Pharmaceuticals & Biotherapeutics Update

IntelliPharmaCeutics Announces Equity Investment by Par Pharmaceutical

IntelliPharmaCeutics Ltd. (Toronto) announced that Par Pharmaceutical has made a significant equity investment in the Company. IntelliPharmaCeutics Ltd., through its operating company, IntelliPharmaCeutics Corp., develops, licenses and markets both new and generic controlled-release pharmaceutical products. Par Pharmaceutical is amajor developer and distributor of generic and branded drugs in the U.S. market. Under the terms of the investment, Par Pharmaceutical will acquire a 4.2% equity interest in IntelliPharmaCeutics, on terms typical for an investment of this sort and magnitude. The funds will be used by IntelliPharmaCeutics Corp. for general corporate and working capital purposes. http://www.intellipharmaceutics.com

ARIUS announces allowance of US patent for lead anti-cancer antibody

ARIUS Research Inc., (Toronto), a biotechnology company discovering and developing the next wave of antibody therapeutics, announced that the Company has received notice from the United States Patent and Trademark Office that a key patent for its lead anti-CD44 drug candidate will issue on August 7th, 2007, as US Patent Number 7,252,821. This pivotal patent covers the ARH460-16-2 antibody itself, as well as the use of the antibody in the treatment of breast cancers. ARIUS now has 16 issued and allowed patents covering its antibody programs and discovery platform and over 150 patents pending. The ARH460-16-2 antibody drug is in development by ARIUS for breast, prostate and liver cancers. The CD44 antigen that is targeted by this antibody has been identified as a cancer stem cell marker in several different malignancies. The discovery of cancer stem cells and the markers that distinguish this population of cancer cells from others represent a key advancement in the understanding of cancer. Such insights can be used to develop drugs, such as ARH460-16-2, to prevent the spread of cancer and extend survival in cancer patients. Recently ARIUS has also announced the initiation of a toxicology program in preparation for human clinical trials. http://www.ariusresearch.com

Neurochem granted Fast Track designation from U.S. FDA

Neurochem Inc. (Laval) announces that the U.S. Food and Drug Administration (FDA) has designated the investigational product candidate, tramiprosate (ALZHEMED(TM)), as a Fast Track Product for the treatment of Alzheimer's disease. Under the FDA Modernization Act of 1997, the Fast Track designation program is intended to facilitate the development and expedite review of drugs developed for the treatment of serious or life-threatening conditions and that demonstrate the potential to address an unmet medical need for such a condition. http://www.neurochem.com

Clinical Trials

FDA allows long term use of ISA247 in Isotechnika Phase 2b trial

Isotechnika (Edmonton) announced that the Company has received permission from the Food and Drug Administration of the United States (FDA) for the long term use of ISA247 in patients currently participating in the Company's Phase 2b kidney transplant (PROMISE) trial. The Company previously announced in June that it had also received a No Objection Letter from Health Canada for the long term use of ISA247 in this trial. Patients involved in the PROMISE trial are allowed to remain on ISA247 through to commercialization of the drug and beyond after completion of the 12 month trial. Patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored on an ongoing basis. http://www.isotechnika.com

EMEA recommends orphan designation for ISA247 for treatment of uveitis

Isotechnika Inc. (Edmonton) announced that the European Agency for the Evaluation of Medicinal Products (EMEA) committee for Orphan Medicinal Products has adopted a positive opinion on orphan medicinal product designation for ISA247 for the treatment of chronic, non-infectious uveitis. The EMEA will now forward the opinion to the European Commission. The Decision will be adopted by the Commission within 30 days of its receipt. Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, fee reductions and free Scientific Advice. Isotechnika's partner, Lux Biosciences, began enrolling patients in pivotal clinical trials for ISA247 earlier this year. The company is conducting three controlled, double-masked studies aimed at supporting the approval of that product as a treatment for uveitis, collectively designated the LUMINATE program. The LUMINATE program represents the largest and most comprehensive clinical program ever undertaken in the field of uveitis. http://www.isotechnika.com

OncoGenex Initiates Phase I Clinical Trial of OGX-427 in Cancer

OncoGenex Technologies Inc. (Vancouver) announced enrollment of the first patient in an open label, dose-escalation, multi-center Phase I clinical study evaluating a new investigational drug, OGX-427, in patients with breast, ovarian, bladder, prostate or lung cancer. OGX-427 blocks production of Heat Shock Protein 27 (Hsp27), a cell-survival protein that inhibits apoptotic cell death through multiple pathways. The study, which will enroll up to 54 patients with cancers known to overexpress Hsp27, will evaluate the safety, pharmacokinetics and biological activity of OGX-427 alone and in combination with docetaxel. All patients who enter the trial have failed therapies that are potentially curative or failed/refused other standard therapy. Clinical sites in Canada and the United States will participate in the study. Dr. Kim N. Chi, Medical Oncologist at the BC Cancer Agency, is the study's principal investigator. Preclinical studies at the Prostate Centre at Vancouver General Hospital show that OGX-427 significantly decreases levels of Hsp27, induces apoptosis in several human cancer cell lines, has single agent anti-tumor activity, and acts as a chemosensitizer with several cytotoxic drugs, including docetaxel. http://www.oncogenex.com

YM BioSciences Initiates Patient Enrolment In Phase II Cancer Trial

YM BioSciences Inc. (Mississauga), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that it has enrolled the first five patients within the 50-patient initial cohort of its Phase II trial with nimotuzumab in combination with irinotecan for the treatment of patients with colorectal cancer who have previously failed irinotecan-containing regimens. Recruitment of the first cohort is expected to be completed within approximately eight months, following which data on the primary endpoints, response rate and safety, will be reported. The single-arm trial will enroll approximately 100 patients in Canada. The trial will enroll two 50-patient cohorts consecutively, with the first cohort receiving irinotecan on one of the conventional dosing schedules with weekly dosing of nimotuzumab and the second cohort receiving irinotecan on one of the conventional dosing schedules with nimotuzumab every two weeks. The first patient was enrolled into the study at the Southlake Regional Health Centre in Ontario under the principal investigator Dr. Labib Zibdawi. The study principal investigator is Dr. Amil Shah at the BC Cancer Agency in Vancouver. Fourteen sites across Canada are expected to participate in the trial of which two sites are currently open. http;//www.ymbiosciences.com

OncoGenex and Isis Report Encouraging Interim Phase II Data

OncoGenex Technologies Inc. Vancouver) and Isis Pharmaceuticals, Inc. (Carlsbad, CA) announced encouraging preliminary data from an ongoing Phase II clinical trial of OGX-011 in combination with second-line chemotherapy in patients with metastatic hormonerefractory prostate cancer (HRPC). All patients had progressive disease on or within six months of first-line docetaxel therapy. Patients receiving the combination of OGX-011 and re-treatment with docetaxel in the second-line setting are achieving longer survival, longer progression-free survival and more frequent prostate-specific antigen (PSA) decreases than patients treated with OGX-011 in combination with mitoxantrone, a standard second-line chemotherapeutic agent. These data provide additional support for the activity of OGX-011 in combination with docetaxel; previously announced results from another trial reported that OGX-011 plus docetaxel as first-line treatment of HRPC extended the duration of progression-free survival and decreased the rate of disease progression. Based on the results of these and other studies, OncoGenex plans to initiate a pivotal Phase III clinical trial evaluating OGX-011 in combination with docetaxel for the treatment of HRPC. http://www.oncogenex.com

BioMS Medical's relapsing-remitting multiple sclerosis trial

BioMS Medical Corp. (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol. This was the first of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial. The MINDSET-01 phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The fifteen month trial is fully enrolled with approximately 215 patients at 24 sites in 6 countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression. http://www.biomsmedical.com

Akela Pharma Inc. completes patient enrollment in phase IIb trial

AKELA Pharma Inc., (Montreal), a drug development company focused on developing therapies for the inhalation, pain and CNS markets, today announced that it has completed enrolling patients in its Fentanyl TAIFUN(R) Phase IIb trial. Fentanyl TAIFUN(R) is a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform. Phase IIb for Fentanyl TAIFUN(R) is a multi-centered, multinational clinical trial in cancer patients with severe persistent pain on maintenance opioid therapy. The first part of the trial is a single arm, open-label dose titration to evaluate the effective individual dose for significant pain relief with Fentanyl TAIFUN(R) in the treatment of breakthrough cancer pain. The second part includes 28 responders from the open-label arm randomized to receive the titrated doses or placebo. The safety and efficacy data from this double-blind, placebo-controlled extension arm is expected to be available by early September 2007. http;//www.akelapharma.com

Industry Briefs

Angiotech Pharmaceuticals, Inc. (Vancouver), a global specialty pharmaceutical and medical device company, announced that Laura Brege has been appointed to its Board of Directors. http://www.angiotech.com

Ceapro Inc. (Edmonton) has received Notice of Allowance from the Canadian Trademarks Office for its proprietary diabetes testing wafer meal, CeaProve(R). http://www.ceapro.com

 MIGENIX Inc. (Vancouver), a clinical-stage developer of drugs for infectious diseases, reports that the Company's North American and European development and commercialization partner for Omigard(TM), Cadence Pharmaceuticals, has reached agreement with the U.S. Food and Drug Administration (FDA) to increase the number of patients to be enrolled in the ongoing Phase III clinical trial from 1,250 to 1,850. http://www.migenix.com

Aspreva Pharmaceuticals Corporation (Victoria) announced a reorganization of the company's operations in order to better focus on core activities that are expected to drive long-term growth. To achieve this goal, the company expects to reduce staffing levels by approximately 25 percent, or 33 positions worldwide. As part of the restructuring, Dr. Richard Jones, Chief Scientific Officer, will be leaving the company. His responsibilities will be assumed by Dr. Usman Azam, Aspreva's Chief Medical Officer. http://www.aspreva.com

DRAXIMAGE, (Montreal) the radiopharmaceutical division of DRAXIS Health Inc. has taken another significant step in its product development strategy with the filing of its DRAXIMAGE(R) Sestamibi with European regulatory authorities. DRAXIMAGE(R) Sestamibi is a generic kit for the preparation of Tc-99m Sestamibi for injection, which is an imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart and is the largest radiopharmaceutical product in the nuclear medicine market segment. http://www.draxis.com

(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).