Life sciences news briefs (December 12, 2003)

Ottawa, ON — The following life sciences news briefs were published this week by Industry Canada:

1) Pharmaceuticals Update

Lorus Therapeutics publishes preclincal results of NC 381

Scientists at Lorus Therapeutics (Toronto) have published the results of investigations aimed at characterizing a clotrimazole (CLT) analogue, NC 381. CLT is an anti-fungal drug that has demonstrated anti-cancer activity but its potential is limited by the presence of high liver toxicity. The goal of the study was to develop a variation or analogue of CLT that maintained the anti-cancer activity without the toxic side effects. The results appear in an article entitled, “NC 381, A Novel Anti-cancer Agent, Arrests the Cell Cycle in G0-G1 and Inhibits Lung Tumor Cell Growth In Vitro and In Vivo” in a November electronic version of the Journal of Pharmacology and Experimental Therapeutics. The article will also be published in print in an upcoming issue of the journal. The article explained that when a chemical component of CLT responsible for toxicity was removed in designing the analogue NC 381, the new drug inhibited the growth of cancer cells in vitro by a mechanism of action that was similar to CLT. Therefore, this new drug appears to be a safer agent that maintains anti-cancer activity.

Isotechnika: a third drug candidate to its immunosuppressive pipeline

Isotechnika (Edmonton) announced the addition of a third drug candidate to its immunosuppressive drug pipeline. The new drug candidate, TKB662, is designed to address the two major challenges in the field of transplantation, namely chronic rejection and side effects resulting from steroid use. Pre-clinical studies of TKB662 have demonstrated inhibition of T cell and B cell activation and proliferation through multiple mechanisms of action including the inhibition of lymphocyte phosphorylation activity. “Our team’s focused approach allows us to continue expanding our drug pipeline,” stated Dr Randall Yatscoff, Isotechnika’s president and COO. “The multiple sites of action of TKB662 have the potential to reduce the steroid-associated side effects to which the majority of transplant patients are now subjected. TKB662 is complementary to our growing immunosuppressive pipeline, which also includes ISA247 and TAFA93. It is our plan to advance all these compounds through clinical development in an expeditious and cost effective manner.”

Inex submits CMC section of NDA for Onco TCS to the FDA

Inex Pharmaceuticals (Vancouver) announced that it has submitted the chemistry, manufacturing and controls (CMC) section as the second of three major sections in its “rolling submission” of a new drug application (NDA) to the United States Food and Drug Administration (FDA). The NDA is being submitted for marketing approval for Inex’s lead product, Onco TCS, for the treatment of relapsed aggressive non-Hodgkin’s lymphoma (NHL). David Main, president and CEO of Inex, said the CMC section contains data on manufacturing process, stability of the drug, composition of the drug and other chemistry and related information. The first section was submitted September 30, 2003 and included nonclinical safety and pharmacology data. Main said the NDA filing will be completed during the first quarter of 2004 with the submission of the clinical section of the NDA.

2) Diagnostics and Therapeutics Update

Poison from lethal fish could be a painkiller

A tiny Canadian company wants to use poison from a fish — a substance more toxic than cyanide — to help cancer patients suppress pain or to wean heroin addicts off their habit. International Wex Technologies, a Vancouver-based company listed on the small-cap Canadian Venture Exchange, says early trials show positive results from tetrodotoxin, although bigger and more extensive tests will be needed before the product reaches the marketing stage. It says the new drug could be on the market within three years, if all the tests work out. The new drug is derived from a blowfish poison — a substance so dangerous that a mere trace can paralyze a person within minutes. The blowfish is known to gourmets as the source of the sometimes deadly Japanese fugu delicacy, a dish that can be prepared only by trained and licensed chefs, because the slip of a knife can poison the food, causing the diner to drop to the ground convulsing and gasping for air. But the drug derived from the poison, tetrodotoxin, has already passed two phases of clinical tests, and doctors conducting early surveys say it eased pain in terminally ill cancer patients, where no other pain medication had worked.

Axcan submits Salofalk 750 MG tablets for approval in Canada

Axcan Pharma (Mont Saint Hilaire) announced that it has submitted to the Therapeutic Products Directorate of Health Canada a supplemental new drug application for Salofalk in a 750 mg tablet dosage form for the treatment of ulcerative colitis. If approved, this new dosage form will complement the 250 and 500 mg Salofalk tablets Axcan currently markets in Canada for the treatment of inflammatory bowel diseases (Crohn’s Disease and ulcerative colitis).

ChondroGene and the Canadian Arthritis Network enter collaboration

Dr K. Wayne Marshall, president and CEO of ChondroGene Limited (Toronto) and Mr Chris Nelson, President of the Canadian Arthritis Network (CAN), announced that the two organizations have entered into a new research collaboration in which ChondroGene will make its proprietary technology and tools available to CAN researchers and will gain access to CAN’s research activities across Canada. The Canadian Arthritis Network, a member of the federal Networks of Centres of Excellence, is the single point of contact that links 125 leading Canadian arthritis researchers and clinicians, 40 Canadian academic institutions, The Arthritis Society, pharmaceutical and biotechnology companies, and government. Under the collaboration, ChondroGene will make its proprietary technology and tools available to CAN researchers while ChondroGene will have access to CAN research activities at academic institutions across Canada. Specific projects will be identified and undertaken to further advance ChondroGene’s research and clinical objectives with the ultimate goal of developing new diagnostic tools for osteoarthritis, and eventually new therapeutics to treat the disease, not merely the symptoms of the disease.

Stressgen and Roche broaden heat shock protein agreement

Stressgen Biotechnologies (Victoria) and Roche announced an innovative restructuring of their heat shock protein fusion alliance. Under the new agreement, the partnership divides the human papillomavirus (HPV) program for HspE7 into two separate and distinct programs. By separating the development programs, the market potential of HspE7 is optimized, while the strength and resources of both companies are utilized for the mutual benefit of the partnership. This new agreement creates significant value for Stressgen through increased revenues and downstream product rights.

3) Medical Devices

Cedara’s technology partnership program

Cedara Software (Toronto) a leading independent developer of medical software technologies for the global healthcare market, today announced it is launching a new technology partnership program. The program is intended to help commercialize new medical technologies developed by: hospitals, research institutions, medical universities, startup companies, doctors, inventors and others. Cedara will support and assist technology partners by providing access to its research laboratory, marketing department and global sales channel.

4) Genomic Update

TM Bioscience secures $7.3 million investment for new genetic testing

Tm Bioscience (Toronto) announced that its $25 million research and development project to develop several genetic tests will be supported by a $7.3 million investment from Technology Partnerships Canada (TPC), a special operating agency of Industry Canada. These new genetic tests will dramatical
ly improve health care efficiency by allowing Canadian researchers to explore the linkages between disease, genetic mutations and treatment. The project includes the construction of a pilot-scale manufacturing facility and development of a minimum of five genetic tests to regulatory standards. The project completion date is targeted for 2006. Tm Bioscience has agreed to pay TPC a royalty on its revenue and, subject to regulatory approval, will issue TPC $2.5 million worth of five-year common share purchase warrants on December 31, 2005 with an exercise price equal to the current value of the commons shares at that date.

5) Industry Update

World Heart (Ottawa) has now completed its required filings in order to effect the share consolidation that was approved at its special meeting of shareholders on Tuesday, November 25, 2003. Under the share consolidation each seven pre-consolidation common shares will become one new common share. A letter of transmittal will be sent to registered shareholders with instructions regarding the issuance of new post-consolidation share certificates.

Response Biomedical (Vancouver), announced that it has appointed Adapco, a distributor of mosquito control products and associated equipment in the US, as the sole US distributor for the company’s independently validated Ramp West Nile Virus (WNV) Test.

Magistral Biotech (Montreal) announced that on November 27, 2003 it filed a preliminary prospectus with the commission des valeurs mobilires du Qubec for the proposed offering of unsecured convertible debentures for minimum gross proceeds of $1.5 million and maximum gross proceeds of $5.75 million.

Angiotech Pharmaceuticals (Vancouver) announced its intention to implement a 2-for-1 stock split, subject to shareholder approval. The company will seek shareholder approval at a special meeting of the company’s shareholders, expected to take place on January 20, 2004.

VSM MedTech (Vancouver) announced that its board of directors has appointed Jack Price as the company’s CEO, effective immediately.

Neuro Discovery (Vancouver), a publicly traded biotechnology investment firm, said it launched NDI Life Sciences Fund, its second venture capital fund that is looking to raise $21 million. This fund will focus exclusively on British Columbia, unlike its first fund that targets all of North America.

ProMetic Life Sciences (Montreal) announced that its wholly owned UK subsidiary ProMetic BioSciences and Hemosol (Toronto) signed an important strategic agreement to implement the novel ProMetic/American Red Cross plasma protein purification process called Cascade for North America. Hemosol obtains North American Rights in Cascade with performances thresholds licensed to Hemosol in consideration for C$18 million plus royalties of 5 to 8% on sales of products.

TSO3 (Quebec City) and its North American distribution partner Skytron, have signed an agreement with Spectrum Health enlisting them as a technology showcase for its new ozone-based process for sterilizing medical instruments. This follows the recent clearance from the FDA for the product to be commercialized in the US.

ID Biomedical (Vancouver) announced that it has received additional funding from Dynport Vaccine relating to the development of a second-generation, subunit plague vaccine. The additional contract and amendments to the first contract will provide ID Biomedical with approximately US$4.5 million for further process development and manufacturing activities related to producing a subunit recombinant plague antigen under current good manufacturing practices.

Procyon Biopharma (Montreal) announced that it has been granted US patent no 6,656,965 relating to its antiretroviral program. The small molecule compounds described in the patent entitled “HIV protease inhibitors based on amino acid derivatives” constitute a novel family of compounds that demonstrate inhibitory activity against the HIV aspartyl protease and the whole virus in cell cultures.

ID Biomedical (Vancouver) announced that analysis of laboratory data from the company’s most recent influenza human challenge study of its non-live, intranasal FluINsure vaccine confirmed the efficacy of both the one- and two-dose vaccine regimens.

World Heart (Ottawa) announced the appointment of Mr John F Carlson and Mr William C (Bill) Garriock to its five-member board of directors completing the board restructuring announced on September 23, 2003.

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).