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Life Sciences News Brief
Vol. 6 no. 14 - May 17, 2006
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Pharmaceuticals Update |
Cipher receives FDA response to CIP-ISOTRETINOIN
NDA submission
Cipher Pharmaceuticals
Inc. (Mississauga) announced that it has received an approvable
letter from the U.S. Food and Drug Administration (FDA) pertaining
to its New Drug Application (NDA) for CIP-ISOTRETINOIN, the
Company's innovative formulation of the acne medication isotretinoin.
In the letter, the FDA requested that the Company, prior to
receiving approval, provide additional clinical data and some
further details relating to chemistry, manufacturing and controls
(CMC) for the product. The Company is currently assessing these
requests, including what additional clinical data may be required
and is planning the most appropriate next steps in consultation with
its clinical and regulatory advisors. http://www.cipherpharma.com
Women with low vitamin D levels have
small infants
Pregnant women with
relatively low amounts of vitamin D in their diets tend to give
birth to smaller infants, a new study suggests. Canadian researchers
found that pregnant women who drank little milk or had a lower
vitamin D intake tended to have smaller babies than women with
higher intakes. Fortified milk is a primary source of vitamin D in
Western diets, and the nutrient may be the main reason why women's
milk consumption was linked to birthweight, according to the
researchers. "Absence of vitamin D seems to be what's driving this,"
said study co-author Dr. Kristine G. Koski, of McGill University in
Montreal. What's more, the study suggests, vitamin D deficiency is
not required to potentially affect fetal growth. Although vitamin D
intake was lower among women who avoided milk, it was still, on
average, within the recommended range. This suggests that pregnant
women need more than the current "adequate" intake level for vitamin
D - 5 micrograms for adults age 50 and younger, Koski said. She and
her colleagues report the findings in the current issue of the
Canadian Medical Association Journal. http://www.cma.ca
Stem Cell Therapeutics Announces
Issuance of Second US Patent
Stem Cell Therapeutics
Corp. (Calgary) announced that the U.S. Patent and Trademark Office
has granted U.S. Patent 7,033,995 to the company's wholly-owned
subsidiary, Stem Cell Therapeutics Inc. The patent, entitled
"Production of Radial Glial Cells", protects novel methods of
producing radial glial cells in the brain. The production of radial
glial cells in the brain of a patient suffering from a central
nervous system (CNS) disease has the potential to be a fundamental
technology in the field, key to the successful development of neural
stem cell based approaches for the treatment of many CNS diseases.
CNS diseases possibly affected by successful implementation of this
technology include stroke, acute brain injury, Alzheimer's disease,
Multiple Sclerosis, Huntington's disease, Amyotrophic Lateral
Sclerosis, and Parkinson's disease. http://www.stemcellthera.com
Cytochroma announces significant
results with CTA002
Cytochroma Inc. (Markham) announced that CTA002, a
novel vitamin D analog and inhibitor of the CYP24 enzyme, in
combination with a standard cytotoxic agent, demonstrated potent
anti-cancer activity in a xenograft prostate model. Using the LNCaP
prostate model, Cytochroma was able to demonstrate a significant
effect on tumor suppression with CTA002 in combination with
paclitaxel. After one month, this combination resulted in tumor
growth suppression of 99% by the end of the treatment period
compared to 82% using paclitaxel alone. More significant was the
lasting tumor-suppressing effects that were evident 28 days after
the treatment ended. Tumor growth suppression using the combination
of CTA002 and paclitaxel was maintained at 89% compared to only 45%
using paclitaxel alone. http://www.cytochroma.com |
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Clinical Trials |
Protox Successfully Doses First
Patient in Prostate Cancer Trial
Protox Therapeutics Inc.
(Vancouver) announced the enrollment and successful dosing of the
first patient in a Phase I clinical study evaluating their lead
drug, PRX302, to treat localized recurrent prostate cancer. PRX302
is a targeted pro-drug that turns into a potent anti-cancer agent
once activated by the enzyme, prostate specific antigen (PSA),
produced in high levels by prostate cancer and hyperplastic prostate
cells. Once activated, PRX302 destroys the cells by punching holes
in the cell membrane. In pre-clinical studies, PRX302 has been shown
to selectively and potently kill PSA-producing cells without harming
adjacent healthy tissues or organs. PRX302 has the potential to
address the unmet needs of millions of men suffering from localized
prostate cancer and enlarged prostates (benign prostatic hyperplasia
or BPH). http://www.protoxtherapeutics.com
Chemokine achieves milestone with the
start of a phase Ib/II clinical trial
Chemokine Therapeutics
Corp. (Vancouver), a biotechnology company developing drugs in the
field of chemokines, announced that it has started patient dosing in
a phase Ib/II clinical trial using CTCE-9908, the Company's lead
anti-cancer product. The start of this trial is an important
milestone for the Company as it will be the first investigation of
CTCE-9908's safety and ability to reduce the spread of cancer in
humans after several doses. A previously completed phase I clinical
trial demonstrated CTCE-9908 to be safe and well tolerated by study
subjects after a single dose. The new phase Ib/II clinical trial
will involve testing the drug in up to 30 patients with late stage
cancers to evaluate safety and preliminary efficacy. The trial will
study CTCE-9908 in patients with some of the most common cancers
such as breast, lung, prostate, and ovarian.
http://www.chemokine.net
BioMS Medical expands pivotal
multiple sclerosis trial into Denmark
BioMS Medical Corp
(Edmonton), a leading developer in the treatment of multiple
sclerosis (MS), announced it has received approval from the Danish
Medicines Agency to start patient enrolment in Denmark for its
pivotal phase II/III clinical trial of MBP8298, a proprietary
synthetic peptide for the treatment of secondary progressive
multiple sclerosis (SPMS). "Adding these additional trial sites to
our ongoing pivotal MS trial will provide us with a broader
population base for enrolment and strengthen our presence in Europe
beyond the United Kingdom and Sweden into Denmark," said Kevin
Giese, President of BioMS Medical. http://www.biomsmedical.com
BioMS Medical reaches milestone in
pivotal multiple sclerosis trial
BioMS Medical Corp (Edmonton), a leading developer in
the treatment of multiple sclerosis (MS), today announced that more
than 200 patients have been enrolled in its pivotal phase II/III
clinical trial for the treatment of secondary progressive multiple
sclerosis (SPMS). An interim safety and efficacy analysis will be
performed on data from the first 200 patients enrolled when they
have completed 24 months of the clinical trial. "This is an
important milestone event as it sets the clock as to when the
independent Data Safety Monitoring Board (DSMB) will initiate their
review of the interim data and report on any significant preliminary
findings," said Kevin Giese, President of BioMS Medical. "With more
than 200 patients enrolled and close to 300 patients screened
to-date, our pivotal trial is progressing very well." http://www.biomsmedical.com |
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Diagnostics and Therapeutics Update |
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Medical Devices |
Novadaq Announces Study Results
Novadaq(R) Technologies
Inc. (Toronto), a developer of medical imaging systems for the
operating room, announced that research findings from an independent
multi-center study, "New Technology: Real-time Intra-operative
Visual Assessment of Coronary Artery Bypass Graft (CABG) Patency,"
were presented at the American Heart Association's 7th Scientific
Forum on Quality of Care and Outcomes Research in Cardiovascular
Disease and Stroke, in Washington, DC. Initial results indicated
surgeons can immediately view the effectiveness of the bypass grafts
through the use of Novadaq's SPY(R) System and make necessary
corrections during heart surgery. Novadaq's SPY System, commercially
available worldwide, enables cardiac surgeons to visually assess
coronary vasculature and bypass grafts during the course of CABG
procedures. In this particular independent study, a total of 157
patients who underwent elective, or urgent CABG surgery, were
studied in this multi-center trial of five leading U.S. heart
surgery programs. During the 478 bypasses performed, there were no
system, or dye-related complications and the surgeons report the
learning curve for interpreting the images was short, and led to
appropriate and effective bypass revisions. http://www.novadaq.com
Biophage signs a collaborative
agreement with Héma-Québec
Biophage Pharma Inc
(Montreal) announced that it has initiated an R&D program with
Héma-Québec for the evaluation of the potential use of the PDS(R)
biosensor for the detection of bacterial contamination in standard
platelet concentrates. During this collaboration, Héma-Québec agrees
to provide platelet samples to Biophage for laboratory testing in
order to confirm the potential use of the PDS(R) biosensor for
bacterial screening. http://www.biophage.com
VSM reports progress using MEG for
diagnosing Alzheimer's/Parkinson's
VSM MedTech Ltd.
(Vancouver), a world leader in the emerging clinical market for
magnetoencephalography (MEG) functional brain imaging systems,
reported on progress in the diagnosis of Alzheimer's disease and
Parkinson's disease by researchers at VU University Medical Center
in Amsterdam, Netherlands. Preliminary results indicate that a
software platform and protocols involving a five to ten minute test
developed by the MEG Center at VU University Medical Center may be
effective for identifying disruption in intra- and inter-hemispheric
synchronization in patients with these two cognitive disorders. The
results were discussed publicly in a recent VSM-supported Amsterdam
symposium on "New Approaches to Clinical Use of MEG."
http://www.vsmmedtech.com
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Genomic Update |
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Industry Briefs |
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ConjuChem Inc.
(Montreal) announced
theappointment of Thomas R. Ulich, M.D. as Executive Vice
President, Research and Development, effective May 23rd. http://www.conjuchem.com
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Axcan Pharma Inc.
(Mont St Hilaire) announced the appointment of Alexandre P.
LeBeaut, M.D., as Senior Vice President and Chief Scientific
Officer. Dr. LeBeaut will replace François Martin, M.D., who
will continue to serve Axcan in an advisory role through
September 30, 2006 to ensure a smooth and effective transition
of responsibilities. http://www.axcan.com
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ChondroGene Limited
(Toronto) reported
that David J. Tyler has joined ChondroGene as Director, Product
Development and Quality Assurance. http://www.chondrogene.com
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YM BioSciences Inc.
(Mississauga) announced it has completed the acquisition of
Eximias Pharmaceutical Corporation (Berwyn, Pennsylvania), a
privately-held pharmaceutical company engaged in the
acquisition, development and commercialization of products for
the treatment of cancer and cancer-related disorders. http://www.ymbiosciences.com
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ChondroGene Limited
(Toronto) announced that it has entered into an agreement with
Westwind Partners Inc. who have agreed to purchase through a
syndicate, on a bought deal private placement basis, 12,500,000
common shares of the Company at a price of $1.60 per share, for
aggregate gross proceeds of $20.0 million. http://www.chondrogene.com
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Labopharm Inc.
(Laval) announced the
completion of its previously announced public offering of
12,650,000 common shares, which includes exercise in full of the
underwriters' over-allotment option. The common shares were sold
at a price of US$8.00 per share for total estimated net proceeds
to the Company of US$93.3 million (CDN$104.8 million)(1), after
deducting underwriting discounts and commissions and estimated
offering expenses. http://www.labopharm.com
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Biovail Corporation
(Toronto) announced
that it has named Dr. Peter Silverstone Senior Vice-President,
Medical and Scientific Affairs. Dr. Silverstone will focus on
the rapid clinical development and the effective registration of
Biovail's pipeline products. http://www.biovail.com.
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Labopharm Inc.
(Laval) announced that it has signed a licensing and
distribution agreement with Grunenthal GmbH for its once-daily
tramadol product for Belgium. http://www.labopharm.com
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Inex Pharmaceuticals
Corporation
(Vancouver) announced that it has closed the
previously announced transaction to license three products from
its Targeted Chemotherapy pipeline to Hana Biosciences, Inc.
INEX has granted Hana a worldwide license to develop and
commercialize Marqibo(TM) (sphingosomal vincristine), INX-0125 (sphingosomal
vinorelbine) and INX-0076 (sphingosomal topotecan). http://www.inexpharm.com
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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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