Life sciences briefs from Industry Canada (March 24, 2003)

Ottawa, ON March 24, 2003 The following life sciences news briefs were recently published by the Life Sciences Branch of Industry Canada.

1) PHARMACEUTICALS UPDATE

Lorus Therapeutics Allowed US Patent for Key Antisense Anticancer Target

Lorus Therapeutics Inc (Toronto) announced that the United States Patent and Trademark Office has allowed a patent to protect the company’s intellectual property involving a lead anticancer target, the R1 component of ribonucleotide reductase. This patent broadens the protection that Lorus obtained in a patent granted by the United States Patent and Trademark Office in September 2000. Ribonucleotide reductase is an essential part of the process that converts ribonucleotides to deoxyribonucleotides, which are required for DNA replication and cell proliferation. Inhibition of ribonucleotide reductase by antisense drugs would lead to depletion of the supply of deoxyribonucleotides to tumor cells, and dramatic reduction in tumor growth. GTI-2040 and GTI-2501 are antisense drugs directed at the R2 and R1 subunits of ribonucleotide reductase, respectively.

Cardiome Commences Phase II/III Study in Heart Failure

Cardiome Pharma Corp. (Vancouver) reported that it has commenced patient dosing of oxypurinol in a phase II/III study of patients with congestive heart failure. Congestive heart failure (CHF) is the failure of the heart to pump adequate amounts of blood to meet the needs of the body. The condition is life threatening and produces symptoms of fatigue, shortness of breath and swelling from fluid retention. Oxypurinol belongs to a class of drugs that have been shown to increase cardiac efficiency by increasing the pumping action of the heart without a proportionate increase in oxygen consumption by the heart. In the 400 patient randomised placebo controlled trial, patients will receive oral oxypurinol or placebo for a period of six months. The oxypurinol will be administered in addition to standard medications, which may include diuretics, digitalis, ACE inhibitors and beta-blockers. The objective of the study is to define the efficacy of oxypurinol using surrogate measures of clinical efficacy (six-minute walk test, maximum oxygen consumption, and quality of life), as well as clinical outcomes (eg, death, worsening heart failure, and hospitalization).

MHI Study Finds Drug Enalapril Reduces Incidence of Diabetes

In a study conducted by the Montreal Heart Institute (MHI), enalapril, a drug used to treat hypertension and heart failure, substantially reduced the incidence of new cases of diabetes in patients suffering from heart disease. The beneficial effect was even more important in patients with abnormal fasting plasma glucose levels at the beginning of the study. Follow-up visits were scheduled two and six weeks after the beginning of the study and every four months until the end of the study, for a mean follow-up of three years. Fasting plasma glucose levels were measured at almost every visit (mean of eight samples per patient) during the study follow-up. During follow-up, 22.4% of patients in the placebo group developed diabetes compared with only 5.9% of patients in the enalapril group. The effect of enalapril was even more striking in the subgroup of patients with abnormal fasting plasma glucose levels at baseline: diabetes appeared in only 3.9% of patients treated with enalapril compared with 48% in the placebo group.

2) DIAGNOSTICS AND THERAPEUTICS UPDATE

Biophage Pharma Announces Two New Discoveries

Biophage Pharma Inc (Montreal), a Canadian biopharmaceutical company engaged in the development of new therapeutics in two core domains: the treatment of antibiotic-resistant infections in livestock and inflammatory diseases in humans, reported two important discoveries by Professor Ghislain Opdenakker, member of the Scientific Advisory Board of Biophage. These new data demonstrate that Interferon-beta (IFN-beta) and insulin are readily degraded by the matrix metalloproteinase 9 (MMP-9), the target enzyme for Biophage’s proprietary REGA-3G12 antibody. This MMP-9-induced degradation leads to a decrease of the biological effect of these proteins. Clinically, these findings may have several important implications as recombinant IFN-beta is currently used for treatment of multiple sclerosis while insulin is used for the treatment of diabetes. The worldwide annual market for insulin and IFN-beta is estimated to be in the USD 2-4 billion ranges, respectively.

IIsotechnika’s Phase II Clinical Trial of ISA247 in Patients With Psoriasis

Isotechnika Inc (Edmonton) announced that the final data obtained from its Phase II study to evaluate its novel immunosuppressive therapy, ISA247, in patients with moderate to severe psoriasis showed positive results and demonstrated that ISA247 is well tolerated and efficacious. The trial results convincingly showed that ISA247 met or exceeded all of the primary and secondary efficacy and safety endpoints of the study. In the high dose arm of the study, the data showed that 74% of the patients achieved this parameter (p < 0.0001) as compared to 18% for the low dose group and 0% in the placebo group. Further, a 50% reduction in PASI scores was observed in 88% of the patients in the high dose group and 40% of the patients in the low dose patient group. These efficacy results were achieved without any significant adverse effect on blood pressure and lipid levels. The mean serum creatinine levels remained within the acceptable reference range indicating normal kidney function was maintained for all dosing groups. No significant adverse events (SAE) were recorded in the trial, which provided further confirmation of drug safety and tolerability.

URRMA Biopharma Initiates Last Study Prior to Filing

URRMA Biopharma Inc (Montreal) announced that it has initiated its last study prior to the filing of a Premarket Approval (PMA) dossier with the US Food and Drug Administration (FDA) for the US commercialization of its Anti-R7V Diagnostic Kit. The study represents the last of six studies, involving a total of 1450 patients, requested by the FDA. URRMA is also very proud to announce that the prestigious MACS (Multi-Center AIDS Cohort Study) has agreed to actively participate in this last study. MACS is the most respected and recognized study of this kind in the USA. This Multi-center AIDS Cohort monitors 5,622 male seropositive patients in the US and was started in 1983. It is funded by the US National Institute of Allergy and Infectious Diseases (NIAID), the US National Institute of Health (NIH), and the US National Cancer Institute (NCI). The centers involved with MACS include Johns Hopkins’ Hospital in Baltimore, Northwestern University in Chicago, University of California in Los Angeles, and University of Pittsburgh.

Cangene Enters into Agreement for its Vaccinia Immune Globulin

Cangene Corporation (Toronto) announced that it has concluded an agreement with Acambis plc to market Cangene’s vaccinia immune globulin (VIG) product in markets outside of North America and Israel. Cangene and Acambis will work together to supply this important product. Cangene is currently supplying VIG under contract to the United States Centers for Disease Control and Prevention (CDC). VIG is used in treating and preventing most severe reactions that may be brought on by the administration of the smallpox vaccine. VIG is an antibody product manufactured from human plasma collected from individuals who have been vaccinated with a smallpox vaccine. Cangene is conducting clinical trials in order to apply for US Food and Drug Administration licensure of the product.

3) GENOMICS UPDATE

SignalGene to Cease Operations, Sell Assets

SignalGene Inc (Montreal) announced that the Board of Directors has approved a plan under which the company will cease all of its operations, sell its assets and seek to optimize return to shareholders. Under the plan, SignalGene will endeavour to sell assets, including its proprietary computer-aided drug design technol
ogy, its angiogenesis inhibitors drug discovery program, as well as other tangible assets. As part of the plan, the company will eliminate 31 positions at its head office in Montreal and at the drug discovery unit in Guelph, Ontario. The majority of the departures were effective on March 12, 2003.

4) TECHNOLOGY UPDATE

ID Biomedical Develops Vaccine Manufacturing Technology

ID Biomedical (Vancouver) announced that it has developed a proprietary and scaleable method to manufacture protein antigens, the active ingredients of the company’s subunit vaccines. The recombinant protein cloning and expression system, referred to as ID-CX5, has been used to efficiently produce large quantities of highly purified proteins. Demonstrations of high-level yield and consistency in production have enabled ID Biomedical to transfer the technology to the Good Manufacturing Practices (GMP) production of the protein antigens that comprise the subunit StreptAvax(TM) vaccine. Proteins produced from this platform have been integrated into the company’s current Phase II Clinical Trial of the StreptAvax vaccine. The company has tested the ID-CX5 platform technology in the high yield production of several different recombinant proteins, including the pilot manufacture of a recombinant Plague antigen. Results from these studies proved to be a key competitive advantage in the company’s successful bid to become the GMP supplier of the subunit antigen component of a Plague vaccine being developed by Dynport Vaccine Corporation. ID Biomedical has filed US and international patent applications to protect the technology.

5) INDUSTRY BRIEFS

World Heart Corporation (Ottawa) applauded the favorable vote by the Medicare Coverage Advisory Committee (MCAC) in support of criteria that could expand the current reimbursement of left ventricular assist devices (LVAD) by the US Centers for Medicare & Medicaid Services (CMS) to include implants in end- stage heart failure patients who are not candidates for cardiac transplantation (Destination Therapy).

Anthony Giovinazzo, President of GB Therapeutics Ltd. (Mississauga) announced the appointment of Dr. Mark de Somer as full-time Executive Vice President – R&D of GB Therapeutics.

Tm Bioscience Corporation (Toronto) announced the appointment of Dr. Bradley W. Popovich to Chair of the company’s Scientific Advisory Board (SAB), effective immediately. Dr. Popovich will also join the company’s Board of Directors. In addition, Tm Bioscience announced the appointment of Dr. David E. C. Cole to the Scientific Advisory Board.

Predictive medicine company IMI International Medical Innovations Inc (Toronto) announced that it has received clearance from the US Securities and Exchange Commission (SEC) to become a registered issuer in the U.S., clearing the way for IMI shares to trade on a US stock exchange.

Bioxel Pharma (Quebec), a leading manufacturer of naturally derived taxanes and targeted oncology drugs, announced that the company has signed a long-term supply agreement with Atlantis BioActives Corporation, of Charlottetown, Prince Edward Island for the large-scale production of intermediate taxanes extracted from Bioxel’s Canada yew biomass.

Cangene Corporation (Toronto) announced that it has entered a European marketing and distribution agreement for its WinRho(R) SDF with Baxter Healthcare Corporation. Baxter will market and distribute the product in Europe, excluding Portugal, for treating a blood clotting disorder called immune thrombocytopenic purpura (ITP). It intends to launch in the United Kingdom in the near term.

Hemosol Inc (Toronto) announced that at the recommendation of the company’s Data Safety Monitoring Board (DSMB) it has elected to review safety data prior to continuing enrolment in its cardiac trial (HLK 213/304). This trial involves the use of HEMOLINK(TM) (hemoglobin raffimer) in patients undergoing cardiac bypass grafting (CABG) surgery.

Halifax-based biotechnology company MedMira Inc entered into an agreement at Province House with Health Minister Dr. Leonard Mashako Mamba of the Democratic Republic of the Congo for the purchase of its rapid diagnostic products.