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Life Sciences News Brief
Vol. 6 no. 05 - March 15, 2006
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Pharmaceuticals Update |
Patent Issues on ARIUS Lead Antibody
ARIUS Research Inc. (Toronto) announced that it
has received notice from the United States Patent and Trademark
Office that U.S. patent No. 7,009,040 was issued on March 7, 2006
for ARIUS' lead anti-CD63 antibody, AR7BD-33-11A. Previously ARIUS
announced that it had received a Notice of Allowance in October
2005. The patent covers the antibody molecule, various uses of the
antibody, its derivatives, and a method for using it, and other
similar antibodies, to treat cancers such as prostate and breast
cancer. ARIUS has several additional patent applications pending
that will continue to enhance the value of this and other important
antibody assets. AR7BD-33-11A is one of a series of anti-CD63
antibodies generated through ARIUS' proprietary FunctionFIRST(TM)
product platform. ARIUS has shown that antibodies directed against
the CD63 target have a significant impact on cancers such as human
pancreatic cancer, melanoma, breast and prostate cancers. Due to its
potency, and other desirable characteristics, AR7BD-33-11A was
selected as a lead antibody and humanized to make it suitable for
human clinical trials. http://www.ariusresearch.com
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Clinical Trials |
BioMS Medical's MBP8298 shows
five-year delay of disease progression
BioMS Medical Corp
(Edmonton), a leading developer in the treatment of multiple
sclerosis (MS), announced that its proprietary drug candidate
MBP8298 delayed disease progression for five years in progressive MS
patients with HLA-DR2 or HLA-DR4 immune response genes. Treatment
and follow-up of patients from a phase II clinical study
demonstrated that patients in this DR2 and DR4 responder group, who
comprise up to 75% of MS patients, had a median time to disease
progression (worsening) of 78 months compared to 18 months for
patients who received placebo. "These results show an unprecedented
5-year improvement in time to disease progression in the majority of
progressive MS patients," said Kevin Giese, President and CEO of
BioMS Medical. "Pending confirmation of these results in our ongoing
international pivotal trial in secondary progressive MS, we
anticipate that MBP8298 will represent a novel first in class
treatment for MS patients." The findings are based on a two-year
treatment and five-year follow-on study conducted and analyzed by
the University of Alberta and BioMS Medical. The primary objective
of the trial was to assess the clinical efficacy of 500mg of MBP8298
administrated intravenously every six months, as measured by the
Expanded Disability Status Scale (EDSS). Long-term follow-up
treatment and assessment of 20 progressive MS patients with the
HLA-DR2 or HLA-DR4 immune response genes demonstrated a median time
to progression of 78 months (6.5 years) for MBP8298 treated patients
compared to 18 months (1.5 years) for patients treated with placebo
in the initial study (Kaplan-Meier analysis, p equals 0.004).
http://www.biomsmedical.com
Liponex Receives Approval to Initiate
CRD5 Clinical Trial
Liponex Inc. (OTTAWA), a
biopharmaceutical company specializing in developing advanced
products related to High Density Lipoprotein (HDL), often called
"good cholesterol," announced that it has received Health Canada
approval to initiate a clinical trial in a patient population using
a new formulation of its lead pharmaceutical product, CRD5, being
developed for the treatment and prevention of heart disease. The
Phase I/II dose-ranging trial will take place at a leading Canadian
academic health sciences centre, and will involve 50 dyslipidemic
patients (patients with low HDL and high LDL). Following dietary
lead in, patients will be given daily doses of the latest
formulation of CRD5 in capsule form. The treatment period for each
patient will be 12 weeks. The primary endpoints for the trial are
safety and an increase in serum HDL, with triglyceride and LDL
reductions as secondary endpoints. The results of this trial will be
used to determine an optimal dose for use in subsequent trials to
confirm the efficacy of CRD5 in larger patient populations. http://www.liponex.ca
Stem Cell Therapeutic Announces
Interim Preclinical Data
Stem Cell Therapeutics
Corp. (Calgary) announced interim results from a key preclinical
study of NTx(TM)-265 therapy for the treatment of stroke. This study
utilized a clinically relevant model of stroke to validate the
NTx(TM)-265 dose, timing and regimen anticipated for SCT's proposed
Phase IIa study. In addition, these results have been accepted for
poster presentation at the upcoming European Stroke Conference to be
held May 16-19, 2006, in Brussels, Belgium. The results of this
independently conducted, blinded, placebo-controlled six week study
demonstrate a substantial and significant recovery of motor function
following NTx(TM)-265 administration in the rat middle cerebral
artery model of stroke. NTx(TM)-265 therapy initiated 24 hours after
stroke significantly (p=0.0001) improved composite neurological
motor scores in rats compared to control animals that received
saline treatment. In addition, these findings support the premise
that the therapeutic window for initiation of NTx(TM)-265
administration extends beyond the restrictive 3 hour window for
thrombolytic therapies to a more clinically feasible treatment time
of at least 24 hours following onset of stroke. Notably, the study
was designed to simulate the clinical protocol expected for the
Company's proposed Phase IIa evaluation of NTx(TM)-265. http://www.stemcellthera.com
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Diagnostics and Therapeutics Update |
Angiotech partner submits final
module for TAXUS(R) Liberté(TM)
Angiotech Pharmaceuticals,
Inc. (Vancouver) announced that its corporate partner Boston
Scientific Corporation has submitted to the U.S. Food and Drug
Administration (FDA) the final module of BSC's Pre-Market Approval (PMA)
application for its TAXUS(R) Liberté(TM) paclitaxel-eluting coronary
stent system. The TAXUS Liberté system is BSC's next-generation
drug-eluting stent system. The third and final PMA module contains
nine-month data from the ATLAS clinical trial, a global,
multi-center, pivotal study designed to support FDA approval of the
TAXUS Liberté system in the United States. Pre-Market Approval is
the FDA process of scientific and regulatory review to evaluate the
safety and efficacy of Class III medical devices prior to approval
to market a device in the United States. http://www.angiotech.com
Sentinel Principle(TM) paper
published in Journal
ChondroGene Limited
(Toronto) announced that a paper entitled "Peripheral blood
transcriptome dynamically reflects system wide biology: a potential
diagnostic tool," authored by ChondroGene scientists C.C. Liew, J.
Ma, H.C. Tang, R. Zheng, and A.A. Dempsey, was published in the most
recent issue of the Journal of Laboratory and Clinical Medicine, a
peer-reviewed, internationally recognized journal dedicated to
advances in the field. The results presented in the paper
demonstrate that ChondroGene's proprietary Sentinel Principle (TM)
can be used to detect tissue specific gene transcripts in peripheral
blood that relate to gene expression in tissue. Approximately 80% of
the genes expressed in the tissues studied were also identified in
blood. Nine different tissue types were examined in the study -
brain, colon, heart, kidney, liver, lung, prostate, spleen, and
stomach. The ability to identify gene expression in blood that is
related to gene expression in specific tissues, the essence of the
Sentinel Principle, forms the basis of the Company's blood-based
molecular diagnostic tests currently in development. Although the
Company has previously published papers reporting results in
specific diseases using the Sentinel Principle, this is the first
article detailing the utility of applying the Sentinel Principle
across a broad range of human diseases. http://www.chondrogene.com
Canadian claims to have developed
world's first blood test for brain diseases
A Canadian neuroscientist claimed to have developed
the world's first simple blood test to detect brain diseases such as
Alzheimer's, Parkinson's and Creutzfeldt-Jakob disease and says it
may be available within two to five years. The test, which looks for
clumps of "misfolded" proteins that underlie such diseases, will
enable a "definitive diagnosis" of such illnesses, which is not
currently possible, researcher Neil Cashman told AFP. Cashman's
research was backed by the Canadian Institutes of Health Research, a
government agency. (http://www.cihr.ca) His new company Amorfix Life
Sciences Inc. hopes to complete clinical trials to diagnose mad cow
disease (Bovine Spongiform Encephalopathy) and its human form, new
variant Creutzfeldt-Jakob disease, within six months. Cashman said
the tests will allow doctors to treat patients earlier when remedies
are more likely to be effective. Currently, doctors must rely on
complex cognitive and memory tests, invasive spinal taps or
expensive imaging tests to diagnose brain diseases and only
post-mortem examinations have been conclusive until now. "Brain
diseases produce a lot of symptoms. They're tragic, untreatable,
incurable diseases, but in order to make a definitive diagnosis, you
require a piece of brain under the microscope," Cashman said. "This
is not a group of diseases that you could find abnormal cells like
Leukemia. These are diseases that occur inside the skull, so even
the best clinicians and diagnosticians are only right 80 to 90
percent of the time," he said. Because diagnosis is so difficult,
most drugs are now dispensed when the disease is well into its
course. "If we had something as of the first month of Alzheimer's
disease symptoms, it's likely that Aricept and similar medicines
would have a greater effect on the progression of the disease,"
Cashman said. At present, there is no cure for Alzheimer's, but
there are treatments (such as donepezil, marketed under the name
Aricept) aimed at mitigating the disease. Cashman said clinical
trials for his new treatments are ongoing. "If all goes perfectly,"
tests for these diseases would be available within two years, he
said. Tests for Alzheimer's, Amyotrophic Lateral Sclerosis (ALS),
commonly known as Lou Gehrig's disease, and others will take up to
five years, he said. http://www.amorfix.com |
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Medical Devices |
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Genomic Update |
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Industry Briefs |
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QLT Inc.
(Vancouver) announced its intention to appeal the decision of
the U.S. District Court for the Northern District of Illinois
Eastern Division, granting an injunction enjoining QLT,
Sanofi-aventis and their subsidiaries from promoting,
manufacturing, selling and offering for sale QLT USA, Inc.'s
Eligard(R) product in the United States until May 1, 2006. The
Court further ordered QLT and Sanofi-Synthelabo to recall any
Eligard products that they still own and provide a voluntary
recall program to allow physicians, wholesalers and
distributors, who wish to do so, to return Eligard for a full
refund. http://www.qltinc.com
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AnorMED Inc.
(Vancouver) has responded to a letter from Felix J. Baker
contained in a filing of a further amendment, made February 23,
2006, to a Schedule 13D filing with the United States Securities
and Exchange Commission by Felix J. Baker and Julian C. Baker. A
copy of Mr. Scott's response can be found on the Company's
website at http://www.anormed.com
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QLT Inc.
(Vancouver) announced that it has appointed Robert Butchofsky as
President and Chief Executive Officer and as a Director of the
Board. The Board also named C. Boyd Clarke as the new Chairman.
Both of these appointments are effective immediately. Past
Chairman E. Duff Scott will remain as a Director of the Board.
http://www.qltinc.com
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ARIUS Research Inc.
(Toronto) announced that it has closed the second and final
tranche of its previously announced private placement of common
shares and share purchase warrants for additional gross proceeds
of US$1.2 million. The terms of the offering were disclosed on
closing of the first tranche, which was announced on March 1.
With the completion of this financing, the Company has raised
total gross proceeds of US$22.7 million. http://www.ariusresearch.com
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Amorfix Life Sciences
(Toronto) announced that it has entered into an agreement with
Blackmont Capital Inc. as its Agent for an equity private
placement, to proceed on a best efforts basis at a price of
$0.85 per share for a minimum of $2,000,000 and a maximum of
$3,000,000. In addition, the Agent has been granted a 15%
over-allotment option, which may increase the financing to a
total of $3,450,000. Insiders of the company will be
participating in the issue. http://www.amorfix.com
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Cardiome Pharma Corp.
(Vancouver) announced the promotion of Doug Janzen to the
position of President and Chief Business Officer. Mr. Janzen for
three years prior to this appointment has been Cardiome's Chief
Financial Officer. Bob Rieder will continue in his role as Chief
Executive Officer and has been appointed Vice-Chairman of the
board of directors. Dr. Mark Rogers will continue as Chairman.
http://www.cardiome.com
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Neuromed Pharmaceuticals
(Vancouver), a biopharmaceutical company
developing next-generation chronic pain drugs, announced the
completion of a Series D financing of US$25 million. This fourth
round of financing brings Neuromed's cumulative venture capital
financing to US$74 million. htttp://www.neuromed.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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