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Life Sciences News Brief
Vol. 6 no. 06 - March 22, 2006
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Pharmaceuticals Update |
AEterna Zentaris Gains Market
Approval for Cetrotide(R) (cetrorelix)
AEterna Zentaris Inc.
(Quebec City) announced it gained market approval for Cetrotide(R) (cetrorelix)
in Japan for in vitro fertilization. Cetrotide(R) (cetrorelix) will
be manufactured and marketed in Japan by partners Nippon Kayaku Co.,
Ltd. and Shionogi & Co., Ltd. AEterna Zentaris obtained an
undisclosed milestone payment from its partners and will receive
revenues from the supply of Cetrotide(R) (cetrorelix) to its
Japanese partners. Cetrotide(R) (cetrorelix) is expected to be
launched in Japan by year-end. Cetrotide(R) (cetrorelix) has been
marketed worldwide (ex-Japan) by Serono S.A. since 1999, providing
AEterna Zentaris with annual revenues of over US$20 million per
year. "We are very pleased that Cetrotide(R) (cetrorelix) has been
approved for in vitro fertilization in Japan and also very proud to
work with such highly respected partners as Nippon Kayaku and
Shionogi to ensure the successful commercialisation of our product
on the Japanese market. This approval marks a significant
achievement for AEterna Zentaris as Cetrotide(R) (cetrorelix) is now
approved worldwide and further demonstrates our ability to develop
and market novel efficient therapies for conditions affecting
millions of people around the world," said Gilles Gagnon, President
and Chief Executive Officer at AEterna Zentaris. http://www.aeternazentaris.com
Stressgen provides corporate and
HspE7 program updates
Stressgen Biotechnologies
Corporation (Victoria) provided a corporate update and details
regarding the next phase of clinical development of HspE7, a novel
investigational therapeutic vaccine for the treatment of serious
human papillomavirus (HPV)-related diseases. The Company had
originally planned to begin a Phase III study in the first quarter
of this year with the original HspE7 formulation. However, the
Company announced that it will now be focusing its resources on the
development of a more potent, reformulated version of HspE7. "Over
the past twelve months, we have streamlined our operations,
leveraged our non-core assets to fund our operations and
re-invigorated the Company with new shareholders, new management and
new members of our Board of Directors. In essence, we have
strengthened all of the critical areas of the Company," stated
Gregory M. McKee, President and Chief Executive Officer of Stressgen.
"And now, following the completion of an in-depth product
evaluation, we have determined that it is in the best interest of
our shareholders to dedicate our resources towards the development
of a reformulated HspE7 compound for the treatment of diseases
caused by HPV." "Impressive preclinical data have been generated
around several reformulated versions of HspE7 combined with low
concentrations of an adjuvant," continued Mr. McKee. "These data
indicate dramatically increased potency, which we believe provides
us with both a clearer and lower-risk commercialization pathway and
may provide expanded marketing opportunities for the compound,
factors that we believe outweigh any delay in the clinical
development pathway of HspE7." http://www.stressgen.com
Neurochem announces eprodisate (Fibrillex(TM))
NDA filed
Neurochem (Laval) announce that the new drug
application (NDA) for eprodisate (Fibrillex(TM)) for the treatment
of Amyloid A (AA) amyloidosis has been filed and granted priority
review by the US Food and Drug Administration (FDA). The FDA
priority review designation establishes a target six-month review
period from the date of receipt of the eprodisate (Fibrillex(TM))
NDA. The PDUFA (Prescription Drug User Fee Act) goal date, when the
FDA is expected to render a decision on the approvability of
eprodisate (Fibrillex(TM)), is August 13, 2006. The FDA grants
priority review to product candidates that would offer a significant
improvement in the treatment, diagnosis or prevention of the disease
or that address an unmet medical need. In a Phase II/III clinical
trial, eprodisate (Fibrillex(TM)) was investigated to evaluate its
safety and efficacy in patients with AA amyloidosis, a disease that
is believed to affect close to 17,000 people in the US. Currently,
there is no FDA-approved therapy to treat AA amyloidosis, a
condition that normally progresses to end-stage renal disease (ESRD),
dialysis and ultimately death.
http://www.neurochem.com |
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Clinical Trials |
Trial to test Cangene's WinRho(R) SDF
in hepatitis C patients
Cangene Toronto) reports
the beginning of a clinical trial at Weill Medical College of
Cornell University in New York City that will test Cangene's
WinRho(R) SDF in patients infected with hepatitis C virus (HCV).
Patients infected with HCV currently receive combination treatment
with the drugs peginterferon alfa-2 and ribavirin, which can cause
severe hematologic effects, including a drop in platelet numbers
called thrombocytopenia. Thrombocytopenia leaves the patient's blood
unable to clot, possibly causing uncontrolled bleeding that can be
fatal. While effective treatments are available for the other
blood-related side effects of HCV therapy, thrombocytopenia has
remained intractable and often requires abatement of therapy.
WinRho(R) SDF is approved in the U.S. for treating a specific type
of thrombocytopenia called ITP (immune thrombocytopenic purpura),
which arises from an attack on platelets by the immune system and
may occur secondary to HIV (human immunodeficiency virus) infection.
This new study will evaluate the safety and efficacy of using
WinRho(R) SDF to offset thrombocytopenia in patients with HCV
infection who are starting, or already receiving, treatment with
peginterferon alfa-2 and ribavirin. Patients with and without HIV
co-infection will be eligible for the trial. http://www.cangene.com
LAB International initiates patient
enrollment for LAB-CGRP Phase IIa trial
LAB International Inc. (Laval), an integrated drug
development company with subsidiaries focused on developing
therapies for the inhalation market and on providing contract
research services, today announced it has enrolled the first patient
in its LAB CGRP Phase IIa trial. The trial is expected to be
completed in the third quarter of 2006. The objectives of this
randomized, double blind, cross-over Phase II study are to
investigate the protective efficacy of LAB CGRP on metacholine
induced bronchial hyper-responsiveness in adult patients with mild
to moderate asthma, to compare this efficacy to salbutamol and
placebo and to evaluate the safety and tolerability of LAB CGRP in
asthma patients. The trial is enrolling a total of 12 patients.
http://www.labinc.ca
Lorus announces down regulation of
GTI-2040 molecular target
Lorus Therapeutics Inc.
(Toronto), a biopharmaceutical company specializing in the research,
development and commercialization of pharmaceutical products and
technologies for the management of cancer, announced publication of
data demonstrating decreased expression of the molecular target for
its antisense drug, GTI-2040, in a Phase II breast cancer clinical
trial. The article titled "Analysis of ribonucleotide reductase M2
mRNA levels in patient samples after GTI-2040 antisense drug
treatment', to be published in the May issue of Oncology Reports
(Volume 15, Issue 5, Pages 1299-1304), presents a case study from a
National Cancer Institute (NCI) sponsored Phase II clinical trial of
GTI-2040 in combination with capecitabine in metastatic breast
cancer. The publication describes the development of a rapid and
practical method to measure ribonucleotide reductase R2 (also known
as M2), a malignant determinant that is the molecular target of
GTI-2040 therapy. The trial is sponsored by the Cancer Therapy
Evaluation Program of the US NCI under a Clinical Trials Agreement
between Lorus and the NCI. In the case presented, a rapid and
dramatic reduction in expression of the gene for the R2 component of
ribonucleotide reductase was demonstrated in tumor biopsy tissue
following treatment with GTI-2040 in combination with capecitabine.
An approximately 25-fold decrease in R2 was seen as early as one day
after the start of GTI-2040 treatment. This finding, in conjunction
with an observed clinical response of six months duration, was
paralleled by an observed reduction of the R2 target in circulating
white blood cells (WBCs). This decrease suggests a potential utility
of WBCs as a "surrogate" tissue for measuring this malignant
determinant, and may also be useful for evaluating the activity of
GTI-2040 in down regulating target gene expression in patients for
whom tumor biopsy is not possible. http://www.lorusthera.com
Transition Reports Positive Interim
Data from Phase I/II Clinical Trial
Transition Therapeutics Inc. (Toronto), announces
interim data from an open label, multi-centre Phase I/II clinical
trial evaluating the interferon enhancing product, HCV-I.E.T., in
hepatitis C non-responders that have completed 12 weeks of
treatment. The clinical trial was designed to evaluate safety and
HCV-I.E.T.'s ability to produce a positive therapeutic response in
patients who have failed to respond to previous treatment with the
current "gold standard" hepatitis C therapies consisting of
pegylated interferon and ribavirin. Hepatitis C non-responders
currently have no treatment alternatives available and are estimated
to represent nearly 45% of all hepatitis C patients. The 12 week
data demonstrated that 7 of 11 (63%) of the hepatitis C
non-responder patients treated with HCV-I.E.T. had a greater than
90% reduction in hepatitis C virus levels, with 3 of 11 (27%)
patients achieving a greater than 99% reduction of virus levels (2
log10 decrease). HCV-I.E.T. combines Transition's interferon
enhancer, EMZ702, with the current standard of care for hepatitis C,
a combination therapy of pegylated interferon alpha and ribavirin.
"It is encouraging to see substantial viral reductions in the
hepatitis C non-responders, a large population of patients facing
many long-term complications from the disease including cirrhosis,
liver failure and liver cancer. Evidence of hepatitis C viral
reduction in this patient population is meaningful and may provide
another treatment option," said Dr. Tony Cruz, Chairman and Chief
Executive Officer of Transition. http://www.transitiontherapeutics.com
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Diagnostics and Therapeutics Update |
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Medical Devices |
Biophage reaches an important
milestone
Biophage Pharma Inc (Montreal) announced that it has
reached an important milestone in the development and
commercialization of its PDS(R) Biosensor. Reception of the first
manufacturing prototype allows the company to enter Phase 4 of its
development program consisting of extensive product tests in both
the market place and in different labs (beta sites) before launch. A
typical 'Stage-Gate(R) product development process' consists of four
stages. Phase 1 is the initial R&D leading to a laboratory
prototype, while Phase 2 and 3 consist of building a business case
and the detailed design and development of the new product.
Reception of the first manufacturing prototype (alpha prototype) is
an important milestone in this approach mainly because it allows the
product to enter in its final design and validation phase (Phase 4)
before its commercialization. "We are extremely pleased by the speed
and high quality performance of our production partner in the design
and development of this alpha prototype of our PDS(R) Biosensor,"
commented Dr. Mandeville, President and CEO of Biophage Pharma.
"Reaching this important milestone puts us a step closer to a
full-scale professional product sample that will be presented to our
potential buyers and to corporations for licensing. We have already
chosen four different Beta testing sites for the completion of Phase
4 of our development and commercialization process." added Dr
Mandeville. http://www.biophagepharma.com
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Genomic Update |
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Industry Briefs |
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Labopharm Inc.
(Laval) announced that
it has filed a preliminary short-form prospectus with Canadian
securities regulators and a registration statement on Form F-10
with the U.S. Securities and Exchange Commission in connection
with an offering of 10 million common shares. http://www.labopharm.com
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Novadaq(R) Technologies Inc.
(Toronto), a developer of medical imaging systems for the
operating room, announced today that it has hired John
Snisarenko as Vice President and General Manager of its
Ophthalmology Business to execute the products commercialization
strategy. http://www.novadaq.com
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Stressgen Biotechnologies Corporation
(Victoria) announced that the Company has hired Peter Emtage,
Ph.D., as its Vice President of Research & Development. Dr.
Emtage most recently led the research, development and technical
operations at Biomira Inc. http://www.stressgen.com
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Chemokine Therapeutics
Corp.
(Vancouver), a biotechnology company developing peptide-based
therapies to treat cancer, blood disorders, cardiovascular and
infectious disease, announced today that it has entered into a
definitive agreement with Pharmaceutical Product Development,
Inc. ("PPD") to re-acquire licensing rights on its compound
CTCE-0214 that it had previously granted to PPD in April 2003.
PPD will retain an interest in the CTCE-0214 program through
potential future milestone payments. http://www.chemokine.net
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(Life Sciences News Briefs © 2005 is prepared by Armar
International for the Life Sciences Branch of Industry Canada (contact:
Louise Leduc Tel: (613) 954-4715; E-mail: Leduc.Louise@ic.gc.ca).
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