Research at University
College, London and Professor Adrian Harris, Director of the Imperial Cancer
Research Fund Molecular Oncology Laboratories and Director of the ICRF Medical
Oncology Unit in Oxford, England. Professor Harris is also a non-executive
director of Xenova Group plc. Stephen B Howell, Professor of Medicine at the
University of California, San Diego, joined Xenova`s SAB in January 2000.
Following the decision of Dr Paul Bevan to step down from his executive role,
Dr. John Waterfall was appointed as Xenova`s Research and Development Director.
Dr. Waterfall joined Xenova from Hoffmann-La Roche, Nutley, New Jersey, USA,
where he was Divisional Vice President, Global Project Management. Dr. Bevan
remains as a non-executive director of the Company. In May 1999 Dr. Michael
Moore, who was formerly head of Xenova Discovery, was appointed Chief Scientific
Officer with special responsibility for thekVe director of Xenova Group plc,
Mr. Peter Gillett, a partner at audit and financial services firm Ernst & Young,
was appointed as a non-executive director in February 2000. Peter Gillett
currently chairs Xenova`s Audit Committee.
Outlook
Xenova intends to continue to fulfil its strategic objectives through a strategy
which includes the continuing discovery and development of novel drugs of high
commercial potential, where the Group creates and owns the intellectual property
involved and retains commercialisation rights to this intellectual property.
Under this strategy, commercialisation of the products of the Group`s research
may occur through partnering with major pharmaceutical companies at the optimal
point, having regard to the level of scientific and commercial risk and return
for each individual project. This may result in the Group taking products
through to completion of Phase III clinical trials in its core cancer area, and
may result in earlier stage partnering for products for other indications.
Financial Summary
Operating Performance
Turnover for the year was 2.7m pounds ($4.3m) (1998: 4.9m pounds ($7.8m)).
Receipts of 2.3m pounds ($3.7m) under the PAI-1 agreement with Lilly represent
recovery of research expenditure. 1998 PAI-1 receipts of 4.1m pounds ($6.8m)
included milestone payments from Lilly of 1.3m pounds ($2.2m) as well as the
recovery of research expenditure. Turnover in the six months to 31 December 1999
was 0.9m pounds ($1.4m) (1998: 1.9m pounds ($3.1m)), with the decrease primarily
attributable to the transfer in-house to Lilly of work in connection with the
ongoing Xenova/Lilly strategic cardiovascular research and development
programme.
Operating costs declined to 13.6m pounds ($22.0m) (1998: 19.5m pounds ($31.4m))
and comprised 11.3m pounds ($18.2m) (1998: 16.5m pounds ($26.6m)) of research
and development costs and 2.3m pounds ($3.7m) (1998: 3.0m pounds ($4.8m)) of
administrative expenses. The reduction in operating costs reflects the fall in
the headcount at 31 December 1999 to 57 (1998: 123) following the disposal of
the non core businesses and disposal of surplus leasehold property in the US and
UK. Research and development costs for continuing operations increased to 7.8m
pounds ($12.6m) (1998: 6.7m pounds ($10.8m)) reflecting further progress through
clinical trials by XR9576 and XR5000, both of which entered Phase II trials
during the course of 1999. Continuing administrative costs fell to 2.0m pounds
($3.2m) (1998: 2.2m pounds ($3.5m)). Operating loss for the year was 10.9m
pounds ($17.6m) (1998: 14.6m pounds ($23.6m)). Operating loss for the six months
to 31 December 1999 was 4.7m pounds ($7.6m) (1998: 7.8m pounds ($12.5m)).
Disposals
The sale of the majority of the assets of Xenova Discovery Limited to TerraGen
Diversity Inc was completed in April 1999. The sale resulted in total realised
and unrealised gain on disposal of 3.0m pounds ($4.8m). Xenova received a total
of 1.0m pounds cash during 1999 plus 1 million preferred voting shares in
TerraGen Diversity Inc, valued at 1.5m pounds equivalent to 6% of the current
issued share capital. An interest bearing loan note of 1.5m pounds was also
issued to Xenova by TerraGen Diversity Inc. After 24 months the loan note can be
converted into TerraGen equity at the option of either party, and is
automatically convertible at the end of 36 months, which would be equivalent to
a further 6% of the current issued share capital. There is an anti dilution
provision under which if there is a subsequent financing at a lower price then
the conversion price of the loan note will be similarly adjusted. In line with
the issued draft guidance from the Institute of Chartered Accountants in England
and Wales, entitled `The determination of realised profits and distributable
profits in the context of the Companies Act 1985`, the total profit on the
disposal of the Xenova Discovery business disclosed in the Half year and
Quarterly announcements has now been analysed into that which has been realised
and that which is unrealised. Of the total profit of 3.0m pounds, the realised
element of 0.8m pounds has been included in the profit and loss for the year and
the unrealised profit of 2.2m pounds has been taken to the Statement of Total
Recognised Gains and Losses.
The sale of certain of the assets of MetaXen, a San Francisco-based subsidiary,
to Exelixis was completed in July 1999. The sale resulted in a loss on disposal
of 0.5m pounds ($0.8m). Xenova received total cash of 0.1m pounds ($0.2m).
Treasury
Xenova raised a total of 8.4m pounds net ($13.5m) from the placing and exercise
of warrants in the year to 31 December 1999. In July 1999 Xenova made a private
placing of 2,150,038 shares at 85p raising 1.8m pounds ($2.9m). The exercise of
warrants linked to an October 1998 placing and open offer raised 6.6m pounds
($10.6m) in the year.
Capital expenditure during the year was 0.1m pounds ($0.2m) (1998: 2.2m pounds
($3.5m). Proceeds from disposals of tangible fixed assets were 0.2m pounds
($0.3m) (1998: pounds nil).
Net interest of 0.5m pounds ($0.9m) was earned in the year (1998: 0.7m pounds
($1.1m)). Cash and liquid resources at year end were 10.1m pounds ($16.3m)
(1998: 11.4m pounds ($18.4m)).
Called up shares at 31 December 1999 were 54,627,506. Following completion of
the warrant exercise programme in January 2000, shares in issue rose to
54,706,537 as at 3rd March 2000.
The directors do not recommend the payment of a dividend (1998: nil).
Safe Harbor Statement under the US Private Securities Litigation Reform Act of
1995: Some or all of the statements in this document that relate to future
plans, expectations, events, performances and the like are forward-looking
statements, as defined in the US Private Securities Litigation Reform Act of
1995. Actual results of events could differ materially from those described in
the forward-looking statements due to a variety of factors, including those set
forth in the Company`s filings with the US Securities and Exchange Commission.
Tue Mar 07 02:09:00 EST 2000
SLOUGH, England, Mar 7, 2000 /
PRNewswire via COMTEX/ -- Xenova Group plc (Nasdaq: XNVA; London: XEN) today announces its results for the year to 31 December 1999.
XR9576 To Enter Phase III Studies
-- XR9576 successfully completes Phase IIa PK study with paclitaxel
(taxol); to enter pivotal Phase III studies in Q4 2000
Operational Highlights
-- Multi-drug resistance modulator XR9576 in Phase IIa studies with three commercially important cytotoxics
-- Cytotoxic XR5000 enters Phase II studies in four tumour types
-- Sale of Xenova Discovery business provides 1m pounds sterling (pounds) cash and retained rights
-- Sale of MetaXen assets, intellectual property rights retained
-- Next generation cytotoxic XR11576 enters preclinical development
-- Revised Scientific Advisory Board and appointment of new Research and Development Director
Financial Highlights
-- Placing plus exercise of Warrants raises 8.4m pounds (net)
-- Asset sales reduce cash burn with consideration received of 4.1m
pounds
"The announcement today that XR9576 will enter Phase III pivotal studies is a
significant development and indicates the strength of the Group`s oncology
focus. We are encouraged by the potential of XR9576 in eliminating problems of
drug resistance in the treatment of cancer," said David Oxlade, Chief Executive
Officer of Xenova Group plc.
He continued: "On a broader note, 1999 was a year of transition for Xenova. We
entered 2000 with our two lead drug candidates near to completion of Phase II
trials and a broader and stronger preclinical pipeline. The Xenova Discovery and
MetaXen disposals have allowed us to focus the Group on higher value added
proprietary drug discovery and development and to substantially reduce cash
burn."
Chief Executive`s Review
Throughout 1999 Xenova successfully implemented the strategic objectives first
outlined to shareholders in mid 1998. With its focus on the discovery,
evaluation and development of novel drugs, primarily for cancer, the Directors
believe the Group to be well positioned to take advantage of future
opportunities.
The Group`s underlying strategy is to further develop its growing product
pipeline through active in-licensing and academic collaborations; to manage risk
through commercial partnering at the appropriate or optimal time for each
project; and to generate revenues through commercial partnering, with retained
market rights and royalties. The Group currently has two oncology-related
products in a total of 7 Phase II clinical trials and a substantial preclinical
portfolio. Completion of all Phase II trials for both products is anticipated in
2000.
The Group`s financial position was strengthened by a June 1999 placing, which
raised 1.8m pounds net of expenses, and the exercise of warrants issued in
connection with the September 1998 Placing and Open Offer. Exercise of warrants
realised a total of 6.6m pounds net. The sales of the Xenova Discovery and
MetaXen businesses realised a gain and have reduced the rate of cash burn. In
both cases, Xenova has retained valuable rights to intellectual property and to
certain potential future revenue flows arising from the businesses prior to the
disposals. It was today announced that a non-exclusive licence has been granted
to Exelixis Pharmaceuticals Inc to use certain software and databases developed
by MetaXen.
Product Development
The company commenced a total of 7 Phase II clinical trials in early 1999 with
its two most advanced drugs, XR9576 and XR5000.
XR9576 -- The Group announced today that the Phase IIa study involving XR9576
and paclitaxel (taxol) (one of the world`s largest selling cytotoxic drugs) in
ovarian cancer patients has been completed and that the positive interim
pharmacokinetic results have been confirmed in the full data set from the 12
patients in the study. The Directors expect that XR9576 will enter pivotal Phase
III studies in late 2000.
XR9576 is a compound which is being developed to restore the sensitivity of
multi-drug resistant cancer cells to specific anti-cancer drugs, by modulating
the action of the P-glycoprotein (P-gp) pump. Up to 90 per cent of cancer
patients are estimated to develop resistance to current anti-cancer drugs and
P-gp related multi-drug resistance is the most common form of this phenomenon.
The Directors are not aware of any approved drugs which are currently marketed
as P-gp modulators.
The Phase IIa iv programme for XR9576, which is being carried out at five
centres in both the US and Europe, is studying the effects of XR9576 in
combination with a variety of approved commercially and therapeutically
important cytotoxic drugs namely doxorubicin, paclitaxel and vinorelbine. These
drugs are approved for use in a number of tumour types such as breast and
ovarian. The purpose of the studies is to assess the degree of drug interaction,
if any, between XR9576 and the cytotoxic drug.
The Phase IIa study involving XR9576 and paclitaxel in 12 ovarian patients,
which has now been completed, confirmed the positive interim pharmacokinetic
results for this trial, which were announced in November 1999. The study shows
that paclitaxel can be administered at the full normal dose with XR9576 as a
single administration. The study was carried out at The Royal Surrey County
Hospital, Guildford, UK, in patients with second line ovarian cancer recurring
more than 6 months after previous treatment, who had previously been treated
with a variety of cytotoxic drugs, including paclitaxel and platinum drugs. A
number of patients in the study are continuing on therapy with XR9576 and
paclitaxel and these patients are expected to complete their treatment by mid
2000. The outcome of the study indicates that XR9576 was well tolerated when
administered with paclitaxel, and caused no significant drug interaction.
Patients received paclitaxel at the standard dose of 175mg/m squared, with a
single intravenous XR9576 dose of 150mg 2 hours prior to administration of
paclitaxel.
Investigational new drug (IND) approval was received in November 1999 and US
trials, in which XR9576 is being co-administered in conjunction with
vinorelbine, in up to 30 patients, are being carried out in conjunction with the
National Cancer Institute (NCI). The first patients have entered combination
treatment. Results from this study are expected to be available by mid 2000.
Recruitment is well advanced for the doxorubicin/XR9576 Phase IIa trial. The PK
data from this study are expected to be available shortly. The 12 patients in
this study should be able to continue for up to 6 cycles of treatment.
Phase I study results for the intravenous and oral administration of XR9576 were
presented at the May 1999 meeting of the American Society of Clinical
Oncologists, and demonstrated that XR9576, when given by either route, was well
tolerated at all doses and gave virtually complete inhibition of P-gp, as
measured in CD56+ cells. Data from these studies were used to select the dose
for the Phase II studies as a once-per-day treatment.
XR5000 -- Phase II clinical trials are also underway for XR5000, a topoisomerase
I and II inhibitor, at a number of European centres.
XR5000 is being developed as a novel cytotoxic for the treatment of common solid
tumours. It has the potential to inhibit the action of both topoisomerases I and
II, enzymes which are critically involved in the duplication of DNA during the
process of cell growth and division. In preclinical studies XR5000 has been
shown not to be susceptible to the main multi-drug resistance mechanisms. It has
also been shown to cross the blood-brain barrier, which the Directors believe
gives it a unique profile of action.
The Phase II open label efficacy studies are being conducted on patients
recruited into the pan-European, multi-centre trial by the European Organisation
for the Research and Treatment of Cancer (EORTC). Up to 25 patients may be
treated in each study, which is underway in each of four different tumour types
-- ovarian, colorectal, non-small cell lung and glioblastoma. Patients enrolled
in these studies may take multiple doses of XR5000 for up to six cycles of
therapy. The use of an ambulatory pump for drug delivery allows patients to be
treated on an out patient basis. The Directors expect preliminary data from
these studies to be available by mid 2000.
Pre-Clinical Development
The adoption of a novel, orally active, next generation cytotoxic topoisomerase
I and II inhibitor, XR11576, as a preclinical development candidate was
announced in November 1999. XR11576 is designed to have a different chemical
structure to XR5000, with an improvement in its clinical profile versus other
drugs, while retaining the benefits XR5000 potentially provides. The candidate
is currently undergoing full preclinical safety evaluation studies, and if these
evaluation studies are successfully completed, the Directors expect clinical
studies to begin before the end of 2000.
Research in the Plasminogen Activator Inhibitor-1 (PAI-1) collaboration with
Lilly, which targets the development of a new class of antithrombotic drugs
suitable for chronic use, is being conducted jointly by Xenova and Lilly.
Certain research work in connection with this collaboration was previously
carried out by MetaXen. As part of the transfer of staff and assets of MetaXen
to Exelixis in 1999, Xenova has retained all rights to milestones and royalties
due under this collaboration.
Preclinical research is also continuing with the goal of identifying drug lead
candidates which address the roles of multi-drug resistance protein (mrp) in
cancer and in asthma, and the role of PAI-1 in metastatic cancer.
Proof of principle for the method of action of PAI-1 in cancer was presented by
Xenova at the July 1999 meeting of the British Association for Cancer Research.
Lilly has been granted an option to acquire exclusive rights to develop and
commercialise PAI-1 inhibitors in cancer.
In February 2000 Xenova announced the formation of a collaborative research
agreement for the discovery and development of novel classes of telomerase
inhibitors with Professor Robert Newbold and his team at The Institute of Cancer
Genomics and Pharmacogenomics, Brunel University, Uxbridge, UK.
Management
To reflect the company`s oncology focus, the structure of Xenova`s Scientific
Advisory Board (SAB) was amended in May 1999. The new SAB, led by Professor Stan
Kaye, Head of the Cancer Research Campaign Department of Medical Oncology at the
University of Glasgow, Scotland, is composed of a number of leading oncology
professionals -- Professor Paul Workman, Director of the Cancer Research
Campaign Centre for the Cancer Therapeutics Institute of Cancer Research,
London, Professor Herbie Newell, Director of Cancer Therapeutics at the Cancer
Research Unit, the University of Newcastle upon Tyne, Professor Mike Waterfield,
Director of Research at the Ludwig Institute for Cancer Research at University
College, London and Professor Adrian Harris, Director of the Imperial Cancer
Research Fund Molecular Oncology Laboratories and Director of the ICRF Medical
Oncology Unit in Oxford, England. Professor Harris is also a non-executive
director of Xenova Group plc. Stephen B Howell, Professor of Medicine at the
University of California, San Diego, joined Xenova`s SAB in January 2000.
Following the decision of Dr Paul Bevan to step down from his executive role,
Dr. John Waterfall was appointed as Xenova`s Research and Development Director.
Dr. Waterfall joined Xenova from Hoffmann-La Roche, Nutley, New Jersey, USA,
where he was Divisional Vice President, Global Project Management. Dr. Bevan
remains as a non-executive director of the Company. In May 1999 Dr. Michael
Moore, who was formerly head of Xenova Discovery, was appointed Chief Scientific
Officer with special responsibility for thekVe director of Xenova Group plc,
Mr. Peter Gillett, a partner at audit and financial services firm Ernst & Young,
was appointed as a non-executive director in February 2000. Peter Gillett
currently chairs Xenova`s Audit Committee.
Outlook
Xenova intends to continue to fulfil its strategic objectives through a strategy
which includes the continuing discovery and development of novel drugs of high
commercial potential, where the Group creates and owns the intellectual property
involved and retains commercialisation rights to this intellectual property.
Under this strategy, commercialisation of the products of the Group`s research
may occur through partnering with major pharmaceutical companies at the optimal
point, having regard to the level of scientific and commercial risk and return
for each individual project. This may result in the Group taking products
through to completion of Phase III clinical trials in its core cancer area, and
may result in earlier stage partnering for products for other indications.
Financial Summary
Operating Performance
Turnover for the year was 2.7m pounds ($4.3m) (1998: 4.9m pounds ($7.8m)).
Receipts of 2.3m pounds ($3.7m) under the PAI-1 agreement with Lilly represent
recovery of research expenditure. 1998 PAI-1 receipts of 4.1m pounds ($6.8m)
included milestone payments from Lilly of 1.3m pounds ($2.2m) as well as the
recovery of research expenditure. Turnover in the six months to 31 December 1999
was 0.9m pounds ($1.4m) (1998: 1.9m pounds ($3.1m)), with the decrease primarily
attributable to the transfer in-house to Lilly of work in connection with the
ongoing Xenova/Lilly strategic cardiovascular research and development
programme.
Operating costs declined to 13.6m pounds ($22.0m) (1998: 19.5m pounds ($31.4m))
and comprised 11.3m pounds ($18.2m) (1998: 16.5m pounds ($26.6m)) of research
and development costs and 2.3m pounds ($3.7m) (1998: 3.0m pounds ($4.8m)) of
administrative expenses. The reduction in operating costs reflects the fall in
the headcount at 31 December 1999 to 57 (1998: 123) following the disposal of
the non core businesses and disposal of surplus leasehold property in the US and
UK. Research and development costs for continuing operations increased to 7.8m
pounds ($12.6m) (1998: 6.7m pounds ($10.8m)) reflecting further progress through
clinical trials by XR9576 and XR5000, both of which entered Phase II trials
during the course of 1999. Continuing administrative costs fell to 2.0m pounds
($3.2m) (1998: 2.2m pounds ($3.5m)). Operating loss for the year was 10.9m
pounds ($17.6m) (1998: 14.6m pounds ($23.6m)). Operating loss for the six months
to 31 December 1999 was 4.7m pounds ($7.6m) (1998: 7.8m pounds ($12.5m)).
Disposals
The sale of the majority of the assets of Xenova Discovery Limited to TerraGen
Diversity Inc was completed in April 1999. The sale resulted in total realised
and unrealised gain on disposal of 3.0m pounds ($4.8m). Xenova received a total
of 1.0m pounds cash during 1999 plus 1 million preferred voting shares in
TerraGen Diversity Inc, valued at 1.5m pounds equivalent to 6% of the current
issued share capital. An interest bearing loan note of 1.5m pounds was also
issued to Xenova by TerraGen Diversity Inc. After 24 months the loan note can be
converted into TerraGen equity at the option of either party, and is
automatically convertible at the end of 36 months, which would be equivalent to
a further 6% of the current issued share capital. There is an anti dilution
provision under which if there is a subsequent financing at a lower price then
the conversion price of the loan note will be similarly adjusted. In line with
the issued draft guidance from the Institute of Chartered Accountants in England
and Wales, entitled `The determination of realised profits and distributable
profits in the context of the Companies Act 1985`, the total profit on the
disposal of the Xenova Discovery business disclosed in the Half year and
Quarterly announcements has now been analysed into that which has been realised
and that which is unrealised. Of the total profit of 3.0m pounds, the realised
element of 0.8m pounds has been included in the profit and loss for the year and
the unrealised profit of 2.2m pounds has been taken to the Statement of Total
Recognised Gains and Losses.
The sale of certain of the assets of MetaXen, a San Francisco-based subsidiary,
to Exelixis was completed in July 1999. The sale resulted in a loss on disposal
of 0.5m pounds ($0.8m). Xenova received total cash of 0.1m pounds ($0.2m).
Treasury
Xenova raised a total of 8.4m pounds net ($13.5m) from the placing and exercise
of warrants in the year to 31 December 1999. In July 1999 Xenova made a private
placing of 2,150,038 shares at 85p raising 1.8m pounds ($2.9m). The exercise of
warrants linked to an October 1998 placing and open offer raised 6.6m pounds
($10.6m) in the year.
Capital expenditure during the year was 0.1m pounds ($0.2m) (1998: 2.2m pounds
($3.5m). Proceeds from disposals of tangible fixed assets were 0.2m pounds
($0.3m) (1998: pounds nil).
Net interest of 0.5m pounds ($0.9m) was earned in the year (1998: 0.7m pounds
($1.1m)). Cash and liquid resources at year end were 10.1m pounds ($16.3m)
(1998: 11.4m pounds ($18.4m)).
Called up shares at 31 December 1999 were 54,627,506. Following completion of
the warrant exercise programme in January 2000, shares in issue rose to
54,706,537 as at 3rd March 2000.
The directors do not recommend the payment of a dividend (1998: nil).
Safe Harbor Statement under the US Private Securities Litigation Reform Act of
1995: Some or all of the statements in this document that relate to future
plans, expectations, events, performances and the like are forward-looking
statements, as defined in the US Private Securities Litigation Reform Act of
1995. Actual results of events could differ materially from those described in
the forward-looking statements due to a variety of factors, including those set
forth in the Company`s filings with the US Securities and Exchange Commission.
Alles schoen und gut und warum steht sýe dann beý -20% ýn US ??????
Muß man so was verstehen?
Meiner Meinung sehr einfach,
da steht: "to enter phase III studies in Q 4 2000", also Phase III (die Abschlussphase) BEGINNT im 4. Quartal 2000, da ist noch ein bißchen Zeit für Gewinnmitnahmen.
Aber keine Angst, es wird schon werden.
Tuerk
da steht: "to enter phase III studies in Q 4 2000", also Phase III (die Abschlussphase) BEGINNT im 4. Quartal 2000, da ist noch ein bißchen Zeit für Gewinnmitnahmen.
Aber keine Angst, es wird schon werden.
Tuerk
Dow Jones 10716.54 +134.03 +1.27%
Nasdaq 3727.9 +188.74 +5.33%
XENOVA GROUP ADS (NASDAQ:XNVA) - messages - chart - news - Co. Sleuth - profile - SEC filings
Last Trade
12:30 PM - 2 3/8 Change
0 - (0.00%) Volume
65,800
Day`s Range
2 1/4 - 2 13/32 Bid
2 1/4 Ask
2 3/8 Open
2 5/16 Prev Cls
2 3/8
52-week Range
1 - 10 5/8 Earn/Shr
N/A PE
N/A Div/Shr
N/A Yield
N/A
Nasdaq 3727.9 +188.74 +5.33%
XENOVA GROUP ADS (NASDAQ:XNVA) - messages - chart - news - Co. Sleuth - profile - SEC filings
Last Trade
12:30 PM - 2 3/8 Change
0 - (0.00%) Volume
65,800
Day`s Range
2 1/4 - 2 13/32 Bid
2 1/4 Ask
2 3/8 Open
2 5/16 Prev Cls
2 3/8
52-week Range
1 - 10 5/8 Earn/Shr
N/A PE
N/A Div/Shr
N/A Yield
N/A
Dow Jones 10767.42 +184.91 +1.75%
Nasdaq 3793.57 +254.41 +7.19%
XENOVA GROUP ADS (NASDAQ:XNVA) - messages - chart - news - Co. Sleuth - profile - SEC filings
Last Trade
04:08 PM - 2 9/16 Change
+ 3/16 - (7.89%) Volume
94,700
Day`s Range
2 1/4 - 2 9/16 Bid
2 3/8 Ask
2 9/16 Open
2 5/16 Prev Cls
2 3/8
52-week Range
1 - 10 5/8 Earn/Shr
N/A PE
N/A Div/Shr
N/A Yield
N/A
Nasdaq 3793.57 +254.41 +7.19%
XENOVA GROUP ADS (NASDAQ:XNVA) - messages - chart - news - Co. Sleuth - profile - SEC filings
Last Trade
04:08 PM - 2 9/16 Change
+ 3/16 - (7.89%) Volume
94,700
Day`s Range
2 1/4 - 2 9/16 Bid
2 3/8 Ask
2 9/16 Open
2 5/16 Prev Cls
2 3/8
52-week Range
1 - 10 5/8 Earn/Shr
N/A PE
N/A Div/Shr
N/A Yield
N/A
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