Life Science News Briefs Vol. 6 no.34 - November 22, 2006

• Pharmaceuticals & Biotherapeutics Update
• Clinical Trials Update
• Medical Devices and Diagnostics Update
• Industry Briefs

Pharmaceuticals & Biotherapeutics Update

Cannasat Therapeutics and IntelGenx Enter into a Collaborative Agreement

Cannasat Therapeutics Inc. (Toronto) and IntelGenx Corp. announced a long-term collaborative agreement to co-develop novel cannabinoid-based products through a combination of Cannasat's and IntelGenx's proprietary drug delivery technologies. The collaboration will focus on the development and production of new formulations of cannabinoid pharmaceutical products, starting with Cannasat's lead product, CAT 310. Cannasat will leverage IntelGenx's significant experience in developing unique oral, sublingual, and transdermal formulations. IntelGenx's expertise will help address the challenges of achieving rapid onset, improving therapeutic efficacy, and minimizing central nervous system side effects with cannabinoids in treating disease indications such as neuropathic pain, movement disorders, and chronic pain. http://www.cannasat.com

Clinical Trials

TrialStat, NewLab Clinical Research and BioTheraGene

TrialStat Corporation (St. John’s), a clinical data management on demand company, created with NewLab Clinical Research Inc. and BioTheraGene Inc. the Newfoundland and Labrador Research Consortium (NLRC). The consortium's three founding companies will jointly offer comprehensive clinical trial consulting, operations and management services to pharmaceutical and biotechnology companies conducting trials in Newfoundland Labrador. Like Iceland and areas in Northern Quebec, Newfoundland Labrador offers biotechnology and pharmaceutical firms one of the world's most unique founder patient populations for recruitment and research. NewLab Clinical Research, one of Newfoundland Labrador's foremost clinical research organizations, and BioTheraGene, which has expertise in pre-clinical and clinical development of biologics, post-market safety assessment and risk management, will lead the delivery of NLRC's professional services and consulting while ClinicalAnalytics (CA) 4.0(TM), TrialStat's on demand EDC (electronic data capture) software, will form the backbone of the consortium's advanced data capture and trial management capabilities. http://www.trialstat.com

BioMS announces Hans-Peter Hartung as Coordinator for pivotal trial

BioMS Medical Corp (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced Professor Hans-Peter Hartung as National Coordinator in Germany for the ongoing pivotal phase II/III trial of its lead drug, MBP8298, a proprietary synthetic peptide for the treatment of multiple sclerosis. Professor Hartung is also a member of the Clinical Advisory Group for the international phase II/III trial. Professor Hartung is Professor and Chairman, Department of Neurology at Heinrich-Heine-Universitdt Dusseldorf in Germany. "Professor Hartung is world renowned in the area of multiple sclerosis and we are very pleased to have his support and involvement in our international pivotal phase III trial for MBP8298," said Kevin Giese, President and CEO of BioMS Medical. http://www.biomsmedical.com

Isotechnika Announces Initial Data from Phase IIb Kidney Transplant Trial

Isotechnika Inc. (Edmonton) announced results from initial data for its Phase IIb kidney transplant trial of the Company's lead immunosuppressive drug, ISA247. To date, 133 patients have been enrolled in the trial. Based on an early review of the unaudited data, the Company has observed a similar incidence of rejection episodes between the low (0.4 mg/kg twice daily) and mid (0.6 mg/kg twice daily) ISA247 dosing groups as in the tacrolimus control arm. To date, there have been no rejections in the high (0.8 mg/kg twice daily) ISA247 dose group. When all three of the ISA247 dosing groups are combined, there is an 8% rate of acute rejection in the ISA247 groups compared to a 14% rate in the tacrolimus group, which is being dosed according to clinical practice. As part of the trial, kidney function is being measured by Glomerular Filtration Rate (GFR) on an ongoing basis. Based on the data generated to date, very good kidney function has been observed in all of the ISA247 dosing groups. Within the first month post-transplant, kidney function showed improvement across all ISA247 dosing groups similar to that observed in the tacrolimus group. Additionally, there have been no clinically significant differences noted in cholesterol and triglycerides or other laboratory parameters examined to date in patients receiving ISA247. http://www.isotechnika.com

Helix completes Phase 2 clinical study with Topical Interferon Alpha-2B

Helix BioPharma Corp. (Aurora) announced completion of enrollment and treatment in its Phase 2 clinical study of Topical Interferon Alpha-2b in women with low-grade squamous intraepithelial lesions ("LSIL") that are positive for human papilloma virus ("HPV") infection. The study was designed to evaluate the safety and effectiveness of Topical Interferon Alpha-2b in patients with cytologically confirmed LSIL and polymerase chain reaction ("PCR") confirmed HPV. Patients received Topical Interferon Alpha-2b therapy applied intravaginally three times a week for a period of six weeks, followed by a six week follow-up period. The primary study endpoint is to determine the proportion of patients with resolution of their abnormal Pap smear during the twelve week study duration. Other study assessments include safety and tolerability, pre- and post-study histological examinations by way of colposcopy and qualitative assessment of HPV-positive status using PCR. In addition, the Company studied a second patient population that received no treatment whatsoever as a comparator to the treatment population. As planned, 40 patients were enrolled across the two patient groups, divided into 20 patients in each group. No serious adverse drug reactions were reported in the study. The Company is completing analytical work on patient samples collected over the duration of the patient testing and will be gathering and analyzing the final data. The Company expects to complete all data analyses and report the final integrated study findings during the first quarter of calendar 2007. http://www.helixbiopharma.com

Cytochroma initiates Phase II clinical trial for psoriasis

Cytochroma Inc. (Markham) has initiated the recruitment of patients with chronic plaque psoriasis for a Phase II clinical trial with CTA018 cream. CTA018 is a novel vitamin D analog with a dual mechanism of action designed to be both a strong activator of the vitamin D signaling pathway and a potent inhibitor of CYP24 activity (the enzyme responsible for the catabolism of vitamin D). CTA018 was previously studied in two Phase I clinical trials and demonstrated to be both well tolerated and efficacious in the treatment of patients with psoriasis. http://www.cytochroma.com

Medical Devices and Diagnostics Update

Angiotech submits application for European regulatory approval

Angiotech Pharmaceuticals, Inc. (Vancouver), a global specialty pharmaceutical and medical device company, announced that it has submitted an application for a CE Mark for its Vascular Wrap(TM) paclitaxel-eluting mesh / ePTFE vascular graft combination product on the strength of the results from its European first-in-man study. "This filing is an important milestone for Angiotech," said William Hunter, MD, President and CEO of Angiotech. "With the acquisition of the vascular graft product line from Edwards Lifesciences last year, as well as the acquisition this year of American Medical Instruments, we believe we are well positioned to capitalize on and economically benefit from this potentially category-defining product. http://www.angiotech.com

Industry Briefs

MIGENIX Inc. (Vancouver), has entered into an agreement with Canaccord Capital Corporation for the purchase, on a bought deal basis, of 16,750,000 Units of the Company at a price of $0.60 per Unit, for aggregate gross proceeds of $10,050,000. Each Unit consists of one common share and one-half of one common share purchase warrant. Each whole warrant entitles the holder to purchase one common share at a price of $0.80 for a period of 60 months from the closing date. http://www.migenix.com

ARIUS Research Inc. (Toronto) announced the appointment of Warren Whitehead as Chief Financial Officer. http://www.ariusresearch.com

GeneNews Limited (Toronto), formerly ChondroGene Limited, announced that Dr. Roman L. Zastawny has been appointed Vice President of Biomarker Development. In this role he will lead the product development effort at GeneNews with primary responsibility for moving the Company's first product, ColonSentry(TM), from R&D to commercialization. http://www.genenews.com

CryoCath Technologies (Montreal), the global leader in cryotherapy products to treat cardiovascular disease, has been named to Deloitte's prestigious Technology Fast 500 Program. This is a ranking of the fastest growing technology, media, telecommunications and life sciences companies by Deloitte & Touche USA LLP, one of the nation's leading professional services organizations. Rankings are based on the percentage revenue growth over five years from 2001-2005. CryoCath was ranked 69th overall on the list. http://www.cryocath.com

(Life Sciences News Briefs © 2005 is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Louise Leduc Tel: (613) 954-4715; E-mail: Leduc.Louise@ic.gc.ca).