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Life Sciences News Brief
Vol. 5 No. 4 – March 9, 2005
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Pharmaceuticals Update |
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ConjuChem addresses increased
trading activity, R&D Symposium
At the request of the
Toronto Stock Exchange and in response to recent increased trading
activity in its shares, ConjuChem Inc. (Montreal) announced that at
this time there are no matters which could be considered to be
undisclosed material changes relating to the Company or its
business. ConjuChem will present the results from a Phase I trial
with modified diluents at an R&D Investor Symposium to be undertaken
in N.Y. on April 19, 2005 and in Toronto on April 20, 2005. A
diluent is a liquid solution that the drug, a dry powder, mixes with
just prior to administration. These modified diluents were
specifically formulated to improve the drug's tolerability,
especially at higher doses. During the R&D Investor Symposium, in
addition to a research pipeline update, the Company will provide
further details from the Phase II trial with DAC(TM):GLP-1 in
combination with Metformin as well as sub-analysis data from this
trial. On December 15, 2004 ConjuChem announced the main results
from the Phase II Clinical Trial with DAC(TM):GLP-1 in combination
with Metformin reporting positive efficacy results which succeeded
in hitting the primary end-point of a statistically significant
reduction of blood glucose levels in patients who were on oral
anti-diabetic medications, however not in glycemic control. During
this study, the compound was well tolerated with no serious
drug-related adverse events reported.
Oncolytics Receives FDA
Clearance to Clinical Trial
Oncolytics Biotech Inc. (Calgary) announced that it has received
clearance from the US Food and Drug Administration (FDA) to begin a
Phase I/II clinical trial to investigate the use of REOLYSIN(R) to
treat patients with recurrent malignant gliomas. The principal
investigator for the trial is Dr. James Markert, Professor,
Neurosurgery and Physiology, the University of Alabama at
Birmingham. "Treatment of specific cancers, such as brain cancer,
with local or regional administration of REOLYSIN(R) is part of
Oncolytics' clinical strategy," said Dr. Brad Thompson, President
and CEO of Oncolytics. "The U.S. study will complement our Canadian
recurrent malignant gliomas study by employing an alternative method
of product delivery to the tumour site in the brain."
YM BioSciences and
Oncoscience Report Response Rate of 35.3%
YM
BioSciences Inc. (Mississauga) announced that it has been advised by
its European partner, Oncoscience AG, that a Phase II trial in
children with brain cancer (glioma) utilizing the EGF receptor
monoclonal antibody TheraCIM h-R3 (nimotuzumab, "Theraloc" in
Europe) as a monotherapy achieved a response rate of 35.3%. Six of
the 17 children who were fully evaluable at the time of the
conference were reported to have demonstrated either stable disease
or a partial response. Of the six, four were identified by
investigators to have been suffering from pontine glioma (diffuse
intrinsic brain stem glioma) - a form of the disease that is
particularly aggressive and generally untreatable. No skin toxicity
or allergic reactions were reported, consistent with all the
previous trials conducted with TheraCIM h-R3. |
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Diagnostics and Therapeutics Update |
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IMI provides update on ARISE
clinical trial
Aendments approved last week by the U.S. Foodand Drug Administration
(FDA) to accelerate AtheroGenics, Inc.'s ARISEclinical trial and
increase patient enrollment will provide IMI International Medical
Innovations Inc. (Toronto) with valuable new data on skin sterol and
its relationship to primary events such as heart attacks and stroke
sooner than expected, IMI announced. "We expect ARISE to provide
some of the most exciting data ever collected on skin sterol testing
and early detection of heart disease," said Dr. Brent Norton,
President and Chief Executive Officer. "Previous studies have
demonstrated that skin sterol correlates with the presence and
extent of coronary artery disease and prior heart attack. With data
from ARISE, we may find that skin sterol correlates with primary
cardiac events, such as heart attack, or death. It may also prove to
be an effective tool to monitor patients' response to AtheroGenics,
Inc's novel therapy, AGI-1067." The amendments to ARISE will
accelerate the study and enable IMI to enroll additional patients
for testing with PREVU(*) Point of Care Skin Sterol Test. It will
also further broaden the profile of PREVU(*) POC with leading
cardiologists and cardiac centers in the United States and Canada.
The ARISE study is expected to be completed in the first quarter of
2006.
Axcan Launches CANASA 1000
mg in the U.S.
Axcan
Pharma Inc. (Mont Saint Hilaire) announced the launch of CANASA 1000
mg, the only FDA approved once-daily mesalamine suppository for the
treatment of ulcerative proctitis. Axcan received a three-year
marketing exclusivity for the new dosage form under the non-patent
exclusivity provisions of the Federal Food, Drug and Cosmetic Act.
"The once-a-day CANASA 1000 mg suppository offers a new treatment
option for patients with ulcerative proctitis," said Dr. Miguel
Regueiro, Associate Professor of Medicine and Co-Director of the
Inflammatory Bowel Disease Center at the University of Pittsburgh
Medical Center. "The 1000 mg suppository is as efficacious as the
twice-a-day CANASA 500 mg suppository, but 1000 milligrams once a
day is easier for patients to use and should improve compliance."
Chemokine completes
enrollment in Phase I clinical trial
Chemokine Therapeutics Corp. (Vancouver), a biotechnology company
developing drugs in the field of chemokines and cytokines, today
announced that it has completed enrollment of study subjects and the
administration of its investigational immune recovery drug CTCE-0214
as part of its Phase I clinical trial. The clinical study is being
conducted at a contract clinical research facility in the United
States. The primary objective of the current Phase I study is to
evaluate the safety, pharmacodynamics (action of the drug in the
body), and pharmacokinetic profile (how the drug is metabolized and
excreted) of CTCE-0214. The randomized, double-blind,
placebo-controlled dose-escalation trial was completed with 24
subjects in six dose-escalation groups. The Company and clinical
investigators remain blinded to the study and are in the process of
finalizing collection of data for evaluation. The Company expects
the results of the study to be made available in Q2 of 2005 at which
time the Company will provide an update on the future clinical
development of CTCE-0214.
Research Provides Ways To
Inhibit Cancer's Ability To Resist Treatments
A team
of researchers at the University of Alberta in Edmonton and the
Samuel Lunenfeld Research Institute in Toronto have discovered how a
key enzyme involved in repairing DNA is put together and how it
works--a development that opens up new therapies for making cancer
cells more vulnerable to attack. The team has crystallized--or
characterized in three dimensions--polynucleotide kinase (PNK), a
key enzyme involved in a cell's ability to repair single-strand and
double-strand breaks in DNA. "This gives us a clearer picture of how
the enzyme works and opens up the possibility that we can develop
drugs that inhibit cancer's ability to repair itself and resist
treatments," says Biochemistry professor Mark Glover, the lead
author in the paper published in today's issue of Molecular Cell.
Normally, explains Department of Oncology and Alberta Cancer Board
researcher Michael Weinfeld, when a single- or double-strand break
occurs, "the damaged ends need to be cleaned up before they can be
rejoined" as an early step in the repair process. PNK is one of the
key enzymes required to "polish" the strand break ends. Without it,
cells are more sensitive to agents such as ionizing radiation or
certain drugs that kill cells by damaging their DNA. DNA, or
deoxyribonucleic acid, is a large molecule shaped like a double
helix found primarily in the chromosomes of the cell nucleus and
contains the genetic information of the cell. Once damaged, cells
have developed biochemical responses to repair the damage; when they
can't be repaired, cells die if the damage is too toxic. Or, if the
damage is not lethal, mutations can occur that lead to cancer. The
paper is entitled The Molecular Architecture of the Mammalian DNA
Repair Enzyme, Polynucleotide Kinase. The work builds on Dr.
Weinfeld's work on understanding DNA damage, Dr. Glover's work on
the basic biochemical processes involved in understanding breast
cancer and Dr. Bernstein's postdoctoral work. The research was
funded by the Canadian Institutes of Health Research, the National
Cancer Institute of Canada and the Alberta Heritage Foundation for
Medical Research. Dr. Glover is also a Canada Research Chair.
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Medical Devices |
NIR Diagnostics completes supply agreement for HemoNIR(TM)
NIR Diagnostics Inc. (Campbellville), an innovative developer of
near-infrared handheld reagentless medical instruments, announced
that it has successfully concluded a supply agreement with
Boehringer Ingelheim microParts GmbH based in Germany. MicroParts
will supply their microspectrometers for the manufacture of the
portable and reagentless co-oximeter HemoNIR(TM) device. NIR
Diagnostics has worked closely with microParts over the past year in
the development of the HemoNIR(TM) product. "We are very excited
about using our microspectrometer technology in the HemoNIR(TM) co-oximeter
instrument and look forward to expanding our business relationship
with NIR Diagnostics to further products based on our spectral
sensors," said Dr. Ralf-Peter Peters, Director Microfluidics
Division, Boehringer Ingelheim microParts. NIR Diagnostics is
developing a range of other near-infrared spectroscopic products
including CardioNIR(TM), to measure total cholesterol, and
GlucoNIR(TM), to measure glucose. |
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Genomic Update |
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Industry Briefs |
- Isotechnika Inc. (Edmonton) announced the appointment of
David Wingnean M.D., M.B.A. to Senior Vice President of Medical
Affairs and Corporate Communications…….
- Cardiome Pharma Corp. (Vancouver) announced that it has
filed a short form preliminary base PREP prospectus with the
Canadian securities regulators and a registration statement with
the U.S. Securities and Exchange Commission in connection with
an offering of 8,500,000 common shares. In connection with this
offering, Cardiome plans to grant to the underwriters a 30-day
option to purchase up to an additional 1,275,000 common shares
to cover over-allotments, if any. All of the shares will be
offered by the company and will consist of newly issued common
shares. The offering is expected to be made primarily in the
United States……..
- IMI International Medical Innovations Inc. (Toronto)
announced that it has filed a new patent application with the
United States Patent and Trademark Office (PTO) related to a new
format of PREVU Skin Sterol Test. This patent, titled Method and
Apparatus for Non-Invasive Measurement of Skin Tissue
Cholesterol, further establishes IMI's leadership in
non-invasive cardiovascular disease risk assessment. The patent
covers the method of measuring skin sterol as well as the format
of the test…….
- MedMira Inc., (Halifax) the global market leader in rapid
flow-through diagnostic technology, announced that it had
presented its MiraCare(TM) rapid, over-the-counter (OTC) test to
participants of an international HIV diagnostics conference
hosted by the United States Centers for Disease Control (CDC).
The conference, entitled "HIV Diagnostics: New Developments and
Challenges", was attended by HIV-diagnostic healthcare personnel
from the private and public health sectors situated around the
world……
- Procyon Biopharma Inc. (Montreal) announced that it has
entered into a licensing and distribution agreement with
Medicorp Inc. granting the latter the exclusive worldwide rights
to develop, manufacture and commercialize PSP94-based test kits
for research purposes as well as the rights to sub-license for
clinical diagnostic applications……
- A spreva Pharmaceuticals Corporation (Victoria) announced
the initial public offering of 7,200,000 shares of its common
shares at a price of US$11.00 (C$13.68) per share……
- Labopharm Inc. (Laval) announced that its European
subsidiary, Labopharm Europe Limited, has amended its licensing
and distribution agreement with Austria-based CSC
Pharmaceuticals Handels GmbH for once-daily tramadol to include
Russia. The amendment increases the number of countries covered
by the agreement to 15…….
- Theratechnologies (Montreal) announced the appointment of
James W. Sutton, M.D., as Vice President, Clinical Development
and Regulatory Affairs. Dr. Sutton will oversee all preclinical,
clinical and regulatory activities of the Company. This
appointment will take effect on March 7, 2005……. ID Biomedical
Corporation (Vancouver) announced that it has closed the
transactions with Alexandria Real Estate Equities, Inc. (NYSE:
ARE) for the sale and leaseback of two ID Biomedical facilities:
the newly constructed Vaccine Research Centre in Laval, Quebec,
Canada; and a vaccine development facility in Northborough,
Massachusetts, U.S. The total purchase price paid at closing to
ID Biomedical is approximately CAD $50 million. All conditions
precedent to these transactions have now been satisfied……
- Neurochem Inc. (Montreal) announced that its registration
statement has become effective under the U.S. Securities Act of
1933 and that it has obtained a receipt for a final prospectus
from each of the provinces of Canada in connection with its
public offering of 4 million common shares. The common shares
will be sold in the United States and Canada at US$15.30 per
share and all common shares will be offered by the company. The
total gross proceeds to the company will be approximately
US$61.2 million. The offering is expected to close on or about
March 9, 2005.
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(Life Sciences News Briefs © 2004 is prepared by Armar International for
the Life Sciences Branch of Industry Canada (contact: Sandy Vien; Tel:
613-941-6479; E-mail: vien.sandy@ic.gc.ca).
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