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Life Sciences News Brief
Vol. 5 no. 22 - July 13, 2005
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Pharmaceuticals Update |
Vasogen Announces Successful Results From Phase I Clinical Trial
Vasogen Inc. (Toronto), focused on the research and commercial
development of technologies targeting chronic inflammation
underlying cardiovascular and neurological disease, announced the
successful completion of its phase I clinical trial of VP025, the
lead drug candidate from its VP series of drugs. VP025 is being
developed to regulate chronic inflammation of the central nervous
system associated with a number of severe neurological conditions,
such as Alzheimer's disease. The double-blind, placebo-controlled,
phase I dose-escalation trial of VP025 examined the safety and
tolerability of three doses of VP025 in 24 healthy volunteers.
Multiple administrations of either low, mid, or high doses of VP025
were shown to be safe and well tolerated when compared to placebo
and no drug-related serious adverse events were reported.
Neurochem Completes Patient Recruitment For Phase III Clinical
Trial
Neurochem Inc. (Laval) announced the completion of recruitment of
the 950 patients with mild-to- moderate Alzheimer's Disease (AD) for
its North American Phase III clinical trial for Alzhemed(TM), the
Company's investigational product candidate for the treatment of AD.
The trial is being conducted in 51 U.S. and 17 Canadian clinical
centers across North America. The Company has completed the
selection of sites for a similarly sized Phase III clinical trial in
Europe and expects to begin patient recruitment in the fall of 2005.
Lorus completes Phase III clinical trial of Virulizin(R)
Lorus Therapeutics (Toronto), a biopharmaceutical company
specializing in the development and commercialization of
pharmaceutical products and technologies for the management of
cancer announced the successful completion of Last Patient Visit (LPV)
in the Global Phase III clinical study of Virulizin(R) in
combination with Gemzar(R) for the treatment of pancreatic cancer.
This Phase III clinical registration study has been ongoing since
early 2002. The study has enrolled 436 patients at over 100 clinical
sites in North America and Europe. This phase III clinical study
compares the efficacy and safety of Virulizin(R) when combined with
Gemzar(R) versus a placebo combined with Gemzar(R) in patients with
locally advanced or metastatic pancreatic cancer. The primary
efficacy endpoint is overall survival, while secondary endpoints
include progression of symptoms of pain, deterioration of
performance status and weight loss.
Canada Opens Door to Return of Merck's Vioxx
The Canadian government said that Merck & Co. Inc. would have to
make a new drug submission to market its arthritis drug Vioxx again,
but it saw no reason not to approve the application. Speaking after
an advisory panel recommended allowing Vioxx back on the market, the
director of the federal health department's marketed pharmaceuticals
division, Marc Berthiaume, said any application would be judged on
its own merits.
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Diagnostics and Therapeutics Update |
Saturated fats, genetic trait implicated in development of type 2
diabetes
A University of Alberta team of researchers has discovered an
additional 2 million Canadians who have a high fat diet or are
overweight may be at increased risk for developing type 2 diabetes
if they carry a particular type of common specific genetic trait
known as a polymorphism. In work published in the journal, Diabetes,
pharmacology professor Peter Light and graduate student Michael
Riedel suggest that saturated and trans fats are much more effective
activators of a specific potassium channel found in the
pancreas--known when activated to reduce insulin secretion from the
pancreas and increase blood sugar levels. This effect, they say, is
amplified in the polymorphic potassium channel. Interestingly, it
seems that polyunsaturated fats are poor activators of the potassium
channel. "We're suggesting that people with this specific potassium
channel polymorphism--about 2 million Canadians--may be more
susceptible to type 2 diabetes if they have a high fat diet or are
overweight, two of the biggest risk factors for type 2 diabetes,"
Dr. Light explains. "This may explain why 20 percent of type 2
diabetic Caucasians carry two copies of this polymorphism in their
genes compared to only 10 percent in the non-diabetic Caucasian
population." The researchers say this discovery opens up the
distinct possibility of specific genetic screening of people at risk
for type 2 diabetes, which would then give physicians additional
information to advise their high-risk patients on preventative diet
and exercise options.
Advitech Announces Positive Results Of XP-828L Study In Psoriasis
Advitech Inc. (Quebec City), reported positive results from its
recently completed randomized, multi-center, double-blind,
placebo-controlled clinical trial of XP-828L, its new oral product
for treating mild-to-moderate psoriasis. The main objective of the
112-day study, involving 84 patients, was to confirm the efficacy
and safety of XP-828L. Robert Bissonnette, M.D., and Yves Poulin,
M.D., two renowned dermatologists who have been involved in several
clinical trials on psoriasis, conducted the study. In 2004, Advitech
conducted an open study on eleven patients with mild-to-moderate
psoriasis.
Theratechnologies launches Phase III Clinical Trial For TH9507
Theratechnologies (Montreal) announced that on June 30 a patient in
Atlanta, Georgia, became the first to begin treatment in the Phase
III clinical trial testing Theratechnologies' TH9507 (ThGRF)
compound in HIV associated lipodystrophy, a condition that affects
many patients undergoing HIV antiretroviral therapy. "I am pleased
to report that the Phase III study got off the ground on June 30, in
keeping with our mid-year objective," noted Yves Rosconi, President
and Chief Executive Officer of Theratechnologies. "Including the
Atlanta site, we now have 6 of the projected 35 sites actively
recruiting patients and we are working hard towards opening the
remaining 29 sites and recruiting the 400 patients we need to
complete the study. Our goal is to announce results in the second
half of 2006," Mr. Rosconi added.
LAB Initiates Enrollment In Phase II Trial For Its GHRH Product
LAB International Inc. (Laval), an integrated drug development
company with subsidiaries focused on developing therapies for the
inhalation market, and on contract research services announced that
it has initiated a Phase II trial for its Growth Hormone Releasing
Hormone (GHRH) analogue. The placebo controlled Phase II trial to be
conducted in a single center in Europe is investigating the efficacy
and safety of GHRH for the treatment of malnutrition in patients
with late pre-dialysis chronic renal failure. A total of thirty-two
(32) patients will be enrolled in the study, which is expected to be
completed before the end of the year. The Company anticipates
demonstrating an increase in growth hormone secretion levels as well
as other surrogate markers such as IGF-1 and improvement in
biochemical indicators of the nutritional and metabolic state.
IMI announces major clinical trial with ColorectAlert(TM)
IMI International Medical Innovations Inc. (Toronto) announced a
collaborative research agreement with members of the U.S. National
Cancer Institute's (NCI) Early Detection Research Network's (EDRN)
Great Lakes-New England Clinical Epidemiology Center Consortium (GLNE
CEC Consortium) to include IMI's ColorectAlert(TM) test in a major
colorectal cancer clinical trial. The EDRN, funded by the NCI,
focuses on the development, testing and evaluation of promising
biomarkers or technologies for the early detection of cancer.
NIR Diagnostics granted medical device licence by Health Canada
for
NIR Diagnostics Inc. (Campbellville), the leading developer of
handheld reagentless spectroscopy based medical instruments,
announced that Health Canada has granted a new medical device
licence to the Company for HemoNIR(TM)LAB. The licence, consistent
with the application the Company submitted, allows NIR Diagnostics
to sell the device for laboratory use only, for blood testing in
Canada. The Health Canada decision coincides with the recent market
clearance issued by the United States Food and Drug Administration
(FDA) to market HemoNIR(TM)LAB in the U.S. The HemoNIR LAB device
uses NIR Diagnostics' proprietary near-infrared light technology to
allow laboratory personnel to quickly, accurately, painlessly and
inexpensively diagnose life-threatening problems such as internal
bleeding or carbon monoxide poisoning. Health Canada licenced
HemoNIR(TM)LAB based on the Company establishing safety and
effectiveness of the device.
The FDA approves ACZONE(TM) Gel for the treatment of acne
QLT Inc. (Vancouver) announced that it has received final approval
from the U.S. Food and Drug Administration (FDA) to market ACZONE(TM)
(dapsone) Gel, 5% for the topical treatment of acne vulgaris.
Patients will need to be screened to detect if they are predisposed
to one type of anemia (hemolytic anemia) because of a specific
enzyme deficiency, G6PD (Glucose 6-phosphate dehydrogenase)
deficiency. Patients who have this enzyme deficiency will need to be
monitored with regular blood counts. In the ACZONE clinical trial
program, 1.4% of about 3500 patients had this disorder which is
consistent with the incidence in the general North American
population. Certain populations, mainly males of African American
descent, have a higher reported incidence of approximately 10-14%.
QLT will undertake a post-approval Phase IV study in 50 acne
patients who have G6PD deficiency and follow them for 6 months,
after which QLT expects to submit an application to the FDA to
re-evaluate the ACZONE label.
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Medical Devices |
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Genomic Update |
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Industry Briefs |
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Welichem Biotech Inc.
(Vancouver) announced changes to its Board of Directors. John R.
North has resigned from the Board of Directors due to other
business commitments. John Dustan, a retired senior portfolio
manager, has been named to replace him……
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Transition Therapeutics Inc. (Toronto)
announced that the U.S. Patent and Trademark Office has granted
US Patent No. 6,908,611 to the Company. The claims in this
patent cover the use of Transition's interferon enhancer,
EMZ702, and interferons for the treatment of viral diseases
including hepatitis ……
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Millenium Biologix Corporation (Kingston)
announced that it has provided a Class II 510(k) submission to
the U.S. Food and Drug Administration (FDA) to market and sell
its Microporous Skelite(TM) Resorbable Cement Restrictor product
in the United States. Millenium's Microporous Skelite(TM)
Technology offers improved structural performance, and may be
useful in certain high stress applications……
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TSO3 Inc. (Quebec City) announced the closing
of its previously announced private placement on a firm
underwritten basis for the purchase of 3,750,000 units at Cdn
$2.00 per unit (the "Issue Price"). The Underwriters have also
exercised their option to purchase an additional 1,250,000 units
at the Issue Price, for total gross proceeds of Cdn $10
million……
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Transition Therapeutics Inc. (Toronto)
announced its head office relocation to the Medical and Related
Sciences (MaRS) Discovery District in downtown Toronto.
Transition Therapeutics new offices will be located at 101
College Street, Suite 220, Toronto, Ontario M5G 1L7. Phone and
fax numbers remain unchanged…….
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Advanced Bioelectric (Gatineau), a manufacturer
of heart-monitoring technologies, announced that it has received
Health Canada approval for its first product, the AccuHeart™
Electrode Belt that captures ECG (electrocardiogram) signals……
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Chemokine Therapeutics Corp. (Vancouver), a
biotechnology company developing peptide-based therapies to
treat cancer, blood disorders, cardiovascular, and infectious
diseases, is pleased to advise investors that coverage has been
initiated by Fundamental Research Corp. ("FRC") an independent
equity research firm…….
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Aegera Therapeutics Inc., (Montreal) a clinical
stage biotechnology company uniquely focused on apoptosis
control, announced the appointment of Dr. Jacques Jolivet, M.D.,
to its executive team as Vice President, Clinical Development……
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QLT Inc. (Vancouver) announced that by mutual
agreement it would acquire all rights to Aczone gel for the
treatment of inflammatory and non-inflammatory acne, ending its
Collaboration, Licensing and Supply Agreement partnership with
Astellas US LLC.
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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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