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Life Sciences News Brief
Vol. 4 no. 44 - January 26, 2005
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Pharmaceuticals Update |
Labopharm receives notification of approval in France for tramadol
Labopharm Inc. (Laval) announced that it has received notification
of regulatory approval for its once-daily formulation of tramadol
from the French regulatory authority. The product has been approved
with a once-daily designation for use in a dose range from 100 to
400 mg per day in the treatment of moderate to severe pain. Approval
in France allows Labopharm to initiate the Mutual Recognition
Procedure (MRP) in pursuit of regulatory approval for the remainder
of the European Union countries.
Procyon Reports Fibrostat(R) Phase IIb Results
Procyon Biopharma Inc. (Montreal) announced preliminary results for
its North American placebo-controlled, double-blind, randomized
Phase IIb clinical trial with Fibrostat(R). The results indicate
that although Fibrostat(R) was safe and well tolerated, the primary
endpoint of efficacy was not reached. Analysis of the primary
efficacy endpoint showed no overall significant improvement with
Fibrostat(R) as compared to the placebo-treated group. A sub-group
analysis of scars with a baseline Manchester Scar Scale value equal
to or greater than 13 however suggests a potential for efficacy in
the more severe scars (n=27; p=0.088). There appears to be a
definite trend of efficacy amongst the more severe scars as
indicated by a significant baseline-dose interaction (p=0.017). This
observation is similar to that obtained in the earlier Phase IIa
trial. Drug-related adverse events (acne and rash) were observed in
only two out of the 62 Fibrostat(R)-treated patients while there
were no related serious adverse events in this group. A final report
on the complete analysis of the data will be available in March
2005.
Adherex Technologies Initiates Phase Ib/II Exherin(TM) Trial In
Europe
Adherex Technologies Inc. (Ottawa), a biopharmaceutical company with
a broad portfolio of oncology products under development, announced
that it has received regulatory approval from Swiss Medic to
initiate a Phase Ib/II clinical trial of its lead angiolytic
compound Exherin(TM) in advanced cancer patients who express the
tumor molecular target N-cadherin. This study is the first in which
the Company will explore weekly dosing. The study will also utilize
dynamic MRI imaging to monitor the drug's effect
FDA Issues Not Approvable Letter For INEX Marqibo(TM)
Inex Pharmaceuticals Corporation (Vancouver) announced that United
States Food and Drug Administration (FDA) provided an action letter
detailing that the anticancer drug Marqibo(TM) (vincristine sulfate
liposomes injection) is "not approvable" under the FDA's accelerated
approval regulations based on the phase 2 clinical trial data
submitted. INEX said the FDA "not approvable" decision was expected
after the FDA's Oncologic Drugs Advisory Committee (ODAC) voted
December 1, 2004 against recommending accelerated approval for
Marqibo as a treatment for patients with relapsed aggressive
non-Hodgkin's lymphoma (NHL) based on the phase 2 clinical trial
data and comparison to available therapy. |
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Diagnostics and Therapeutics Update |
AEterna Zentaris Advances AN-152 Targeted Anti-Cancer Agent
AEterna Zentaris Inc. (Quebec City) announced the initiation of a
company-sponsored Phase I dose-ranging study for its targeted
anti-cancer agent AN-152, a novel cytotoxic conjugate which has the
potential to selectively and specifically target certain types of
cancer cells that express Luteinizing Hormone Releasing Hormones (LHRH)
receptors (LHRH receptor positive tumors) and thereby may offer a
better safety and efficacy profile as compared to the cytotoxic
agent alone. The Phase I study, which will be conducted at
university clinics in Gottingen and Frankfurt/Main in Germany, will
evaluate the safety (including maximum tolerated dose and
dose-limiting toxicity) and pharmacokinetics of
intravenously-administered AN-152 in patients with LHRH receptor
positive ovarian, endometrial or breast cancer. A high percentage of
these cancers, in addition to hormone-refractory prostate cancer,
are known to be LHRH receptor positive and, therefore, represent
logical initial indications for AN-152.
BioMep raises more than $19 million, becomes Enobia Pharma
BioMep (Montreal) (Enobia Pharma), a privately held biotechnology
company specializing in the development of solutions for
enzyme-replacement therapy and the treatment of bone diseases,
announced the completion of a third round of private financing,
raising more than $19 million CAN. Desjardins Venture Capital became
a new financial partner, joining the Fonds de solidariti FTQ,
T2C2/Bio 2000 (a limited partnership) and Innovatech Montreal, which
has also taken part in financing the company. Since its creation, in
1997, and with its latest round, BioMep (Enobia Pharma) has raised
more than $29 million CAN in private venture capital.
ID Biomedical begins development of pandemic influenza vaccine
ID Biomedical Corporation (Vancouver) announced that it has begun
development of an experimental ("mock") vaccine against a strain of
the influenza virus, H5N1, that experts believe could cause a deadly
worldwide epidemic (pandemic) of influenza. The H5N1 strain is a new
strain of influenza virus that humans have little or no resistance
to and has resulted in high rates of illness and death. ID
Biomedical's development efforts will concentrate on creating a
vaccine using a genetically modified variant of the H5N1 strain |
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Medical Devices |
Advanced Sterilization Products introduces STERRAD(R) NX
Advanced Sterilization Products (Markham), a leading developer of
instrument processing technologies, announced the Canadian launch of
the STERRAD(R) NX Sterilization System, its next-generation
low-temperature hydrogen peroxide gas plasma sterilizer for rapid
processing of medical devices and surgical instruments. The STERRAD
NX System, with a 28-minute standard processing time that is
significantly faster than that of any other STERRAD System, helps
hospitals improve instrument utilization and reduce costs - key
benefits in today's healthcare environment. While 90-95 percent of
instruments can be processed in the standard cycle, a 38-minute
advanced cycle time also is available for single-channel flexible
endoscopes and tubing, and devices with long, narrow lumens.
Angiotech partner is first with next-generation drug-eluting
stent system
Angiotech Pharmaceuticals, Inc. (Vancouver) corporate partner,
Boston Scientific announced that Boston has launched its TAXUS(TM)
Liberte(TM) paclitaxel-eluting coronary stent system in 18
countries. The TAXUS Liberte stent system features Boston
Scientific's next-generation Liberte(TM) coronary stent. The Liberte
stent features the Veriflex(TM) stent design, a highly flexible cell
geometry with thin struts and uniform cell distribution. This new
platform offers improved deliverability and conformability in
challenging anatomy. It also features the enhanced TrakTip(TM)
catheter tip, mounted on the Maverick2(TM) delivery catheter, which
provides better lesion crossability. In addition, TrakTip has a low
lesion-entry profile, which further improves crossability, as stated
by Boston.
CryoCath Reports Strong Chronic AF Results
CryoCath Technologies Inc. (Montreal), the global leader in
cryotherapy products to treat cardiovascular disease, announced that
Dr. Vivek Reddy, M.D. of the Massachusetts General Hospital
presented additional data on a human feasibility study using the
Company's proprietary Arctic Circler Balloon catheter to treat
Atrial Fibrillation (AF). The data was presented at the Boston
Atrial Fibrillation Symposium held at the Seaport Hotel and
Conference Center, in Boston, on Saturday January 15th 2005. Of the
16 patients who have now reached the 6-month follow-up point, 13 are
AF-free, with 11 off specific anti-arrhythmic drugs. Of the three
patients who were technically deemed "treatment failures", one was
retreated and is AF-free; and the other two are both off drugs, have
had a significant reduction in burden, and have conditions that do
not warrant re-treatment and are considered clinically successful.
There have been no device-related serious adverse events such as
stenosis, stroke or esophageal perforation. There were two reports
of asymptomatic transient phrenic nerve palsy with no clinical
sequalae. The first patient has fully recovered while the second
patient has almost fully recovered at six-month follow-up. |
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Genomic Update |
B.C. Team Maps Genome Of Disease-Causing Fungus
Scientists at the University of British Columbia have mapped the
genome of a fungus that causes meningitis, which could lead to
better treatments. People with AIDS and others with compromised
immune systems are especially vulnerable to the Cryptococcus fungus.
The research could eventually lead to better anti-fungal drugs,
vaccines for fungal meningitis and faster diagnostic tests, said UBC
microbiologist Jim Kronstad, the lead researcher on the project.
Kronstad said 10 to 30 per cent of AIDS patients contract a fungal
infection, about 45 million cases around the world. Current
anti-fungal drugs must be taken over several months to be effective.
Cryptococcus spores are found in soil contaminated with pigeon
droppings and in trees. Inhaling the spores can infect a person. The
study sequencing the genetic code of two forms of the Cryptococcus
fungus has been going on for three years. It's part of a five-part
project that began nine years ago. The team of scientists has almost
finished sequencing the genome of a third form of the fungus,
Cryptococcus neoformans gattii, the form that has caused disease
recently in Canada. |
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Industry Briefs |
- Chromos Molecular Systems Inc. (Burnaby) announced that it
has completed the private placement of 2,215,085 units at $0.48
per share for total gross proceeds of $1,063,241. Each unit
consists of one common share and one-half on one common share
purchase warrant. Each whole warrant will entitle the holder to
purchase one additional Common Share of the Company at a price
of $0.60 for a period of 24 months from the closing date of the
private placement. The proceeds will be used to fund the
on-going development of the Company's cellular engineering and
cell therapy programs and for general working capital
purposes…..
- Stem Cell Therapeutics Corp. (Calgary) announced that the
U.S. Patent and Trademark Office has granted U.S. Patent Number
6,844,312 to the company's wholly-owned subsidiary, Stem Cell
Therapeutics Inc. Stem Cell Therapeutics Inc. was acquired by
Stem Cell Therapeutics Corp. from Transition Therapeutics (TSX:
TTH) as previously announced on October 5, 2004…..
- Bioxel Pharma Inc. (Sainte-Foy), a leading manufacturer of
naturally derived taxanes and targeted oncology drugs, announced
the appointment of Mr. Pascal Delmas as President and Chief
Executive Officer of the Corporation, replacing Dr. Pierre
Lacroix who is stepping down as President to retire……
- Altachem Pharma Ltd. (Edmonton) announced that Dr. David J.
Cox has been appointed as the President and Chief Executive
Officer of the Company effective February 1, 2005. Dr. Cox will
also be joining the Company's board as one of its directors…..
- MedMira Inc., (Halifax) the global market leader in rapid
flow-through diagnostic technology, announced that the results
of the 2004 U.S. CDC (Centers for Disease Control and
Prevention) HIV Rapid Testing performance evaluation showed that
MedMira's Reveal(TM) Rapid HIV-1 Antibody Test (Reveal(TM))
remains the test of choice in U.S. hospitals for the second
consecutive year……
- Biophage Pharma Inc. (Montreal) announced the appointment of
Bruce Schmidt to interim Chief Financial Officer, to replace
Lucie St-Georges who is leaving Biophage as of January 28, 2005
in order to pursue other career opportunities…..
- LAB International Inc. (Laval), an integrated drug
development company focused on the inhalation market, announced
that it has closed two additional private placement transactions
for gross proceeds of $2.4 million through the sale of 2.25
million units at $1.05 per unit primarily to European investors
and LAB management. Each unit issued consists of one share and
one half of a share purchase warrant. Each whole warrant will
entitle the holder to purchase one share at a price of $1.45 at
any time until December 30, 2006. The shares issued and shares
to be issued pursuant to the exercise of the warrants will be
subject to a four-month hold from the closing date. These
transactions complete the Company's previously announced private
placement financings, bringing the total amount raised to $9.6
million…..
- TOPIGEN, (Montreal) a biotechnology company engaged in
scientific research and development of novel therapeutic drugs
for asthma, allergic rhinitis and other respiratory diseases,
announced today the appointment of Dr. Louise Proulx, Ph.D., as
Vice President, Product Development….. Haemacure Corporation
(Montreal) announced that it has received payment of US$1
million from Baxter Healthcare S.A. ("Baxter"), as per the terms
of the October 2003 Settlement, Termination and Release
Agreement with Baxter providing for the termination of the
Hemaseel APR fibrin sealant license and supply agreements….
- Angiotech Pharmaceuticals, Inc. (Vancouver) corporate
partner, Boston Scientific announced the implantation of its
millionth TAXUS(R) Express2(TM) paclitaxel-eluting coronary
stent system, marking a major milestone for Boston Scientific
and for the treatment of coronary artery disease.
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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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