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Life sciences news briefs from Industry Canada (June 17, 2003)


Ottawa, ON June 17, 2003 The following life sciences news briefs were recently published by Industry Canada.

1) Pharmaceuticals Update

Biomira Phase II colorectal trial results for Theratope vaccine

Biomira (Edmonton) and its collaborator, Merck of Darmstadt, Germany, announced that Biomira’s Phase II study of Theratope vaccine in the treatment of metastatic colorectal cancer showed that patients are capable of mounting an immune response to the investigational vaccine while receiving concurrent chemotherapy. Findings from the Phase II colorectal study showed that patients are capable of mounting an immune response to Theratope even while receiving concurrent chemotherapy. In an exploratory analysis across previous Phase II studies where the vaccine was administered following chemotherapy, the strength of the immune response appeared to correlate with improved survival in a group of patients with different cancers. A preliminary Kaplan-Meier Time to Disease Progression Curve of 16 of the 20 colorectal cancer patients who received combination chemotherapy plus at least four Theratope vaccinations in the featured study showed a current median of 8.4 months for progression of their disease.

OvaRex study demonstrates benefit for ovarian cancer patients

AltaRex (Edmonton) announced results of a phase II trial of OvaRex (oregovamab). The results of this placebo-controlled trial in stage III/IV ovarian cancer patients identified a population that exhibited a strongly favorable outcome. In this group of patients, median time to disease relapse for OvaRex treated patients (n=34) was 24 months, versus 10.8 months for placebo (n=33) treated patients (p=0.06). The clinical outcome favored OvaRex treatment, 13.3 versus 10.3 months in placebo treatment (p=ns), for the primary outcome of time to relapse, as measured by the investigator or independent endpoint monitoring committee. Further analysis of the data revealed a well-defined population that demonstrated a dramatic clinical benefit as compared to placebo. This group is characterized by patients with optimal surgical cyto-reduction, a favorable CA125 response to chemotherapy, and no evidence of disease following chemotherapy. Patients with less favorable outcome and response to surgery and chemotherapy did not appear to benefit from the treatment following front-line chemotherapy. The side effect profile for OvaRex treatment was similar to placebo, unlike most cancer therapeutics, which can have significant toxicity.

AEterna status on Neovastat Phase III trials in kidney and lung cancer

Dr Bernard Escudier, head of the immunotherapy unit at Institut Gustave-Roussy in Paris, France and lead investigator in Europe for AEterna Laboratories (Quebec) Neovastat Phase III trial in renal cell carcinoma gave a status report on the trial. AEterna is currently conducting a double-blind randomized placebo controlled Phase III trial for renal cell carcinoma with its lead antiangiogenic compound, Neovastat, involving 302 patients. Patient recruitment was completed in December 2001 and the trial is still at the patient survival monitoring stage, increased patient survival time being the primary endpoint of the study. Following discussions with the FDA (US), Health Products and Food Branch (Canada) and Medicines Control Agency (UK), analysis of the trial’s database will start when the number of deceased patients has reached 230.

Medicure announces second clinical candidate and Phase II/III program

Medicure (Winnipeg) announced that it is moving forward with a submission for the commencement of the Phase II/III clinical development program for its second product, MC-4232, for use in the treatment of hypertension. In a pre-IND meeting to consider Medicure’s proposed development of MC-4232, the US Food and Drug Administration agreed in principle with Medicure’s plan with regard to the proposed Phase II/III clinical program. Based on the plan presented to the FDA, Medicure expects to commence the initial study in the third quarter of calendar 2003. This second clinical candidate follows the successful results from a recently completed Phase II clinical trial, which showed that the company’s lead product, MC-1, reduces ischemic heart damage following angioplasty. The results demonstrated the cardioprotective effects and safety of MC-1 in high-risk patients undergoing angioplasty. Ischemia and ischemic reperfusion injury remain a major inadequately treated area of cardiovascular medicine.

Isotechnika releases final results of Phase IIa kidney transplant trial

Isotechnika (Edmonton) announced that the company presented the final results of its Phase IIa kidney transplant study at the American Transplant Congress in Washington, DC. Designed to evaluate ISA247, Isotechnika’s lead immunosuppressive drug, in stable kidney transplant patients, the study showed positive results and demonstrated that ISA247 was well tolerated and efficacious. All of the primary and secondary endpoints of the study were achieved. The primary endpoint of the trial was to demonstrate that stable kidney transplant patients on ISA247 experienced no change in kidney function when compared to patients in the cyclosporine (Neoral formulation) arm of the study. One of the secondary endpoints of the study was to monitor safety parameters in kidney transplant patients receiving ISA247; one of which was to measure the incidence of graft rejection. The final secondary endpoint of the study was to measure the pharmacodynamics and pharmacokinetics of ISA247 in kidney transplant patients. The data showed that all of these endpoints were met.

2) Diagnostics and Therapeutics Update

Health Canada recommends Plan B for non-prescription status

Paladin Labs (Montreal) announced that Health Canada is recommending the switch from prescription to non-prescription status for Plan B, the company’s emergency contraceptive pill. Health Canada will now solicit feedback from stakeholders and initiate the process required to change the regulations that will allow Plan B to be sold without a prescription. Currently, Plan B is available by prescription only. Authorities in Quebec, British Columbia and Saskatchewan, have given pharmacists “prescriptive authority”, allowing them to dispense Plan B without a physician’s prescription.

Spectral completes Canadian distribution agreement with Medtox

Spectral Diagnostics (Toronto) announced the completion of an exclusive distribution agreement with Medtox Scientific, Spectral will be the exclusive distributor in Canada for Medtox’s rapid Drugs of Abuse diagnostic products to the clinical marketplace, including the Verdict-II and Profile-II ER product line. Based in St. Paul, Minnesota, Medtox is a leading developer and manufacturer of rapid point-of-collection products for drugs of abuse, therapeutic drugs, biological and agricultural toxins.

Axcan to develop Photofrin PDT for the treatment of Cholangiocarcinoma

Axcan Pharma (Mont St Hilaire) announced that it will support Phase II studies on the use of Photofrin photodynamic therapy in the treatment of cholangiocarcinoma, a malignant (cancerous) growth in the ducts that carries bile from the liver to the small intestine. “Preclinical studies on human cholangiocarcinoma cell line models, as well as small clinical pilot studies, have indicated that Photofrin PDT can induce significant tumor reduction and growth rate delay, commented Dr Patrick Colin, vice president, clinical research of the company. “These encouraging findings led to a more rigorous research program on the use of PDT Photofrin in the palliative treatment of advanced cholangiocarcinomas. Although the use of Photofrin for cholangiocarcinoma is a relatively limited market, providing patients with symptom relief and extending their survival is very important. It once more demonstrates that Photofrin PDT can be used successfully to treat various cancers related to the gastrointestinal tract,” he concluded.

Vasogen issued US patent in chronic heart fa
ilure

Vasogen (Mississauga) announced that the US Patent and Trademark Office has issued patent No 6,572,895 covering the use of Vasogen’s immune modulation therapy in the treatment of chronic heart failure. Chronic heart failure affects more than five million people in North America, and is the only major cardiovascular condition that is still increasing in incidence and prevalence.

McGill researchers prove tropical oil blend beneficial to weight loss

A new cooking oil designed by McGill researchers may soon offer relief to calorie counters and cholesterol watchers. Peter Jones, a professor at McGill’s School of Dietetics and Human Nutrition in Montreal (Canada), has completed two promising studies on a new blend of cooking oil that enables people to heighten their metabolism, lower their cholesterol and, in some cases, lose weight. How the functional oil works in fighting fat is simple. “It is directed towards the liver for combustion and burned as energy,” says Jones. “The oil is not stored in the body as fat and heightens the metabolism, which is a key in maintaining a healthy body weight. There is also some provocative data suggesting that oils rich in MCT reduce appetite.” By combusting, rather than absorbing the functional oil, male participants lost an average of one pound over a month. “After consuming the functional oil over a year, a man could lose one pound per month or 12 pounds per year,” says Jones, noting that while female participants experienced heightened metabolic rates, they did not experience any measurable reduction in body fat.

3) Industry Update

Angiotech Pharmaceuticals (Vancouver) was notified by its corporate partner, Boston Scientific, that the requirements for payment of its sales milestone license fee to Angiotech was satisfied in the first quarter of 2003. Under the terms of the contract, Angiotech received a payment consisting of the sales milestone license fee of approximately US$4.3 million dollars. It is Boston Scientific’s final milestone payment to Angiotech under the license agreement.

PanGeo Pharma (Montreal) announced that Sean Cleary has resigned as president and director of the company, effective immediately. Cleary joined the company in January 1999 and was largely responsible for the company’s growth in Canada, from $3 million in sales to over $60 million.

Fytokem Products (Saskatoon) announced that Greg Dutka, vice-president – marketing & corporate development will resign his position effective July 11, 2003. Greg has accepted a position with a local nutraceutical company.

Bioniche Life Sciences (Belleville) has been recognized as an exclusive member of Profit 100, the 15th annual ranking of Canada’s fastest-growing companies by Profit: Your Guide to Business Success.

Lorus Therapeutics (Toronto) announced that it has filed a final prospectus in each of the provinces of Canada in connection with its previously announced best efforts offering of units at a purchase price of $1.25 per unit. Each unit consists of one common share and one-half of one common share purchase warrant. Each whole warrant will entitle the holder to purchase a common share at a price of $1.75.

MIV Therapeutics (Vancouver) announced the company’s listing application has met all admission requirements and has been accepted for listing on the Berlin Stock Exchange. MIV Therapeutics will trade under the ticker symbol MIV.BE and German Securities Cusip number WKN 798618. The listing will be effective the second week of June 2003. MIVT will continue to trade on the Nasdaq OTC Bulletin Board.

Patheon (Toronto) announced that its Italian subsidiary has entered into a new manufacturing services agreement with Roche to continue to supply Roche with solid, liquid and sterile products for the European market.

IsoTis (Lausanne) unveiled a definitive merger agreement to acquire GenSci Regeneration Sciences, a Toronto-based orthobiologics firm emerging from Chapter 11 bankruptcy.

Redasoft (Toronto) announced that Digital Data Management will provide the exclusive distribution of Redasoft’s Visual Cloning 3 software to Japanese life science researchers.

Contract Pharmaceuticals Limited Canada (Mississauga), a contract manufacturing organization in Mississauga, acquired Innopharm, a contract services laboratory in Markham. Both organizations support the pharmaceutical and biotechnology industries.

MDS Sciex (Toronto) and Eksigent Technologies, a leader in the growing field of microfluidics announced that MDS Sciex will co- market and distribute Eksigent’s NanoLC system on a global basis. The NanoLC system is the first HPLC (High Performance Liquid Chromatography) system to allow nanoscale LC/MS (liquid chromatography-mass spectrometry) without flow splitting.

Generex Biotechnology (Toronto) announced an agreement in principle to acquire all of the shares of privately owned Antigen Express, in exchange for a maximum of 2,850,000 shares of the company’s common stock.

Life Sciences News Brief is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Paul Vaillancourt; Telephone: (613) 952-7700; E-mail: vaillancourt.paul@ic.gc.ca).