Life Sciences News Brief
Vol. 5 no. 20 - June 29, 2005
　

Stressgen completes manufacture of HSPE7 for use in RRP Phase III study

Stressgen Biotechnologies (Victoria) announced that it has completed the manufacture of HspE7, which will allow for the release of HspE7 for use in the RRP Phase III clinical study in the next several months. As a result, the Company plans to begin a Phase III study in recurrent respiratory papillomatosis (RRP) in the first quarter of 2006, pending review by the U.S. Food and Drug Administration. The study will include multiple doses to assess the safety and efficacy of HspE7 in patients with RRP. Efficacy will be measured by increases in intersurgical interval. Because of the change in the biological profile of the newly manufactured HspE7, the Company does not expect to gain concurrence from the FDA under a Special Protocol Assessment (SPA). In addition, the Company will be developing an additional HspE7 product that incorporates the reformulation of the compound with an adjuvant. The Company expects to be prepared to begin a Phase I/II proof-of-concept study with this product in the first quarter of 2006.

Nausea Drug Fails Against Cirrhosis-Linked Fatigue

Even though it's often used to fight chemotherapy-linked nausea, the drug ondansetron has proven ineffective at treating fatigue in people with cirrhosis of the liver, according to a new report. The study, led by Dr. Jeremy Theal of the University of Toronto, included 54 patients with primary biliary cirrhosis (PBC) who received the drug for a four-week period and also received a placebo for a different 4-week period. The researchers concluded the drug did not reduce fatigue any better than the placebo. In addition, neither the drug nor placebo produced significant changes in either the patients' depression or sleep quality. The Canadian team believes other drugs that target the central nervous system may be effective in treating fatigue associated with PBC, an inflammation of the bile ducts in the liver that leads to cirrhosis. Fatigue is a symptom in up to 85 percent of PBC patients and affects their quality of life and limits their activities. Several drugs have been tested as treatments for PBC-related fatigue, but none have proven effective so far. The findings appear in the June issue of the journal Hepatology.

Generex Presents Oral-lyn(TM) Clinical Trial Results

Generex Biotechnology Corporation (Toronto), a leader in the area of buccal drug delivery, announced clinical trial results in respect of Oral-lyn(TM), the Company's proprietary oral insulin buccal spray formulation. The interim results, after 8 weeks of treatment, showed no change in fasting glucose while in post-prandial glucose there was a 15.4% reduction in the Oral-lyn(TM) group versus 3.9% elevation in the placebo group. Furthermore, the study found a reduction of fructosamine in the Oral-lyn(TM) group of 6.4% versus 3.6% in the placebo group and for HbA1c there was a 6.6% reduction in the Oral-lyn(TM) group versus 3.4% in the placebo group. The effective post-prandial trend can be seen clearly, although the results are not statistically significant. This may be partially due to the short time period and small sample size of the study. The study concluded that in patients with Type-2 diabetes maintained on Glargine and Metformin, Oral-lyn(TM) was especially effective in controlling post-prandial glucose excursions.

Advitech announces completion of its 2nd study on XP-828L

Advitech Inc. (Quebec City) a Canadian biotech company, announced the completion of the treatment phase of the double-blind, placebo-controlled, randomized clinical trial for XP-828L, its new oral treatment for mild-to-moderate psoriasis. The main objective of this study is to confirm the efficacy and the safety of XP-828L. In 2004, Advitech conducted a first open-label study on XP-828L for psoriasis, and the results were encouraging. The current study was jointly conducted by Robert Bissonnette, MD, and Yves Poulin, MD, two leading dermatologists who have been involved in several clinical studies for the treatment of psoriasis. This multi-centre, randomized double-blind, placebo-controlled study was conducted over a 112-day period. The study protocol involved two groups: a placebo group, and a second group, in which the patients received a single dose of XP-828L for 56 days. During the 56 days of the double-blind study, the placebo group was then administered a double dose of XP-828L, while the second group remained on the initial single dose of XP-828L.

Allon Therapeutics product AL-108 successful in Phase Ia clinical trial

Allon Therapeutics Inc. (Vancouver), The Neuro Protection Company(TM), announced that a Phase Ia human clinical trial of the company's first product AL-108 has demonstrated that a single dose administered at up to 15 milligrams was safe and well tolerated in healthy adults. AL-108 is being developed as a treatment for Alzheimer's disease. Gordon McCauley, President and CEO of Allon, said the next step in the clinical evaluation of AL-108 is a Phase Ib clinical trial with healthy elderly subjects scheduled to begin in Q3 2005. The trial is expected to be completed in Q4 2005 and results available early in Q1 2006.

Positive Preclinical Data with Novo Nordisk A/S Long-Acting GLP-1

Transition Therapeutics Inc. (Toronto) announced that positive pre-clinical data with the combination of Novo Nordisk A/S' long-acting GLP-1 analogue, liraglutide, and gastrin was presented at the American Diabetes Association annual conference in San Diego, California. In a three week study using a type 1 diabetic animal model, daily doses of liraglutide or the combination of liraglutide and Transition's gastrin analogue, G1, were able to return diabetic mice to normal blood-glucose levels and achieve a several-fold increase in both the pancreatic insulin content and beta cell mass. The addition of gastrin, G1, potentiated liraglutide effects. "These findings demonstrate the potential use of a long-acting GLP-1 analogue and gastrin to stimulate islet cell regeneration and expand the use of GLP-1 therapy to insulin-dependent diabetes patients." said Dr. Tony Cruz, chairman and CEO of Transition.

MIGENIX Inc Reports Effectiveness Of MX-2401 In Pneumonia Model

CryoCath's U.S. Trial for Atrial Fibrillation Underway

CryoCath Technologies Inc., (Montreal) the global leader in cryotherapy products to treat cardiovascular disease, announced the first patient was treated in its Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF), an Investigational Device Exemption (IDE) trial using its proprietary Arctic Front(TM) catheter for Atrial Fibrillation (AF). Dr. Douglas Packer, from Mayo Clinic, Rochester, Minnesota, and the principal investigator of this study, performed the procedure. The procedure resulted in an acute success, with all four pulmonary veins electrically isolated using only the Arctic Front catheter. Three of the four veins were electrically isolated with one lesion application. There were no complications or safety concerns arising from the procedure. The patient was diagnosed with AF several years ago and anti-arrhythmic medications have failed to control his condition.

Andromed announces conclusive clinical study results on Androflo(TM)

Andromed Inc. (Montreal), an innovative medical technology company, announced positive results of its multi-centre clinical study on Androflo(TM), an accurate, non-invasive and non-obtrusive respiratory rate monitor. The results of the study show that the Androflo(TM) may be the first truly reliable clinical tool for continuous monitoring of patient breathing, without requiring the use of a facemask or nasal cannulae. Based on the study's conclusive results, Andromed will submit a 510(k) premarket notification to the FDA and expects to receive marketing clearance by the fall of 2005.

Bioniche Presents Data on Anticancer Activity

Bioniche Life Sciences Inc. (Belleville), a research-based, technology-driven Canadian biopharmaceutical company, presented data from a study using the Company's proprietary Mycobacterial Cell Wall-DNA Complex (MCC) against peritoneal (colon) cancer in rats. The data was presented at the 7th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The study, co-authored by Dr. Nigel C. Phillips, Chief Scientific Officer and Dr. Mario C. Filion, Head of Biomedical Research at Bioniche Life Sciences Inc., evaluated the in vitro activity of MCC against DHD/K12/PROb cells, and the in vivo activity of MCC against DHD/K12/PROb peritoneal carcinomatosis in rats. Dr. Filion stated, "MCC has direct anticancer activity against PROb cells, as demonstrated by its ability to inhibit proliferation and induce apoptosis."

WorldHeart files definitive proxy statement for acquisition of MedQuest

• Angiotech Pharmaceuticals, Inc. (Vancouver) corporate partner Boston Scientific Corporation announced that it has completed enrollment in the transitional phase of the world's largest drug-eluting stent registry. The OLYMPIA registry plans to enroll more than 30,000 patients at more than 600 centers in the United States, Europe and other international locations…….
• Isotechnika Inc. (Edmonton) announced that it has entered into an agreement for a $15,750,000 million bought deal financing with a syndicate of underwriters led by GMP Securities Ltd. And including Canaccord Capital Corp., National Bank Financial Inc., and TD Securities Inc. The proceeds from the offering will be used to fund the Company's Phase III trials for psoriasis and Phase IIb trial for transplantation and for general corporate purposes…….
• Hemosol Corp. (Toronto) announced that it has been notified by Nasdaq that the Company has regained compliance with Nasdaq National Market's minimum bid price requirement by achieving a closing bid price of at least US$1.00 per share for the 10 consecutive trading days ended on June 23, 2005…….
• Microbix Biosystems Inc. (Toronto) has extended its agreement with a major international vaccine producer, whereby the two companies will continue to collaborate in evaluating Microbix' proprietary technology designed to significantly boost the production yield of flu vaccine. The initial evaluation period was to expire June 30, 2005. Microbix' partner has now been granted an additional 90-day period to continue testing the technology……
• Inex Pharmaceuticals Corporation (Vancouver) announced extensive management changes and a restructuring to conserve cash and to facilitate a new strategic path to advance its lead anticancer drug Marqibo(TM), its other Targeted Chemotherapy cancer products and its promising early-stage Targeted Immunotherapy pipeline. Timothy M. Ruane has been appointed President and Chief Operating Officer (COO), effective immediately……
• Adherex Technologies Inc. (Ottawa), a biopharmaceutical company with a portfolio of oncology products under development, announced that it intends to complete a private placement offering of units for up to US$9 million in gross proceeds, each unit consisting of one common share and 0.30 of a common share purchase warrant. The offering is expected to close on or about July 15, 2005 subject to the completion of a pending licensing agreement and required board and regulatory approvals………
• TSO3 Inc. (Quebec City) announces that it has accepted an offer from Canaccord Capital Corporation on behalf of a syndicate of underwriters pursuant to which the Underwriters have agreed to purchase 3,750,000 units on a firm underwritten private placement basis, at a price of Cdn $2 per Unit for gross proceeds to TSO3 of Cdn $7.5 million…….
• Cedara Software Corp.(Toronto), a Merge Healthcare company and a leading independent developer of medical software technologies for the global healthcare market, today announced an exclusive relationship with Molecular Therapeutics of Ann Arbor, Michigan, in which Cedara will market and sell products based on new ground-breaking techniques in cancer assessment. Using a novel imaging process known as functional diffusion mapping, this technology will be integrated into software solutions for early detection of treatment response in cancer care.

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