Life Science News Briefs Vol. 5 no.44 - January 25, 2006

• Pharmaceuticals Update
• Diagnostics and Therapeutics Update
• Medical Devices Update
• Industry Briefs
  

Pharmaceuticals Update

Chemokine Therapeutics to present new data on its lead anti cancer drug

Chemokine Therapeutics Corp. (Vancouver), a biotechnology company developing drugs in the field of chemokines, announced that the 2006 Miami Biotechnology Winter Conference on Angiogenesis in Cancer and Vascular Disease has accepted the results of a research study of Chemokine Therapeutics' first lead drug candidate, CTCE-9908, for public presentation. The presentation, entitled "The CXCR4 Antagonist CTCE-9908 Inhibits SDF-1-Induced Angiogenesis", will be presented on Tuesday February 7th in Miami, FL. It has been demonstrated that the chemokine SDF-1 is critical for both the migration and attachment of cancer cells to normal tissue and the formation of new blood vessels needed to provide nutrients to cancer cells. Chemokine Therapeutics has designed CTCE-9908, an inhibitor of SDF-1, to block the spread of certain common cancers by inhibiting their metastasis and growth. In summary, Chemokine Scientists have discovered that CTCE-9908 has exhibited potent anti-angiogenic activity, thus preventing the formation of blood vessels needed for blood supply to new tumors. The new results suggest that CTCE-9908 may also affect cancer growth by interrupting blood supply to tumors.

Nuvo sells rights, announces Phase III results

Nuvo Research Inc. (Markham) and Paladin Labs Inc. (Montreal) jointly announced that they have entered into an agreement which expands their relationship with respect to the sale and marketing of Pennsaid(R) in Canada. In August 2005, Squire Pharmaceuticals Inc. (formerly Dimethaid Health Care Ltd.) was acquired by Paladin from Nuvo. The terms of this expanded agreement include Squire making an up-front payment, providing on-going royalties on the sale of Pennsaid(R) and making an investment of $500,000 in Nuvo through a three-year debenture convertible into Nuvo shares at a conversion price of $0.456, which is based on the ten-day average closing price. Nuvo also announced detailed positive results of its Phase III Clinical Trial ("Study 112") of Pennsaid(R), a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis. Pennsaid(R) is currently approved for sale in Canada and several European countries. The trial was designed with the advice and recommendations provided by the U.S. Food and Drug Administration (FDA) to address specific deficiencies identified in the FDA non-approvable letter received by Nuvo in August 2002. The trial results confirm the efficacy of Pennsaid(R) that has been demonstrated in Nuvo's prior Phase III trials.

Protox receives FDA clearance to begin Phase I prostate cancer trial

Protox Therapeutics Inc. (Vancouver) announced that the Investigational New Drug (IND) application for PRX302, the Company's lead product for the treatment of recurrent localized prostate cancer, has been cleared by the US Food and Drug Administration (FDA). As reported previously, the IND application was filed in December, 2005 and its clearance means that the Company may now proceed with the initiation of its Phase I clinical trial. PRX302 is the first of a novel class of targeted prodrugs based on the Company's PORxin(TM) platform. It is a therapeutic pore-forming toxin designed to be activated by prostate specific antigen (PSA), an enzyme which is produced and is active only in the prostate.

Biovail Receives Approval for Wellbutrin(R) XL to Treat Depression

Biovail Corporation (Toronto) announced that the Therapeutic Products Directorate Canada (TPD) has issued a Notice of Compliance (NOC) for 150mg and 300mg tablet strengths of Wellbutrin(R) XL, a once-daily, extended-release formulation of bupropion hydrochloride (HCl) for the treatment of major depressive illness in adults. Upon launch, Wellbutrin(R) XL will be the first and only once-daily formulation of bupropion available in Canada. Biovail Pharmaceuticals Canada (BPC), Biovail's Canadian sales and marketing division, will introduce the features and benefits of Wellbutrin(R) XL to health-care professionals throughout Canada. BPC anticipates launching Wellbutrin(R) XL late in the first quarter of 2006.

Diagnostics and Therapeutics Update

Independent Evaluations of Response Biomedical's RAMP Flu A Test

Response Biomedical Corp. (Vancouver) announced that initial evaluations performed by independent public health organizations demonstrated that the Company's rapid RAMP Flu A Test had significantly greater sensitivity than existing point-of-care diagnostic products. The Company now plans to initiate multi-center clinical trials of its RAMP Flu A and Flu B Tests during the current flu season. "The RAMP Flu A Test has consistently demonstrated sensitivity that is of an order of magnitude higher than available rapid tests," said Dr. Paul C. Harris, Vice President, Research and Development. "This superior level of sensitivity was also observed in detecting the H5N1 strain of Avian Flu, which provides confidence RAMP will be a clinically valuable diagnostic tool for both human and animal testing."

Oncolytics Announces Commencement Of Solicitation Process

Oncolytics Biotech Inc. (Calgary) announced that the Cancer Therapy Evaluation Program (CTEP), part of the U.S. National Cancer Institute, has issued a solicitation for Letters of Intent with respect to the conduct of two human clinical trials using REOLYSIN(R), a proprietary formulation of the human reovirus being developed as a potential cancer therapeutic. CTEP is soliciting proposals for a Phase II study of REOLYSIN(R) administered systemically in patients with melanoma. The dosage and dosing regimen to be used in the study will be determined based on data derived from ongoing U.K. and U.S. Phase I systemic administration studies being conducted by Oncolytics. CTEP is also soliciting proposals for a Phase I/II study of REOLYSIN(R) co-administered both systemically and intraperitoneally (IP) in patients with ovarian cancer. The purpose of the Phase I portion of the trial is to determine the Maximum Tolerated Dose (MTD) of REOLYSIN(R) given by IP administration in combination with a constant systemic dose and dosing regimen.

Caprion Pharmaceuticals Announces Biomarker Discovery Collaboration

Caprion Pharmaceuticals Inc. (Montreal) announced an additional research collaboration with ICOS Corporation. The new agreement in biomarker discovery will use Caprion's CellCarta(R) proteomics discovery platform. Caprion will identify pharmacodynamic markers in plasma relating to ICOS' pre-clinical oncology programs. Caprion's proprietary proteomics platform comprehensively profiles the expression and identity of proteins detected in tissues and blood plasma. Caprion is presently conducting biomarker discovery programs in other indications for several pharmaceutical and biotechnology companies.

Medical Devices

Toxin Alert Inc. obtains approval for Toxin Guard(TM) in Canada

Toxin Alert Inc. (Toronto) announced that it has received a letter from the Canadian Food Inspection Agency stating that the Toxin Guard(TM) product has met all of the regulatory requirements of the Government of Canada for food packaging. This letter enables Toxin Alert to produce home storage bags that are considered safe, and it allows packaging producers to safely use Toxin Guard(TM) on their printing and other equipment for development purposes and trial runs. Toxin Alert plans to produce home storage bags with Toxin Guard(TM) freshness indicators in the United States, and market them in Canada and the U.S. Toxin Alert is a biotechnology company dedicated to bringing its Toxin Guard(TM) technology to market. Toxin Guard(TM) is a patented system of placing antibody-based tests on polymer packaging films to detect pathogens or other selected micro organisms. The company aims to leverage its patented technology into a commercialized food safety product.

CryoCath Reports Positive Data at Atrial Fibrillation Conference

CryoCath Technologies Inc. (Montreal) the global leader in cryotherapy products to treat cardiovascular disease, announced that Dr. Douglas Packer, from Mayo Clinic, presented additional data from the feasibility stage of the Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF) investigational device exemption (IDE) study using the Company's proprietary Arctic Front catheter to treat Atrial Fibrillation (AF). The data was presented at the preeminent 11th Annual International Boston Atrial Fibrillation Symposium, the only global conference focused solely on the treatment of AF. Dr. Packer reported data on two sets of Arctic Front patient data. Firstly, he reviewed the 12-month data from the original 20 patient European trial which saw 84% of patients AF-free (a further 10% or 2 more patients had significant reductions in AF burden and have conditions that do not warrant re-treatment and are considered clinically successful). Secondly, he reported on early data from 15 patients treated in the feasibility stage of the STOP AF trial who have now reached a minimum 3-month follow up point. Thirteen patients are now AF free (87%), one has been retreated, and one other scheduled to be retreated (one retreatment is consistent with the study's protocol). There were no reported permanent serious device-related adverse events such as stenosis, stroke, esophageal fistula or permanent phrenic nerve injury.

Maple Biosciences Launched, Delivering MedMira Inc. (MIR.V) Excellence

Maple Biosciences (Toronto), a new division of public Canadian company and the global leader in premium rapid diagnostics, MedMira Inc. (MedMira), was officially launched in Toronto. Maple Biosciences will bring to market the next evolution in diagnostic instruments that will displace enzyme linked immunoassays (EIA), a 30 year old technology currently used to conduct routine lab tests in hospitals, laboratories, and clinics around the world. Maple Biosciences' solutions will be among some of the world's most advanced healthcare tools, directly impacting and improving the delivery of healthcare services and the patient experience. The key benefits that Maple Biosciences diagnostics instruments will bring to healthcare providers is increased lab automation, including fewer hands-on steps, a high through-put format, and digital presentation of results. These are key features that help to deal with labour shortages and stretch decreasing healthcare dollars further in an already overtaxed system.

Industry Briefs

NIR Diagnostics Inc. (Campbellville), a leading-edge developer of handheld spectroscopy based medical instruments, announced it has completed its financing agreement with Wolverton Securities Ltd. Under the final tranche of the agreement the Company issued 3,715 secured convertible redeemable debentures at a price of $100 for gross proceeds of $371,500. This brings the total gross proceeds raised from the agreement to $1,205,900. Under the first tranche of the agreement, the Company issued 8,344 secured convertible redeemable debentures at a price of $100 for gross proceeds of $834,400, as announced on December 21, 2005……… QLT Inc. (Vancouver) reported that its alliance partner, Novartis, announced global Visudyne(R) (verteporfin) sales of approximately US$108 million for the quarter and US$484 million for the year ended December 31, 2005. Visudyne sales for the fourth quarter declined by 13% over the same quarter in 2004 and the full year represented an increase of 8% over annual sales in 2004……. Coastal Contacts Inc. (Vancouver) announced that the Corporation has agreed to sell, on a bought deal underwritten basis, 8,000,000 special warrants by way of private placement, at a price of $2.50 per special warrant, for gross proceeds of $20.0 million to a syndicate of underwriters led by Versant Partners Inc., including Orion Securities Inc. and Octagon Capital Corporation. In addition, the syndicate has an option, exercisable until 24 hours prior to the closing date, to acquire up to an additional 1.0 million special warrants for additional gross proceeds of $2.5 million….. Lorus Therapeutics Inc. (Toronto), a biopharmaceutical company specializing in the development and commercialization of pharmaceutical products and technologies for the management of cancer, announced that it has signed a term sheet in respect of a tax assisted financing which, if completed, will raise net cash proceeds of $21.6 million before transaction costs. The tax assisted financing is managed by Biotechnology Management Corporation. The completion of the transaction is subject to a number of conditions precedent, including regulatory and corporate approvals and the completion of legal documentation satisfactory to the parties, and is expected to close on or before February 15, 2006…….. Axcan Pharma Inc. (Mont Saint Hilaire) announced the appointment of Steve Gannon as Senior Vice President and Chief Financial Officer (CFO) in order to enhance its senior financial team. This appointment will be effective April 3, 2006. Mr. Jean Vézina, formerly CFO, will continue to serve in the role of Vice President, Finance…….. CryoCath Technologies Inc. (Montreal) the global leader in cryotherapy products to treat cardiovascular disease, announced that Steve Gannon has resigned his position of CFO effective February 24, 2006…….. Haemacure Corporation (Montreal) announced that it has received payment of US$1 million from Baxter Healthcare S.A., 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…….

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