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Life Sciences News Brief
Vol. 5 no. 41 - December 21, 2005
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Pharmaceuticals Update |
Chemokine Therapeutics commences
second clinical study for lead drug
Chemokine Therapeutics Corp. (Vancouver), a biotechnology company
developing chemokine-based therapies to treat cancer, blood
disorders, cardiovascular, and infectious diseases, announced that
it has initiated a second clinical study of its lead drug candidate
CTCE-0214. CTCE-0214 is a drug designed to trigger trafficking of
immune system cells and stem cells, as well as regeneration of white
blood cells and platelets. The Company commenced dosing the first
cohort of subjects in the first of a three stage protocol,
undertaken in Tacoma, Washington, that will include at least 50
healthy adult volunteers. The first stage of the clinical study
involves a single dose escalation design followed in stage two by
repeat administration up to three doses. The final stage is designed
to explore the possible synergy of CTCE-0214 used in conjunction
with G-CSF. Overall, the Phase 1b study will allow the Company to
evaluate the safety, pharmacodynamics, and pharmacokinetic profile
of CTCE-0214 as a single injection, multi-dose, and in combination
with granulocyte colony stimulating factor (G-CSF). The Company
expects to announce preliminary results of its clinical trial in the
second half of 2006.
Axcan Exceeds Patient Randomization
Target
Axcan Pharma Inc. (Mont Saint-Hilaire) announced that clinical sites
participating in the North American ITAX (itopride) Phase III trial
have exceeded the goal of randomizing 500 patients. Additional
patients are still in the screening process, and Axcan intends to
continue randomization until the end of December 2005, consistent
with previously announced study timelines. As disclosed on November
10, 2005, all patients required for completion of the international
study have already been randomized. The goal of this clinical
development program, consisting of two pivotal Phase III trials, a
North American and an international clinical study, is to assess the
safety and efficacy of Itopride in the treatment of Functional
Dyspepsia, a gastrointestinal disorder. Axcan expects to release the
overall outcome of the international Phase III clinical trial during
the first half of calendar 2006, followed shortly afterwards by that
of the North American Phase III trial. Detailed results of the
studies will most likely be subsequently presented at a major
gastroenterology scientific conference.
Nuvo forms panel of FDA experts in
anticipation of pivotal trial results
Nuvo Research Inc. (Markham) announced that it
anticipates completing its pivotal phase III trial for Pennsaid(R)
by year-end and disclosing preliminary results from the trial in
January 2006. In anticipation of filing an amended New Drug
Application for Pennsaid(R) with the U.S. Food and Drug
Administration (FDA) in mid-2006, Nuvo has formed an FDA advisory
panel to guide its FDA submission. Pennsaid(R), a topical
non-steroidal anti-inflammatory (NSAID) used for the treatment of
osteoarthritis, is approved for sale in Canada and several European
countries. |
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Diagnostics and Therapeutics Update |
Skin Sterol Linked to Hidden Heart
Disease
A
novel, non-invasive test that measures skin tissue cholesterol can
detect early vascular disease, according to data published in the
American Heart Journal. Skin tissue cholesterol, measured
non-invasively by PREVU(*) Point of Care (POC) Skin Sterol Test, has
a significant association with increased carotid intima-media
thickness (CIMT), which is an independent predictor of myocardial
infarction and stroke. "We are continuing to build on this exciting
data with a 600-person trial (PASA) now underway to further examine
the relationship between skin sterol and CIMT," said Dr. Brent
Norton, President and Chief Executive Officer, PreMD Inc.
Protox files IND for the treatment of
prostate cancer
Protox Therapeutics Inc. (Vancouver) announced that it has submitted
an investigational new drug (IND) application to the U.S. Food and
Drug Administration (FDA) for the Company's lead product, PRX302.
Protox plans to initiate Phase 1 clinical trials of PRX302, for the
treatment of recurrent localized prostate cancer, early next year
upon approval of the IND by the FDA.
Patheon Resumes Normal Production of
Omnicef(R) Oral Powder
Patheon Inc. (Toronto) announced that its subsidiary, CEPH
International Corporation, has resumed normal production and
shipments to its client of Omnicef(R) oral powder for suspension
product at its facility in Carolina, Puerto Rico. This follows
qualification of new equipment and validation of processes for
manufacturing of the product in accordance with a plan developed by
CEPH to respond to an FDA Warning Letter received in September 2005.
CEPH has also notified the FDA that it has resumed normal production
and shipments. The FDA may conduct a re-inspection of the Carolina
facility in connection with CEPH's plan.
Protox files foundation patent for
PORxin(TM) technology
Protox Therapeutics Inc. (Vancouver) announced that it has filed a
provisional patent application with the United States Patent and
Trademark Office entitled "Modified Pore-Forming Toxins and Use
Thereof". This is a foundational patent application, intended to
encompass and protect several aspects of the Company's entire
PORxin(TM) technology. Under this application the Company's ability
to develop individual protoxin candidates to act as either "broad
spectrum" anti-cancer agents or to treat specific cancer types would
be protected.
The World Economic Forum selects
Genotek
The World Economic Forum (WEF) announced that it has
selected DNA Genotek (Ottawa) as one of 36 Technology Pioneer
companies for 2006. The WEF annually selects companies based on
their potential for long-term market leadership, positive impact on
business and society, innovation, and leadership. DNA Genotek’s
Oragene™ DNA Self-Collection Kit enables health researchers and
clinicians to easily, reliably, and cost-effectively collect and
preserve DNA samples. DNA Genotek is the only Canadian company
selected as a 2006 WEF Technology Pioneer. |
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Medical Devices |
MedMira to Commercialize
Revolutionary New Diagnostic Technology
MedMira Inc., (Halifax) the global market leader in
premium rapid diagnostic solutions, announced that it has acquired
SensorChem International Corp. based in Toronto in order to bring a
revolutionary, new biosensor technology platform to international
diagnostic markets. Working under the name "Project Maple", this new
acquisition will see MedMira broaden its product offering based on
this breakthrough technology platform, which was invented by a team
of University of Toronto researchers, led by Dr. Michael Thompson,
Professor of Analytical Chemistry within the Department of Chemistry
and associated member of the Institute for Biomaterials and
Biomedical Engineering. The new products and applications resulting
from Project Maple will complement MedMira's current product
portfolio, which presently consists of rapid flow through
point-of-care tests for HIV, Hepatitis C, and other infectious
diseases. As with MedMira's existing, market-leading technology
platform, the new products derived from Project Maple will be
extremely versatile, allowing users to assess multiple diagnostic
markers quickly and efficiently. The simplicity of this new
technology will facilitate a fast turnaround time in patient
point-of-care testing, and can be easily implemented in clinics,
hospitals, central laboratories as well as for personal home use.
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Genomic Update |
Researchers identify key protein
involved in neuropathic pain
A team of researchers led by Université Laval and The
Hospital for Sick Children has discovered a protein that plays a
major role in neuropathic pain. This discovery, published in the
December 16 issue of Nature, paves the way for the development of
new diagnostics and treatments for chronic pain. Neuropathic pain is
a common and severely disabling state that affects millions of
people worldwide. Many people suffering from neuropathic pain appear
normal, but are in agony experiencing lightning-like pain known as
allodynia. This type of pain can alter perception to a point where
previously innocuous or even pleasurable stimuli applied to the skin
or tissues become extremely painful. It may be experienced after
nerve injury or from diseases that affect peripheral nerve function
such as diabetes, shingles, or cancer. After a peripheral nerve
injury there is a biophysical change in spinal cord cells called
microglia. Microglia are typically considered to be immune cells in
the nervous system, but have now been proven to be involved in
neuropathic pain. "We knew that microglia had to communicate with
nerve cells in the pain-processing network in the spinal cord.
However the mechanism for this communication was not known," said
Dr. Michael Salter, co-principal investigator, senior scientist at
SickKids, professor of Physiology at the University of Toronto (U of
T), and director of the U of T Centre for the Study of Pain. "We
discovered that the microglia talk to the nerves cells by releasing
Brain-Derived Neurotropic Factor (BDNF)." When BDNF was injected
into the spinal cords of normal mice it resulted in allodynia. When
the team made manipulations to block or intercept BDNF signaling
from the microglia the in nerve-injured mice the allodynia was
reversed. "We established that the microglia cause chloride ions to
increase inside the nerve cells and that BDNF is the mystery
mediator," said Dr. Yves De Koninck, co-principal investigator,
professor, Department of Psychiatry, Université Laval and director
of the Division of Cellular Neurobiology at the Centre de recherche
Université Laval Robert-Giffard. "Thus, not only did we discover
that BDNF is the chemical mediator, but we also determined how BDNF
works." |
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Industry Briefs |
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Hemosol Corp.
(Toronto) announced that the Ontario Superior Court of Justice
approved a forty-five day extension of the time by which Hemosol
Corp. and its affiliate Hemosol LP are required to file
proposals for their respective creditors pursuant to the
provisions of the Bankruptcy and Insolvency Act (Canada).
Subject to further orders of the Superior Court, Hemosol will
have until February 10, 2006 to file one or more proposals…….
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BCY LifeSciences Inc. (Toronto)
announced an update on the status of its previously announced
business combination with Pipex Therapeutics, Inc, a
privately-held biopharmaceutical company located in Ann Arbor,
Michigan. BCY and Pipex are currently working through the
details of the business combination and BCY will provide a
further status report once further details are available…….
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Vasogen Inc. (Toronto), a leader
in the research and commercial development of technologies
targeting the chronic inflammation underlying cardiovascular and
neurological disease, announced the promotion of Christopher J.
Waddick to the position of Chief Operating Officer and the
appointments of Paul J. Van Damme as Vice President, Finance and
Chief Financial Officer and Jacqueline H.R. Le Saux as Vice
President, Corporate and Legal Affairs…….
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Microbix Biosystems Inc.
(Toronto) announced that Elliott W. Knox, a director since 2000,
is stepping down from the Board of Directors and that Dr. Peter
M. Blecher has been appointed…….
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Response Biomedical Corp.
(Vancouver), announced that it is undertaking a non-brokered
private placement of up to 4,000,000 units at a price of $0.50
per unit, each unit consisting of one common share and one-half
of one common share purchase warrant. Each whole warrant shall
entitle the holder thereof to purchase one common share of the
Company at a price of $0.70 per share for a period of 24 months
from the closing date of the private placement. Shares and
warrants will be subject to a four month hold period from the
date of close………
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Millenium Biologix Corporation
(Kingston), a leading biomedical company developing minimally
invasive medical devices and skeletal tissue regeneration
products for targeted orthopedic uses, announced it has
completed its previously announced $15 million private placement
and appointed new directors…….
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ARIUS Research Inc. (Toronto)
announced that it had closed a previously-announced convertible
bridge loan facility in the amount of US$2,000,000 from Xmark
Opportunity Fund, L.P., Xmark Opportunity Fund, Ltd. and Xmark
JV Investment Partners, LLC. The Company will use funds drawn
from this loan facility for working capital, to fund development
of the Company's programs and for general corporate purposes.
The facility was arranged by Dundee Securities Corp. on behalf
of ARIUS…….
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QLT Inc. (Vancouver) announced
that the Toronto Stock Exchange has accepted notice of the
amendment announced on December 8, 2005 to the terms of QLT's
normal course issuer bid which was originally approved by the
Exchange and announced on May 2, 2005. The amended bid allows
QLT, commencing on or about December 14, 2005 until May 3, 2006,
to purchase for cancellation up to a maximum of 9,300,000 common
shares without par value, being approximately 9.9% of the issued
and outstanding common shares of QLT as at April 28, 2005, and
representing approximately 10% of its public float, subject to a
maximum aggregate expenditure by QLT of US$100 million……..
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DRAXIS Health Inc. (Mississauga)
has received approval of its Notice of Intention from the
Toronto Stock Exchange (TSX) for its previously announced Normal
Course Issuer Bid to repurchase for cancellation up to 3,522,530
of its common shares, which represents 10% of the 35,225,296
common shares in the public float as at December 6, 2005…….
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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, announced that it has
raised $12.3 million through the non-brokered private placement
of 13 996 466 common shares at a price of $0.88 per share.
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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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