Life sciences news briefs (August 26, 2003)

Ottawa, ON August 26, 2003 The following life sciences news briefs were published recently by Industry Canada.

1) Pharmaceuticals Update

MDS Nordion secures supply of key cancer-fighting medical isotope

MDS Nordion (Ottawa), a supplier of medical isotopes, announced it is licensing technology to NTP Radioisotopes, a subsidiary of the South African Nuclear Energy (Necsa) that will see NTP become a contract supplier to MDS Nordion of yttrium-90, an important medical isotope used in radioimmunotherapies to treat cancer. NTP has also been licensed to use MDS Nordion’s Y-90 production technology to produce and market Y-90 under its own brand in countries outside of Europe and North America. The company says its Y-90 generators in Fleurus, Belgium, already constitute the largest Y-90 production capacity in the world. This new partnership will create an additional source of supply to MDS Nordion of Y-90 radiochemical for processing into Y-90 radiopharmaceutical used to manufacture cancer drugs such as IDEC Pharmaceuticals’s Zevalin. An approved radioimmunotherapy, Zevalin is used to treat a form of non-Hodgkin’s lymphoma.

Bioniche preliminary results of Cystistat trial announced

Bioniche Life Sciences (Belleville) announced preliminary results of its North American clinical trial of Cystistat (sodium hyaluronate). The double-blind, randomized, placebo-controlled trial evaluated 138 interstitial cystitis patients at 17 clinical sites in Canada and the US. Patients 18 years-of-age or older and diagnosed with interstitial cystitis according to National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) criteria were eligible for the study. The primary endpoint of response as defined by patient global satisfaction and pain reduction at week 8 was satisfactory in the Cystistat cohort (greater than 50%); however the Cystistat response rate was not statistically different from that of placebo. This result appears to be due to a placebo response rate much larger-than-expected. Bioniche is currently completing an analysis of the trial and discussing the significance of the results with principal investigator Dr Kristene Whitmore of the Graduate Hospital in Philadelphia, Pennsylvania, and with the FDA Center for Devices and Radiological Health, and the Health Canada Medical Devices Bureau.

Medicure: receipt of its first patent in the treatment of stroke

Medicure (Winnipeg), a cardiovascular drug discovery and development company, announced that it has been issued patent No 6,586,141, “Treatment of cerebrovascular disease”, by the US Patent and Trademark Office. The newly issued patent, the company’s seventh, protects the use of several of Medicure’s novel therapeutics in the treatment of stroke and related conditions. It marks the company’s first patent issued for stroke.

Lorus and NCI granted FDA approval for a Phase II of GTI-2040

Lorus Therapeutics (Toronto) announced that the US Food and Drug Administration has approved the US National Cancer Institute’s (NCI) Investigational New Drug Application to begin a Phase II clinical trial to investigate Lorus’ lead antisense drug, GTI-2040, as a treatment for metastatic breast cancer in combination with capecitabine (Xeloda, Roche). On February 11, 2003, Lorus announced a formal clinical trial agreement between the NCI and Lorus in which the NCI will financially sponsor a series of Phase II clinical trials to investigate the safety and efficacy of GTI-2040 in six different cancer indications, while Lorus will provide the drug. This clinical trial of GTI-2040 in breast cancer is based on positive results obtained in previous preclinical and clinical investigations with the drug, and is the second clinical trial initiation in collaboration with the NCI to be approved by the FDA. The first was a clinical study with GTI-2040 in combination with cytarabine for the treatment of acute myeloid leukemia. GTI- 2040 is also in a Phase II clinical trial in the U.S. for the treatment of kidney cancer.

AlphaRx ships Flexogan to United Pharmacists

AlphaRx (Richmond Hill) announced that it has shipped Flexogan to United Pharmacists in central Canada. Established in 1978, United Pharmacists operates independent banner programs in Manitoba, northern Ontario, and Alberta, and distributes wholesale products throughout Canada. All six SKUs of Flexogan will be featured chain-wide in over 170 stores under several banners across central Canada.

2) Therapeutics

Resverlogix acquires cell therapy cancer technology

Resverlogix (Calgary), is an Alberta-based research and development company introducing innovative new technologies for upgrading cholesterol reduction and therapeutic cancer research. Resverlogix announced today that it has entered into an agreement to acquire a promising cancer therapeutic from the co-discoverers of the technology, Dr Norman CW Wong and Dr Koichiro Mihara. Dr Wong is a professor of medicine and biochemistry & molecular biology, University of Calgary, faculty of medicine, and is a co-founder and principal shareholder of Resverlogix. Dr Mihara is a research associate, department of biochemistry and molecular biology, faculty of medicine, University of Calgary. Resverlogix is acquiring the new cancer therapy to commence the process of commercialization of the technology.

Hemosol study confirms problems with Hemolink

Hemosol (Toronto) released a preliminary report confirming problems with its lead blood substitute product, Hemolink. The company said its independent safety review committee has completed a review and has produced its preliminary report confirming Hemosol’s observation of a higher incidence of myocardial infarction associated with Hemolink. "While the study included a limited number of patients, there was no apparent difference in mortality or length of hospital stay between the Hemolink group and the control group,” Michael Shannon, vice president of medical affairs at Hemosol, said in a statement.

Standard drug best for preventing clot recurrence

Conventional-intensity therapy with the blood-thinning drug warfarin is more effective and just as safe as low-intensity therapy for the long-term prevention of blood clots in the veins, known as venous thromboembolisms (VTE), according to a report in the August 14 issue of The New England Journal of Medicine. Conventional-intensity therapy is known to be very effective at preventing recurrent VTE. However, such therapy is also tied to a substantial risk of bleeding. In the current study, Dr Clive Kearon, from McMaster University in Hamilton, and colleagues were hoping that switching patients to low-intensity warfarin therapy after a period on standard therapy would decrease the risk of bleeding without compromising the anti-VTE effects. The study involved 738 patients who had experienced one or more episodes of unprovoked VTE. After receiving at least three months of conventional warfarin therapy, the patients were randomized to continue this therapy or to begin low-intensity therapy. The average follow-up period was 2.4 years. Sixteen patients who received low-intensity therapy experienced a recurrent VTE, compared with only six patients in the conventional therapy group. In contrast, a similar number of patients nine in the test group and eight in the conventional group experienced a major bleeding episode.

3) Medical Devices

Genyous: new test to improve chance of surviving lung cancer

Genyous Diagnostics (Vancouver), an integrated cancer solutions company, announced the launch of clinical trials of a new, non-invasive early detection test with the potential to help prevent tens of thousands of deaths from lung cancer every year. Data from this clinical trial will support a submission to Health Canada for approval of the AQC MAC Test as a tool to aid in the detection of early stage cancer.

GE announces agreement with Advanced Research Technologies

GE Medical Systems (Waukesha), a unit of General Electric has reached agreement w
ith ART Advanced Research Technologies (Montreal) under which GE will act as exclusive worldwide distributor for ART’s pre-clinical optical molecular imaging system, SAMI, used in research and development for new therapeutic and diagnostic drugs. ART’s system is an optical fluorescence molecular imaging device developed to help pharmaceutical companies and research laboratories to better understand disease and reduce the development cycle for new drugs. The technology is based on ART’s proprietary time domain optical imaging technology. With the use of specialized laser sources and sensitive detectors, it non-invasively images tissue in-vivo and reveals the biological distribution and concentration of fluorescent-labeled markers, which are introduced into tissue as part of the testing process for new therapeutic and diagnostic drugs. In turn, the molecular imager can help researchers and pharmaceutical companies quickly demonstrate the effectiveness of a potential drug or observe its side effects on organs not targeted by the treatment.

4) Industry Update

ARC Pharmaceuticals (Vancouver) announced that it presented a scientific paper entitled “Camptothecin (CPT) Loaded Films for the Prevention of Surgical Adhesions” at the 6th World Congress on Inflammation held in Vancouver, BC August 2-6th.

AltaRex (Edmonton) announced that it has entered into an agreement with its major strategic partner, United Therapeutics, to expand the territory granted to United under the existing exclusive license agreement to include Germany.

QLT (Vancouver) announced that it has appointed C Boyd Clarke to its board of directors. Clarke is chairman and chief executive officer of Neose Technologies, a publicly traded biopharmaceutical company.

ProMetic Life Sciences (Montreal) and Arriva Pharmaceuticals (Almeda) announced that their joint venture, Arriva-ProMetic, has successfully completed a Phase I clinical trial for its proprietary recombinant Alpha 1-antitrypsin (rAAT) topical gel in patients with atopic dermatitis.

QLT (Vancouver) completed its previously announced offering of US$172.5 million aggregate principal amount of 3.0% convertible notes due 2023 (including the $22.5 million initial purchaser’s option which was fully exercised on August 13, 2003).

Oncolytics Biotech (Calgary) announced that it has entered into a private placement with a European institutional investor and various Canadian investors. Subject to regulatory approval and upon completion of the transaction, Oncolytics will issue 1,363,900 common shares and 681,950 common share purchase warrants for aggregate gross proceeds of approximately $4.1 million.

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).