Life Sciences news briefs from Industry Canada

Ottawa, ON — April 24, 2003 — The following Life Sciences news briefs were published recently by Industry Canada:

1) Pharmaceuticals Update

Hemosol provides corporate update

Hemosol Inc (Toronto) announced that in order to perform a full safety and efficacy analysis of its cardiac trial (HLK 213/304) for its lead product Hemolink(TM) (hemoglobin raffimer), it will close enrolment at the current level of 152 patients, slightly lower than the originally planned enrolment of 180 patients. Hemosol suspended enrolment in the HLK 213/304 trial on March 13 following the company’s data and safety monitoring board’s (DSMB) observation of an imbalance in the incidence of certain adverse events between the Hemolink and control groups. Although limiting enrolment may decrease the planned statistical power of the findings regarding efficacy of the product, it will allow the DSMB’s observations to be fully and promptly investigated and for the company to assess the benefits of Hemolink in this trial. Provided any and all issues are resolved, the remainder of the Hemolink clinical development program can be re-initiated as early as possible. The company expects to conduct the analysis of the data within 60 days and plans to have the final safety database reviewed by an independent group of experts. Hemosol also issued layoff notices to most of its employees as the biotech company scrambles to save money in the wake of the setback for its Hemolink blood substitute. The company, which analysts warn could soon face a cash crunch, said the layoffs could take effect in two months, as it lowers spending not related to data analysis of revised trials. Hemosol employs about 130 people. Hemosol said it was also discussing merger and acquisition possibilities as well as the sale of some assets.

OncoGenex Technologies expands clinical evaluation of lead drug

OncoGenex Technologies Inc (Vancouver) announced the initiation of a second, planned phase I clinical trial of OGX-011 in combination with Taxotere(R) to treat patients with a variety of solid tumors. OGX-011 is currently in an additional Phase I trial in patients with prostate cancer. OGX-011 is an antisense drug being developed to sensitize tumors resistant to existing treatments such as chemotherapy. OncoGenex is co-developing OGX-011 with Isis Pharmaceuticals.

Dimethaid’s Pennsaid(R) equivalent to oral osteoarthritis drug

Dimethaid Research Inc (Toronto) will present results from a new osteoarthritis study to the European Congress of Rheumatology to be held in Lisbon, Portugal, June 18-21. The study, comparing the company’s topically applied Pennsaid(R) with a similar oral treatment, was conducted across Canada in a large group of patients suffering from knee osteoarthritis (OA). Lead investigator Dr Peter Tugwell, professor of medicine, Faculty of Medicine, University of Ottawa/Ottawa Hospital, will deliver an oral presentation of the results at the conference, expected to attract some 8,000 delegates representing medical specialists, industry insiders and patient advocacy groups from around the world.

Adherex releases new findings, seeks new patent

Adherex Technologies Inc (Ottawa) announced preliminary pharmacokinetic findings on Exherin from its ongoing Canadian Phase I Clinical Trial, new pre-clinical in vivo data with Exherin, and patent applications for a new generation of angiolytic compounds. Early results from the Exherin trial currently underway at the Ottawa Regional Cancer Centre demonstrated similar pharmacokinetics, or drug levels in the blood, in humans to that previously found in animals. Exherin is a member of a new class of anti-cancer agents called angiolytics. These drugs disrupt and destroy the tumor blood supply. Pre-clinical studies using animal tumor models have revealed that Exherin reduces tumor blood flow within 30 minutes of administration, and causes tumor blood vessels to rupture within one hour. Recent studies have shown that a continuous infusion of ExherinTM over a six-hour period causes tumor cell necrosis within 24 hours of administration in tumor bearing animals.

Lorus allowed canadian patent for novel antisense antimicrobial drugs

Lorus Therapeutics Inc (Toronto) announced that the Canadian Patent Office has allowed a patent, which protects a new component of the company’s antisense drug development program that shows promising antimicrobial activity. The patent titled, ‘Antisense Oligonucleotide Sequences As Inhibitors of Microorganisms,’ protects Lorus’ technology on the design and use of unique antisense, antimicrobial agents that target specific microbial gene sequences. The patent covers two gene targets, SecA and Ribonucleotide reductase (RNR), which are necessary for growth and viability of microorganisms. SecA is a central component of a process required for secretion of microbial proteins, which is an essential event in the life cycle of pathogenic organisms. RNR is a central enzyme in the formation of components required for DNA synthesis and repair in bacteria, fungi and viruses. The essential functions of these gene products make them ideal targets for drug development.

2) Diagnostics and Therapeutics Update

Pregnancy possible for some after fibroid procedure

New Canadian research provides women with hope that they can have healthy pregnancies following a procedure to shrink uterine fibroids called uterine fibroid embolization. Uterine fibroids can cause excessive menstrual bleeding, pelvic pain and interfere with fertility. The benign growths occur in about 25% of all women and are the leading cause of hysterectomy, or removal of the uterus, in the US. A relatively new procedure called uterine fibroid embolization can shrink fibroids, but it’s not clear how the procedure affects pregnancy. During the procedure, particles are injected into fibroid-feeding arteries, which essentially block the blood supply to the uterus and cause fibroids to shrink. Among a group of 555 women undergoing fibroid embolization, one-third of whom said they were interested in giving birth, 17 reported conceiving during the two years after the procedure. Some of the pregnancies ended in miscarriage, so that a total of 14 babies were born. Twelve of the women who eventually became pregnant after fibroid embolization had been childless, and would have stayed so if they had undergone hysterectomy, study author Dr Gaylene Pron of the University of Toronto in Canada told Reuters Health.

SYN X receives Health Canada approval for blood test for heart attacks

SYN X Pharma Inc (Toronto) announced that the company has received approval to market a 2-marker combination point-of-care (POC) test for rapid diagnosis of heart attacks. This new POC format compliments current heart attack tests marketed by SYN X and used in hospital labs and emergency rooms throughout Canada. This new cardiac license adds to SYN X’s current product portfolio, which includes Elisa and rapid point-of-care tests for infectious diseases, drugs of abuse, ulcers, traumatic brain injury and pregnancy. SYN X is now the only company to have Health Canada licenses for the entire spectrum of POC heart attack tests: a single marker Troponin I; a double-marker combination using Troponin I and Myoglobin; and a triple-marker combination with the addition of CK-MB.

3) Genomics Update

Two new European biochip patents granted to Helix BioPharma Corp

Two additional patents have been granted to Helix (Aurora) by the European Patent Office for its molecular sensing technology and heterodimer protein technology. These patents complement two previously announced US patents granted to Helix. Helix is using its patented Heterodimer Protein Technology and Molecular Sensing Technology in the development of biopharmaceutical research-based tools, including protein chips or “biochips”. These biochips are being designed for use by biopharmaceutical research companies, institutions and organizations in the study of protein interactions for the purpose of discovering and dev
eloping biopharmaceuticals and diagnostics.

DNA sequence of chromosome 7 decoded by Canadian-led project

Scientists at the Hospital for Sick Children (Toronto) have compiled the complete DNA sequence of human chromosome 7 and decoded nearly all of the genes on this medically important portion of the human genome. The research, which involved an international collaboration of 90 scientists from 10 countries, publishes in the online version of the scientific journal Science on April 10, 2003. Two years ago, a draft (or fragmented) human genome DNA sequence was published by the public Human Genome Project, and separately by Celera Genomics. To coincide with celebrations of the 50th anniversary of the discovery of the structure of DNA, the DNA sequencing phase of the Human Genome Project will be declared completed in April.

4) Medical Devices Update

MSI ships tuberculosis VScan test kits to the Philippines
Medical Services International Inc (Edmonton) announced that it will ship its VScan test kits for detection of tuberculosis (TB) to the Philippines. The test kits will be used in field-testing in remote areas where there are little or no medical facilities that can do traditional testing for TB. In the last several years TB has become prevalent in the Philippines. If the field-testing is successful, the company believes that this will open a large market in Southeast Asia for its VScan Rapid test for Tuberculosis (TB). The company has also had requests to increase its testing of the VScan HIV 1&2 in the Philippines. The company has agreed to ship enough samples of the HIV 1&2 test kits to meet the full testing protocol required for regulatory approval.

5) Industry Update

AEterna Laboratories Inc (Quebec City) announced the following appointments to its scientific advisory board: Dr Fernand Labrie, director of research at the CHUL Research Centre in Qubec City, Dr Klaus H.R. Diedrich, director of the department of gynecology and obstetrics of the University Clinic in Luebeck, Germany, as well as Dr Ren Frydman, director of the department of gynecology and obstetrics at the Antoine Beclere Hospital in Clamart, a suburb of Paris.

ChondroGene Limited (Toronto) reported that it has received a C$1.58 million payment from Pfizer Inc in conjunction with achieving the first research milestone in the joint Pfizer/ChondroGene target identification program for osteoarthritis (OA).

Generex Biotechnology Corporation (Toronto) announced that the Nasdaq listing qualifications department has notified the company that it is not in compliance with the requirements of NASD Marketplace Rule 4450(a)(3) for continued listing of its securities on Nasdaq’s National Market.

Inflazyme Pharmaceuticals Ltd (Toronto) and GlycoDesign Inc (Vancouver) announced that they have entered into a definitive agreement whereby Inflazyme has agreed to acquire GlycoDesign. Inflazyme will issue 22 million shares to acquire all outstanding GlycoDesign shares in a deal valued at approximately $12.8 million. The acquisition will expand Inflazyme’s franchise in inflammation and strengthen its product pipeline.

Draxima Ge Inc, the radiopharmaceutical division of Draxis Health Inc (Mississauga) has reached an amicable agreement with Cytogen Corporation for ending both their license and distribution agreement and their product manufacturing and supply agreement for BrachySeed(R) implants in the US.

Biovail Corporation (Toronto) and Flamel Technologies SA (Lyons) announced that they have entered into an agreement whereby Flamel has licensed to Biovail the exclusive North American rights to Flamel’s oral solid controlled release formulation of acyclovir for the treatment of episodic and recurrent genital herpes infections. Biovail intends to manufacture this novel form of the well-known and highly prescribed herpes treatment utilizing Flamel’s proprietary controlled release “Micropump Technology”.

MedMira Inc (Halifax) announced that it has received approval from the State Drug Administration of the People’s Republic of China for its MiraWell(TM) Rapid HIV Test. This test is the first and only rapid, point-of-care HIV test from Canada to fulfill the stringent clinical requirements of the Chinese regulatory body.

Axcan Pharma Inc (Mont St Hilaire) announced that it is commencing a cash tender offer of US$8.75 per share for all of the outstanding shares of common stock of Salix Pharmaceuticals, Ltd (NASDAQ: SLXP). The offer price represents a 40% premium to Salix’s average closing share price over the past 30 days and an aggregate value for Salix of approximately US$203 million.

Neurochem Inc (Saint Laurent) announced the appointment of Richard Cherney as a director of the company.

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).