Life sciences news briefs from Industry Canada (April 23, 2004)

Ottawa, ON – April 23, 2004 – The following life sciences news briefs were published this week by Industry Canada.

1) Pharmaceuticals Update

ConjuChem reports positive interim Phase II DAC:GLP-1 results

ConjuChem (Montreal) announced interim results from its ongoing monotherapy Phase II clinical trial that is evaluating the company’s proprietary compound DAC:GLP-1 to treat type 2 diabetes. “All of the data available from patients who have completed the first 28 days therapy in this study substantiates the results seen in our Phase I/II multi-dose trial with a much larger population of patients that more closely resemble typical patients with Type 2 diabetes,” said Dr Jean Paul Castaigne, chief scientific officer and vice president of ConjuChem. “In particular, to observe a 0.8% reduction of HbA1c (A1c) after only a month of monotherapy with DAC:GLP-1 is very encouraging.”

Tests prove Viralex kills Norwalk virus surrogate

Alda Pharmaceuticals (Vancouver) announced that Viralex with T(3)6 has been shown to be 100% effective within 3 minutes against the accepted test substitute for Norwalk virus. The tests were conducted on Feline Calicivirus at an independent laboratory in the US. Norwalk and Norwalk-like viruses are members of the family Caliciviridae and are the leading cause of gastroenteritis in humans. The human Norwalk virus cannot yet be grown in tissue culture and testing requires the use of the closely related feline equivalent. This latest test complements the recent successful test against Legionnaires’ disease that was also completely killed by Viralex within 3 minutes.

Neurochem announces additional positive results

Neurochem (Montreal) reported additional positive interim data on cognitive function in 18 patients with mild-to-moderate Alzheimer’s disease (AD). The results relate to patients who have completed both the three-month randomized Phase II clinical trial and an additional 13 months of treatment in the open-label Phase II extension study with the investigational product candidate, Alzhemed. The data is based on cognitive function as measured by the ADAS-cog test. Out of the 30 AD patients who had previously completed 12 months of treatment on Alzhemed, Neurochem is reporting on the 23 mild-to-moderate AD patients who have received the product candidate for 16 months. The mild-to-moderate AD patients (n=18) showed an average ADAS-cog score of +2.33 points, as opposed to +9.65 points on average in comparable historical controls with AD patients. The mild AD patients (n= 11) responded the best and showed a change from baseline in their average ADAS-cog score of -0.09 points. This result compares favorably with a score of +7.62 points on average in comparable historical controls. Five patients discontinued the treatment but not for reasons of drug-related adverse events. The company will report on the seven other patients later once they complete 16-months of treatment with Alzhemed. Overall 82% of the mild AD patients had stabilized or improved cognitive function tests even after 16 months of treatment with Alzhemed.

Completion of milestone triggers Protexia drug development

Nexia Biotechnologies (Montreal) announced the successful completion of the pharmacokinetic (PK) studies for Protexia – the final pre-development milestone. These studies, conducted by the US Army’s Institute for Chemical Defense and Defence R&D Canada-Suffield, confirmed an appropriate PK profile for Protexia in experimental animal models. The technical results will be presented at the Medical Defense Biosciences Review Conference on May 16, 2004. Completion of this milestone triggers the Protexia drug development program including; transgenic herd scale-up, good manufacturing practices purification process development and completion of the pre-clinical studies to support the filing of an investigational new drug exemption with the US FDA.

Ecopia BioSciences announces the discovery of two new compounds

Ecopia BioSciences (Montreal) announced the discovery of two more compounds, ECO-13901 and ECO-26301, using its proprietary Decipher technology. These two new entities have novel chemical characteristics and biological activities that make them interesting potential drug candidates. This brings to seven the total number of new compounds discovered using Ecopia’s decipher technology. The powerful proprietary technology platform was developed by Ecopia and allows the discovery of potential new drugs from bacteria using sophisticated technology. By scanning microbial DNA, the technology can predict the structure of the compound, which provides important information for the company’s chemists to isolate and purify the potential new drug.

2) Diagnostics and Therapeutics Update

Theratechnologies reports Phase II results for ThGRF

Theratechnologies (Montreal) announced results for its Phase II clinical trial, testing ThGRF in patients with HIV-associated lipodystrophy, a medical condition characterized by body composition changes and metabolic abnormalities. Highlights include a good safety profile, a clear positive effect on body composition and a clinically relevant reduction in visceral fat while subcutaneous fat was preserved. While this selectivity of action on fat distribution appears to have prevented the study from meeting one of its primary endpoints, it likely would be an advantage in treating HIV-associated lipodystrophy patients who generally experience an accumulation of visceral fat (lipohypertrophy), associated with higher risk of cardiovascular disease, coupled with a loss of subcutaneous fat (lipoatrophy). Of particular importance in this study was good glycemic control, including in glucose-intolerant and diabetic patients, who represented 28% of the subjects enrolled. It is estimated that approximately 40% of all HIV-associated lipodystrophy patients are either glucose intolerant or diabetic.

3) Medical Devices

Angiotech extends exclusive licensing agreement with Poly-Med

Angiotech Pharmaceuticals (Vancouver), a specialty pharmaceutical company focusing on drug-coated medical devices and biomaterials, announced that it has licensed a portfolio of biomaterial, drug delivery, and medical device technologies from Poly-Med. This agreement will expand Angiotech’s relationship with Poly-Med, a developer of biomaterial technologies, which it initially formalized in a June 2001 licensing agreement.

ART announces in vivo data

ART Advanced Research Technologies (Montreal), a developer of optical imaging technologies, announced the results of in vivo research and development studies at the 2004 IEEE International Symposium on Biomedical Imaging which is being held in Arlington, Virginia, with ART’s eXplore Optix time-domain small animal molecular imaging system. The studies were conducted at LAB Preclinical Research International in Laval, and at ART by both ART researchers and external investigators. The results, being presented by Dr Fridiric Lesage of ART, demonstrate the achievement of an explicit, local estimation of fluorescence and a separation of fluorescent signals of different lifetimes in the same scan. Using time domain small animal molecular imaging, target and endogenous fluorescence are distinguished, providing better three-dimensional

4) Genomic

University Of Toronto researchers isolate gene for Crohn’s disease

Researchers at the University of Toronto have isolated a gene that predisposes people to Crohn’s disease. “Isolating this gene is a critical step towards improved diagnosis of this disease and developing better therapies for Crohn’s sufferers,” says Katherine Siminovitch, a U of T professor with the department of medicine. “There’s an urgent need for better treatment for patients with Crohn’s.” Using DNA samples from family groups, Siminovitch and her research team employed a technique called positional cloning to first locate the chromosome containing the gene and then identify the gene. The gene isolated by the researchers produc
es a protein that sits on the cell surface and regulates how substances enter and exit the cell. In a majority of Crohn’s disease patients, this protein functions improperly and allows toxins easier access to the cell.

OHRI has determined the way cells die when exposed to ultraviolet light.

In an article published in Proceedings of the National Academy of Sciences, a prominent US science publication, Dr Bruce McKay – associate scientist in cancer research at the OHRI, scientist at the Ottawa Regional Cancer Centre, assistant professor at the University of Ottawa as well as research scientist of the Canadian Cancer Society – elaborates on this important discovery, which could in turn alter the treatment of cancer. More than half of all tumours carry mutations in the p53 tumour suppressor, making it the most commonly altered protein in cancer. The p53 protein is an important regulator of the response of cells to DNA damaging agents that cause cancer and those that are used to treat cancer. In general, cells exposed to low levels of DNA damage are able to recover and survive the insult but highly damaged cells are eliminated through a form of programmed cell death called apoptosis. How the extent of DNA damage is sensed and how the cells ultimately decide to live or die following DNA damage has been unclear. Using ultraviolet light as a model DNA damaging agent, Dr McKay and his team have uncovered a novel form of gene regulation that appears to influence the cell’s decision to live or die in response to DNA damage induced by UV light, and probably other agents as well.

Canadians receive $123 million for genome research

Canadian genomic scientists will share $123 million in research funding for new applied health technologies, a federal agency announced Tuesday. Genome Canada is launching 14 new large-scale projects across Canada that were reviewed by an international scientific panel. The projects aim to develop tools to improve the prediction, prevention and treatment of human disease, said Dr Martin Godbout, president and CEO of Genome Canada.

5) Industry Update

Xenon Genetics (Vancouver) announced that it was awarded C$4.7 million in funding from Genome Canada and Genome British Columbia to develop improved screening, diagnostic tests and therapeutic treatments for common iron metabolism disorders. Matching funds for the three-year project will be provided by Xenon.

Having reached its objective of $4 million at the second closing on March 31 last, Magistral Biotech (Montreal) is extending the issuance of its unsecured convertible debentures to May 15, 2004, with a new objective of $5.75 million.

Cancer is the number one cause of early death in Canada, according to Canadian Cancer Statistics 2004 released today by the Canadian Cancer Society.

Medical Services (Edmonton) announced that it has received the independent test results of its VScan HIV 1&2 test kits from Hainan Province in the Peoples Republic of China. The testing was 99.7% accurate in terms of specificity and sensitivity. The VScan HIV test kit continues to show excellent results in all testing situations.

Cytovax Biotechnologies (Edmonton) announced that its board of directors has approved a plan to restructure its operations. The plan adopted by the board calls for the completion of work on the company’s internal R&D activities by the end of May, when staff will be reduced by 80%. After that time, the company’s product candidates may be further developed through partnerships and/or external resources.

Topigen Pharmaceuticals (Montreal) announced that it has received approval of their clinical trial application with Health Canada to begin human clinical trials of its lead product, ASM8, an antisense medication for the treatment of mild, moderate and severe asthma.

Micrologix Biotech (Vancouver) has agreed to acquire San Diego-based MitoKor (San Diego), a privately held biotechnology company focused on the research and development of drugs for the treatment of major medical conditions related to mitochondrial dysfunction MitoKor has clinical and preclinical product candidates in Alzheimer’s, arthritis, Parkinson’s, and other diseases.

Life Sciences News Briefs 2004 is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Sandy Vien; Tel: 613-941-6479; E-mail: vien.sandy@ic.gc.ca).