Life Science News Briefs Vol. 7 no.31 - November 21 2007

• Pharmaceuticals & Biotherapeutics Update
• Clinical Trials Update
• Medical Devices and Diagnostics Update
• Industry Briefs
  

Pharmaceuticals & Biotherapeutics Update

Apotex Acquires Topgen E.S.V. in Belgium from Zambon

Apotex Inc., (Toronto) the largest Canadian-owned generic company announced the purchase from Zambon of the pharmaceutical company, Topgen, E.S.V. of Belgium. No acquisition price was disclosed. Topgen, headquartered in Brussels, is the 7th largest generic pharmaceutical company in this country with approximately 30 generic registrations and has a nation-wide sales force that reaches over 4,000 doctors and 3,000 pharmacies. The Belgian generic market is less developed than many other markets in Europe, with about a 10% marketshare, but it continues to experience strong growth. "This acquisition represents an important milestone for Apotex International as it extends the organization's footprint in Europe and will be a launching pad for many E.U. products currently in the Apotex development pipeline," stated Andrew Kay, Apotex International President. www.apotex.com

Chromos provides update

Chromos Molecular Systems Inc. (Burnaby) provided an update on its on-going restructuring efforts. Chromos announces that it has completed the sale of its ACE System technology to Glaxo Group Limited. A portion of the proceeds from this sale transaction was used to fund the $1.1 million required to be paid under the terms of the creditor proposal announced in the Company's August 28, 2007 press release. The remaining proceeds provide some additional working capital to fund ongoing operations. Since filing for creditor protection in April 2007, the Company has: (a) completed the sale of its ACE System; (b) completed its previously announced sale of CHR-1103 and CHR-1201; (c) satisfied all of its obligations to secured creditors; and (d) satisfied all of the conditions of the court approved proposal to unsecured creditors. Chromos currently has some cash, certain business assets and minimal liabilities. The Company does not believe that its remaining business assets are sufficient to pursue continued operations for the longer term or to support a listing on the TSX. Accordingly, management and the Board of Directors are reviewing Chromos' strategic options and will make further announcements in due course. www.chromos.com

Protox collaborates with BrainLAB for Brain Cancer Program

Protox Therapeutics Inc. (Vancouver) announced that it has entered into a collaborative research and clinical development agreement with BrainLAB AG for use of the BrainLAB proprietar drug delivery software iPlan(R) Flow in the planned pre-pivotal primary brain cancer clinical trial of PRX321. Terms of the final agreement have not been released. As part of the agreement, BrainLAB will supply and install its iPlan Flow software at all clinical sites participating in the pre-pivotal trial. The software will incorporate patient-specific information to monitor and potentially predict drug distribution in and around the brain tumor. Using the iPlan Flow software, neurosurgeons will be able to better plan treatments and optimize catheter placement for ideal delivery and distribution of PRX321. www.protoxtherapeutics.com

Clinical Trials

Aeterna Zentaris Announces Completion of Patient Enrollment

Aeterna Zentaris Inc. (Quebec City), a global biopharmaceutical company focused on endocrine therapy and oncology, announced the completion of patient recruitment for the Company's European multi-center Phase 2 trial in non-small cell lung cancer (NSCLC) with its novel, first-in-class, oral signal transduction inhibitor, perifosine. This randomized, double-blind, placebo-controlled trial will assess the efficacy and safety of a 150 mg daily dose of perifosine when combined with radiotherapy in 160 patients with inoperable Stage III NSCLC. Patients receive perifosine daily for 5 to 6 weeks, starting seven days prior to radiotherapy, and are followed for at least 12 months. The primary endpoint of this trial is the extent and duration of local control, i.e., the absence of tumor recurrence or progression in the area that has been irradiated. The trial is being conducted in collaboration with the Netherlands Cancer Institute. The lead investigator is Marcel Verheij, MD, Ph.D., of the Department of Radiation Oncology / Division of Cellular Biochemistry, at The Netherlands Cancer Institute in Amsterdam. www.aeternazentaris.com

Akela Pharma announces final positive results

Akela Pharma Inc. (Montreal), a drug development company focused on developing therapies for the inhalation and pain markets, announced positive final results from its pilot GHRH Phase II study. Within only 4 weeks of treatment, Akela GHRH induced a highly significant stimulation of endogenous growth hormone (GH) secretion and a marked increase of circulating insulin-like growth factor (IGF-1) as compared to placebo in patients with chronic kidney disease. These endocrine effects were associated with a significant increase in Fat Free Mass (FFM), and concomitant reduction in Fat Mass (FM) when measured by DEXA scan and bioelectrical impedance (BIA). As we reported in July 2007, the study did not reveal significant changes between treatment groups in total body protein turnover. Total body protein turnover, as measured by 13C leucine kinetics, was normal in both treatment groups already at baseline, most probably reflecting adaptative changes of metabolic balance in the chronic disease state. www.akelapharma.com

BioMS Medical achieves enrollment milestone in multiple sclerosis trial

BioMS Medical Corp. (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced that more than 133 patients have been enrolled in its MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). An interim safety and efficacy analysis will be performed on data from the first 133 patients enrolled when they have completed 24 months of the clinical trial. "There has been overwhelming enthusiasm and support from the MS community for our U.S. Phase III trial," said Kevin Giese, President and CEO of BioMS Medical. The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive). www.biomsmedical.com

Thallion Announces Positive Safety and Efficacy Data

Thallion Pharmaceuticals Inc. (Montreal) presented positive safety and efficacy data from the completed Phase I/II trial of ECO-4601 for the treatment of advanced cancer patients. These results support and confirm preliminary results from the dose escalation portion of the study disclosed earlier this year at the annual ASCO meeting. ECO-4601 was safe and well-tolerated up to the maximum dose tested of 480mg/m2/day. Adverse events potentially related to ECO-4601 were nonspecific and common in this type of patient population. Furthermore, in seven refractory cancer patients who had completed six cycles of treatment, six patients achieved stable disease. The Company intends to advance ECO-4601 into a Phase II trial in an indication to be selected over the coming weeks. The Company plans to initiate regulatory filings prior to the end of the fourth quarter in order to commence a Phase II trial. www.thallion.com

Medical Devices and Diagnostics Update

MedMira's HIV Test Approved Under USAID Initiative

MedMira Inc., (Halifax), a global market leader in premium rapid diagnostic solutions, announced that its Reveal G3 Rapid HIV-1 Antibody Test has been approved for purchase by the U.S. Agency for International Development, resulting in the placement of Reveal G3 on USAID's rapid HIV test procurement list. USAID's office of HIV/AIDS is responsible for leading the Agency's efforts within the President's Emergency Plan for AIDS Relief; a $15 billion multifaceted approach to combating HIV and AIDS in over 100 countries, with particular emphasis on fifteen focus countries in Africa, Asia and Latin America. MedMira's inclusion on this procurement list enables Reveal G3 to be purchased for USAID-funded projects, and permits countries receiving USAID funding to purchase Reveal G3 under the PEPFAR program. www.medmira.com

Ceapro Signs Agreement With Gamma-Dynacare Medical Laboratories

Ceapro Inc. (Edmonton) announced its proprietary diabetes test meal, CeaProve® will be distributed through an agreement with Gamma-Dynacare Medical Laboratories, one of the largest and most respected medical laboratories in Canada. CeaProve® is a new and very accessible screening device, complementary to existing tests for diabetes and pre-diabetes. It will be introduced as a pilot program in selected sites in Toronto and Montreal. www.ceapro.com

Covalon Announces New Collagen-Based Wound Dressings

Covalon Technologies Ltd. (Mississauga) announced the launch of BIOSTEPTM and BIOSTEP Ag, the latest products using its proprietary collagen technology for the treatment of chronic wounds. The products were introduced by Covalon's commercial partner Smith & Nephew's Advanced Wound Management division, at the Clinical Symposium in Advanced Wound Care in Nashville, Tennessee, on October 11, 2007. The unique and innovative BIOSTEP products create a moist wound healing environment, deactivate harmful wound proteases and promote tissue growth in chronic wounds, which affect an increasingly large number of patients and have a serious impact on their quality of life. Smith & Nephew Advanced Wound Management has an exclusive worldwide sales, marketing and distribution agreement with Covalon for its advanced range of collagen dressings. The agreement also grants access and distribution rights to an exciting and differentiated new product development portfolio in the field of advanced wound care. www.covalon.com

Industry Briefs

Helix BioPharma Corp. (Aurora) announced position changes for Dr. Donald Segal and John Docherty. Effective immediately, the joint role of Chief Executive Officer and President formerly held by Dr. Segal will be separated whereby Dr. Segal will remain the Company's Chief Executive Officer and Mr. Docherty will assume the role of President. www.helixbiopharma.com

Microbix Biosystems Inc. (Toronto) announced that it has completed a brokered private placement financing totaling $6.825 million, resulting in the issue of 6.5 million units at a price of $1.05 per unit. Each unit comprises one common share of Microbix and one-half of one common share purchase warrant. Each whole warrant entitles the holder to purchase one additional common share of Microbix until November 13, 2012, at $1.26 per share. The financing was led by Dundee Securities Corporation and included J.F. Mackie & Company Ltd. www.microbix.com

Immunotec Inc. (Montreal) announced that it has received regulatory approval from Health Canada to market HMS 90 / IMMUNOCAL with the following health claim: "a natural source of the glutathione precursor cysteine for the maintenance of a strong immune system." The Natural Health Products Directorate (NHPD) is Health Canada's division responsible for the evaluation of the safety, efficacy and quality of natural health products. It has issued a Natural Product Number (NPN) for HMS 90 / IMMUNOCAL based on the credibility, strength and quality of evidence provided to support the claim. www.immunotec.com

Bradmer Pharmaceuticals Inc., (Toronto) a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, announced that Mr. Robert Rieder has resigned as a Director of Bradmer in order to focus on other professional interests. www.bradmerpharma.com

SQI Diagnostics Inc. (Toronto), a medical systems automation company focused on evolving laboratory-based biomarker testing, announced that Peter Winkley has been appointed to its Board of Directors and will join the Company's Audit Committee. www.sqidiagnostics.com

SemBioSys Genetics Inc. (Calgary), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, announced that it has completed its previously announced private placement offering of 3,680,000 units of the Company at a price of $2.60 per Unit for total gross proceeds to the Company of $9,568,000. The offering was completed by a syndicate of underwriters led by Acumen Capital Finance Partners Limited and including PI Financial Corp. The Underwriters purchased 2,500,000 Units on a bought deal basis and exercised their over allotment option in full to place an additional 1,180,000 Units on the same terms. www.sembiosys.com

Stem Cell Therapeutics Corp. (Calgary) announced the appointment of Dr. Francesco Bellini, Chairman, President and CEO of Neurochem Inc., an industry leader in the development of therapeutic drugs for the Central Nervous System, to its Board of Directors. www.stemcellthera.com

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