News briefs from Industry Canada

Ottawa, ON May 16, 2003 The following news briefs were published this week by Industry Canada:

1) Pharmaceuticals Update

Procyon PSP94 efficacy data reported in prominent cancer journal

Procyon Biopharma (Montreal) announced its scientists and collaborators from McGill University published in the May 1st issue of Cancer Research, results showing the efficacy of Prostate Secretory Protein of 94 amino acids (PSP94) in reducing growth of rat prostate cancer cells in the rapidly growing MatLyLu rat prostate cancer model. Through the techniques of Hoechst staining, TUNEL assay and DNA laddering, the researchers also show clearly that PSP94 causes apoptosis (programmed cell death) of the cancer cells. In addition, the publication reports on the effect of PSP94 in reducing malignancy-associated hypercalcaemia, suggesting the potential role of PSP94 in the treatment of metastatic prostate cancer.

ConjuChem starts US trial for DAC:GLP-1

ConjuChem (Montreal) announced it has received clearance from the US Food and Drug Administration (FDA) to begin clinical trials in the US with its proprietary DAC:GLP-1 compound for the treatment of Type 2 diabetes. The first trial in the US, a Phase I/II study, will dose the first patient on May 27, 2003. The company has already initiated clinical studies for this compound in Europe.

Viventia Biotech initiates clinical trial with its first armed antibodies

Viventia Biotech (Toronto) announced that they have received approval from the Swiss regulatory agency, Swissmedic, to proceed with the initiation of a Phase I clinical trial to treat head and neck cancer patients at the University of Zurich Hospital, Zurich, Switzerland. The local ethics board approved the Phase I study last month. This is the first clinical trial to use one of Viventia’s Armed Antibodies targeted therapeutic drug candidates. VB4-845 is an antibody fragment conjugated with a toxin that targets a cell surface protein found in most head and neck cancers. Viventia’s Armed Antibodies approach has the ability to deliver potent cytotoxic agents directly to the tumors, avoiding healthy normal tissue, thereby sparing the patient some of the potentially debilitating side effects usually associated with other (Standard of Care) treatments.

Oncolytics Biotech reports enrollment has resumed in glioma study

Oncolytics Biotech (Calgary) announced that enrollment has resumed in the Phase I component of its clinical study examining the use of Reolysin in the treatment of recurrent malignant glioma, the most aggressive form of brain cancer. Changes to the clinical protocol were suggested by an independent data safety monitoring board, the study investigators, and Oncolytics to enhance the measurement of the safety and efficacy of Reolysin in the intended patient population in future studies. These changes have now been reviewed and approved by Health Canada.

2) Diagnostics and Therapeutics Update

ID Biomedical announces new data from Plague vaccine

ID Biomedical (Vancouver) announced that it has confirmed that nasal Proteosome-based vaccines protect against pneumonic Plague caused by lethal aerosol infection with virulent Plague bacteria in a mouse model of airborne dissemination. In a series of experiments performed by the US Army Medical and Materiel Command (USAMRMC) at Fort Detrick (Frederick, Maryland), in collaboration with ID Biomedical, mice nasally immunized with Plague antigen formulated with the Proteosome technology were completely protected against lethality (100%) even when the dose of Plague antigen was ten-fold lower than ever previously given nasally. Mice were 100% protected when challenged at either early or later times after only two nasal immunizations of the Proteosome Plague vaccine. In marked contrast, none of the control mice given nasal solution without vaccine antigen survived (0%) the lethal aerosol challenge with virulent Plague bacteria. High anti-Plague IgG antibodies in serum and high anti-Plague IgA levels in collected lung secretions were found at both early and late time points post-immunization with the nasal Proteosome-based Plague vaccine. These levels were 10-200 times the low levels of these antibodies detected when the Plague antigen was given nasally without the Proteosome-based technology.

New clinical data confirm role of Visudyne (Verteporfin) T

QLT Inc. (Vancouver) and Novartis Ophthalmics, the eye health unit of Novartis AG, announced new data presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting suggest that Visudyne therapy reduces the risk of vision loss in “wet” age-related macular degeneration (AMD) patients with minimally classic lesions, a form of wet AMD previously considered untreatable. Additional data to support the role of Visudyne in patients with predominantly classic AMD demonstrate that visual outcomes continue to remain stable five years after initiating therapy, providing further evidence of the safety and long-term efficacy of Visudyne.

ID Biomedical announces positive results for StreptAvax vaccine

ID Biomedical (Vancouver) announced that preliminary results from the first cohort of its Phase II Clinical Trial of the StreptAvax vaccine indicated that the immunogenicity of the vaccine was highly significant. The data showed the subunit vaccine generated antibody responses that were similar to the Phase I results in both magnitude and breadth. The median rate of seropositivity after immunization was 25 of the 26 M serotypes contained in the vaccine. The current Phase II study is evaluating the safety and immunogenicity of StreptAvax in an expanded number of adults. The trial is randomized, blinded, and comparator-controlled, using a licensed hepatitis A vaccine. The current clinical trial is providing data on the performance of StreptAvax given on a schedule identical to that used for the hepatitis A vaccine which will be used as a comparator in future pediatric studies.

3) Medical Devices

Reveal rapid HIV-1 antibody test indicates 100% sensitivity in study

MedMira (Halifax) announced that Brown University (Providence, Rhode Island) in conjunction with Walter Reed Army Institute of Research (Rockville, Maryland) has completed an independent sensitivity study of MedMira’s Reveal rapid HIV-1 antibody test. The results of this study indicated a sensitivity of 100% to all specimens collected from the one hundred HIV infected participants recruited from the Immunology Clinic of the Miriam Hospital. The Reveal rapid HIV-1 antibody test has very recently received a pre-market approval from the US Food and Drug Administration.

Nexia initiates a cost-reduction program

Nexia Biotechnologies (Montreal) announced that it is implementing a cost-reduction program to preserve financial resources as a result of the recent delays in the development of a commercial spinning process for BioSteel. The implementation of this program involves the reduction in: the number of employees by approximately 30%, farm operations, early R&D programs, and administrative and other non- essential expenses. Upon completion of the restructuring program, Nexia expects that its monthly net cash outflow will be reduced from $1 million to approximately $600,000 thereby extending its financial resources until October 2005. It says all core activities associated with the BioSteel spinning development program and Protexia program will remain intact.

AI Software acquires patented stem cell expansion technology

AI Software (Vancouver) announced that is has reached an agreement with the Weitzman Institute of Science and Technion Israel Institute of Technology to acquire the exclusive rights of stem cell expansion technology. Medical experts stated that the patented technology currently in its developmental stages could be pivotal in enabling cord blood transplants in adults.

CryoCath receives FDA 510(k) clearance for Freezor Xtra

CryoCath Technologies (Montreal) announced that its Freezor
Xtra surgical cardiac cryoablation device has received 510(k) clearance from the US Food and Drug Administration, allowing the Company to launch its third product into the US Freezor Xtra will allow physicians to surgically treat cardiac arrhythmias in the pericardial space by minimally invasive surgical techniques or directly during surgical cardiac procedures.

4) Genomic Update

McGill University Health Centre success of chemotherapy tied to genetics

Genetics may play a role in the success of anti-cancer therapy, according to researchers at the Research Institute of the McGill University Health Centre and the Lady Davis Institute for Medical Research of the Sir Mortimer B Davis – Jewish General Hospital in Montreal. Their study, published in today’s issue of Clinical Cancer Research, shows that some colorectal cancer patients with a particular gene mutation respond much better to therapy than those without this genetic change.

5) Industry Update

CryoCath Technologies (Montreal) announced that Texas Heart Institute (THI) became the first US center to commercially acquire the company’s recently approved Freezor CryoAblation system. On May 2, THI’s Dr John Seger successfully performed the first US transcatheter cryoablation procedure in a 32-year-old female with AVNRT, after FDA approval for commercial release was granted the previous week.

Celmed BioSciences(Montreal), a subsidiary of Theratechnologies which is engaged in the field of cell therapy, announced the appointment of Mark Kaufmann to the newly created position of vice president, corporate development.

The Helen Keller Foundation for Research and Education presented QLT (Vancouver) and Novartis Ophthalmics, the eye health unit of Novartis AG the 2003 Helen Keller Prize for Innovation in Eye Care for their development of Visudyne (verteporfin for injection) therapy.

Biomira (Edmonton) and its chairman, Eric Baker, announced the appointment of Richard L Jackson, PhD, to its board of directors.

BioAxone Therapeutic (Montreal) recently appointed Dr Nigel Brown as chairman of the board of directors.

Spectral Diagnostics (Toronto) announced it has signed an exclusive distribution agreement with the medical products and services group of Cardinal Health (NYSE:CAH) to distribute Spectral’s rapid diagnostic products to health-care providers in the US.

Fytokem Products (Saskatoon) announced that it has received regulatory approval and has completed the transaction previously announced on April 11, 2003 to convert $90,100 of debentures held by the Agri-Food Equity Fund (AFEF) into Equity.

Redasoft (Toronto) announced that United Bioinformatica will provide the exclusive distribution of Redasoft’s Visual Cloning 3 software to Canadian life science researchers. Today’s announcement is the first in what Redasoft anticipates will be a series of international partnerships that will give distributors the ability to provide a value-added product that will enable researchers to make their research extraordinary.

Triax-Covington’s (Toronto) New Generation Biotech Funds announced the investment of $9.2 million in eight Ontario-based biotechnology and health care companies positioned to capitalize on the commercialization of discoveries from two of North America’s largest research communities located in Toronto and Ottawa.

Neurochem (Saint Laurent) and Innodia announced an agreement whereby Neurochem has licensed to Innodia its intellectual property rights relating to Neurochem’s pre-clinical diabetes project in exchange for an important stake in Innodia.

Fytokem Products announced that its director of research and development, Janice McColl, will resign her position effective May 31, 2003.

Dragon Pharmaceutical (Vancouver) announced that it has received market approval from the Chinese State Drug Administration for the use of rHu Erythropoietin in surgical patients in China and a new dosage presentation of 6000 IU which will be used for this new indication.

Biovail (Toronto) announced that it has achieved favorable formulary coverage for recently launched Cardizem LA. Biovail has signed agreements giving Cardizem LA a favorable formulary position with a number of pharmacy benefits managers and managed care organizations providing prescription healthcare services for about 74 million individuals in the US.

IBEX Technologies (Montreal) announced that it has signed a definitive agreement to acquire Oncotherapeutics, a privately held company that owns exclusive rights to an extensive portfolio of promising cancer biomarkers, discovered at Mt Sinai Hospital, for $730,986 plus milestone payments.

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).