Life sciences news briefs from Industry Canada (June 24, 2003)

Ottawa, ON — June 24, 2003 — The following life sciences news briefs were published recently by Industry Canada.

1) Pharmaceuticals Update

Axcan Pharma Seeks Injunction Against Salix

Axcan Pharma (Mont St-Hilaire) filed a motion in the United States District Court for the District of Delaware seeking a temporary restraining order against Salix Pharmaceuticals, relating to alleged violations of the US securities laws. Axcan also has requested permission to file a second amended complaint in the United States District Court for the District of Delaware with respect to these alleged violations.

AnorMED announces senior management changes, Fosrenol results

AnorMED (Vancouver) announced a restructuring of the senior management team effective July 1, 2003. Dr Geoffrey Henson will leave his role as chief operating officer and will work with AnorMED in an advisory capacity. Dr Christen Giandomenico, will leave his role as vice president development to pursue other opportunities. Dr Gary Bridger, chief scientific officer of AnorMED will have new responsibilities in development and will assume the position of vice-president research and development. Other business and operational responsibilities will assigned to appropriate members of AnorMED’s senior management team. AnorMED also announced that Fosrenol (lanthanum carbonate), a candidate phosphate binder for use in end-stage renal disease (ESRD) patients, licensed to Shire Pharmaceuticals Group, has become the first non-calcium phosphate binder to demonstrate sustained efficacy and a good safety profile during three years of treatment, according to new data presented at the World Congress of Nephrology.

YM BioSciences announces results for TheraCIM h-R3, Norelin

YM BioSciences (Mississauga) announced results from a Phase I/II open-label dose finding study for TheraCIM h-R3 in head and neck cancer. This trial was conducted at multiple centers in Canada. The trial was designed to study TheraCIM h-R3 when used in combination with radiation therapy for the treatment of unresectable locally advanced head and neck cancer. Analysis of data collected to date demonstrated a complete tumour response in 9/12 patients who received 200mg of TheraCIM h-R3 and 8/12 patients who received 100mg given once weekly for six weeks with standard radiation therapy. Dr Paul Keane, director of medical affairs of YM BioSciences, commented, “The response rates for TheraCIM h-R3 combined with radiation were equivalent to those achieved with chemoradiation, while sparing the patient of the associated toxicities of chemotherapy. These data suggest that the optimal biological dose for TheraCIM may be significantly lower than those reported for other antibodies to the EGF receptor. Consequently, we are currently reviewing the protocol with a view to investigating the effectiveness of yet lower doses.” YM BioSciences also announced preliminary results from its safety and immunogenicity trial of Norelin, a therapeutic cancer vaccine for the treatment of hormone dependant prostate cancer. The study was designed to evaluate the safety of the vaccine and to determine if an immune response against gonadotropin-releasing hormone could be generated.The preliminary results indicated that the vaccine was very well tolerated, with no major (Grade 3 or 4) adverse events reported. Preliminary evidence of immune response was found in seven out of 12 (58.3%) patients.

ConjuChem reports positive preliminary DAC(TM):GLP-1 results

ConjuChem (Montreal) announced positive preliminary results from the four ongoing Phase I/II clinical trials for its proprietary DAC: GLP-1 compound indicated for the treatment of type 2 diabetes. In both single and multi-dose subjects, the compound has been well tolerated with no serious adverse events related to the compound reported and no injection site irritation. Consistent with side effects seen with other GLP-1 compounds, mild nausea and vomiting in some subjects was observed, more so in healthy volunteers than patients. However, a low oral dose of metoclopramide was able to effectively control these symptoms. Moreover, in the multi-dose study, where only two cases of nausea were reported in the patient population, this symptom substantially decreased or was eliminated with repeat administration (tachyphylaxis).

2) Diagnostics and Therapeutics Update

Researchers discover new class of human stem cells

Scientists with University Health Network (Toronto) have discovered a new class of human stem cells that rapidly grow when implanted in the bone marrow of mice. The findings, available in an advance on-line publication of the international scientific journal Nature Medicine, are a major advancement in human stem cell research with possible significant clinical implications for designing more effective cancer therapies. The scientists identified the new stem cells after injecting a batch of stem cells directly into the bone of mice, instead of the traditional method of intravenous injection into the blood stream. They observed this new subpopulation of stem cells rapidly repopulate the blood-producing system of the mice, produced high levels of blood cells within the first week or two after transplant, which is one- to two-weeks earlier than the normal rate. This discovery builds on the Dr Dick’s pioneering method of studying human stem cells by transplanting them into immunodeficient mice which will not reject the human cells.

New range of antibiotics may present a threat to public health

A remarkable range of antibiotics under development may compromise our natural defences against infection, warns McGill University (Montreal) evolutionary biologist Graham Bell. His paper, entitled Arming the Enemy: the evolution of resistance to self-proteins and co-authored by Pierre-Henri Gouyon, was published in the journal Microbiology this week. The new antibiotics are attracting increasing interest as a major new weapon in the campaign against bacterial infection, even though both experimental evidence and theoretical arguments suggest that this claim is doubtful, according to their paper. “It is claimed that bacteria will be unable to evolve resistance to them because they attack the “Achilles’ heel’ of bacterial cell-wall structure,” explains Dr Bell. However, if this is true, “the introduction of these substances into general use may provoke the evolution of resistance to our defence proteins.”

Procyon announces FDA clearance for Fibrostat trial

Procyon Biopharma (Montreal) announced that the US Food and Drug Administration (FDA) has issued clearance to commence the North American clinical phase IIb trial for Fibrostat, a topical therapeutic cream for the treatment of excessive scarring. This placebo-controlled, double-blind, randomized study will enroll 200 patients in seven centers with extensive expertise in wound healing across Canada and the US.

MedMira launches rapid vaccinia antibody detection test

MedMira (Halifax) announced the launch of its patent-pending Mirawell rapid vaccinia antibody detection test into the international marketplace. This test is the latest commercial development in the company’s increasing line of rapid in vitro diagnostic products. The MiraWell rapid vaccinia antibody detection test detects antibodies to the vaccinia virus (the vaccine against smallpox) in human blood to determine the effectiveness of an individual’s vaccination. Vaccination against smallpox has also been shown to provide immunity against other viruses from the orthopox virus family (including monkeypox). The primary function of the MiraWell rapid vaccinia antibody detection test is to test for the presence vaccinia antibodies in individuals that do not show a visible response to vaccination against smallpox. MedMira’s target market for this product is in clinical settings where smallpox vaccinations are performed.

3) Medical Devices

ART starts clinical trial with Sunnybrook and Women’s College

ART Advanced Research Technologies (Montr
eal), a developer of optical imaging technologies, and Sunnybrook and Women’s College Health Sciences Centre, have announced the start of a multi-centre clinical trial for ART’s SoftScan optical breast imaging device, of which Sunnybrook and Women’s is the first approved clinical site. Imaging of up to 200 study volunteers at Sunnybrook and Women’s is expected to begin in mid-June and will be completed over the next year. ART has received approvals, from both Health Canada and the Sunnybrook and Women’s, Research Ethics Board, to begin this clinical study entitled Optical Characterization of Breast Tissue. Dr Roberta Jong, radiologist and director of breast imaging at Sunnybrook and Women’s, will be acting as principal investigator of this first clinical collaboration between Sunnybrook and Women’s and ART. The objective of this study is to acquire biological data on a broad range of breast tissue, including targeted breast lesions. This data will be used in the final development of the SoftScan image processing system and to characterize the signatures of malignant and benign breast lesions for diagnostic purposes.

4) Genomic Update

First Genetic Trust and Galileo Genomics announce strategic collaboration

First Genetic Trust and Galileo Genomics (Montreal) have announced a collaboration to provide innovative pharmacogenomics research capabilities to the pharmaceutical and biotechnology industry. The collaboration will create an unprecedented research resource of large-scale clinical networks from Quebec and the US. The collaboration will provide innovative and targeted pharmacogenomics services across a wide range of key therapeutic areas, including inflammation and immunological diseases, cardiovascular and metabolic diseases, and CNS/psychiatric disorders. Galileo Genomics will provide derived data from its extensively phenotyped patients from the Quebec founder population as well as other global founder populations. The genetic characteristics of these founder populations make them ideal for efficiently identifying genes and pharmacogenomic markers associated with disease and drug response.

5) Industry Update

Medicure (Winnipeg), a cardiovascular drug discovery and development company, is pleased to announce today that Dr Robert G Burford, PhD, FACA has been appointed to the position of vice president, product development. Dr Burford will focus his efforts on advancing the development of the company’s new product, MC-4232.

MDS Sciex, the analytical instrumentation division of MDS (Toronto) and SC BioSciences Corporation, a provider of innovative products and services that span the drug discovery process, today announced the signing of an exclusive distributorship agreement to deliver MDS Sciex’s new NanoLC Proteomics system in Japan.

MedMira (Halifax) announced that it has completed arrangements for a $625,000 loan facility with Dr Martin Giuffre of Edmonton, Alberta.

Medical Ventures (Richmond), announced the appointment of Zvi Boms to the board of directors.

Oncolytics Biotech (Calgary) announced that it has been granted US Patent 6,576,234 entitled “Reovirus for the Treatment of Neoplasia.” Allowed claims in this patent cover the use of combinations of reovirus strains for the treatment of Ras-mediated tumours.

MIV Therapeutics (Vancouver) announced the commencement of trading on the Berlin Stock Exchange under the symbol MIV.BE and German Cusip No.798618.

Specialty pharmaceutical developer Dimethaid Research (Toronto) announced that its distribution partner, Italchimici, has officially launched Pennsaid in Italy. Dimethaid’s first commercial product will be promoted as a treatment for osteoarthritic pain in superficial joints – competing against other topical anti-inflammatory drugs (NSAIDs) and oral formulations in the Italian market estimated to be worth a total (euro) 470 million.

Labopharm (Laval) announced that it has fully completed enrolment of more than 1,000 patients for two pivotal Phase III trials in the US for the company’s lead in-house product, a once-daily version of the analgesic tramadol.

Angiotech Pharmaceuticals (Vancouver) was notified by its corporate partner, Boston Scientific Corporation, of its intention to file with the US Food and Drug Administration (FDA) the fifth and final module of its pre-market application for its TAXUS Express(2) paclitaxel-eluting coronary stent system on or about June 23.

ConjuChem (Montreal) announced that, effective July 15, 2003, Jacques Lapointe will assume the position of interim president and chief executive officer. Since November 2002, Mr Lapointe has served as chairman of the board and will also continue in this role.

VSM MedTech (Vancouver) announced that it was presented with the “Emerging Company of the Year” award at the annual BC Technology Industries Association (BCTIA) gala event, held in Vancouver.

Inflazyme Pharmaceuticals (Vancouver) announced the appointment of Joseph M. Davie, M.D., PhD to its board of directors.

Ecopia BioSciences (Montreal) announced the discovery of its fourth new chemical entity. This compound, called ECO-02201, is a novel molecule with anticancer activity. The most interesting aspect of this new addition to Ecopia’s pipeline is that the presumed pharmacophore of ECO-02201 is different from previously known compounds. This novel compound was found to have cytotoxic activity when tested in vitro on human cancer cells.

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).