www.bioscienceworld.ca Laboratory Focus
January 2012
PHARMA NOTES Bioniche Life Sciences Inc. (Belleville, ON) has entered into two distribution agreements to expand its product offerings in North America. The first agreement is with MedTrade Products Limited, a UK-based company. The agreement provides a number of equine and companion animal health products based on MedTrade’s CeloxTM technology for exclusive distribution by Bioniche in Canada. The CeloxTM technology uses chitosan, a natural polysaccharide, as a medical device in the animal health industry. The CeloxTM product line includes gauzes and granules that are utilized in wound healing. When mixed with blood, CeloxTM forms a gel-like clot in less than one minute, independent of the body’s normal clotting processes. The second agreement is with Mueller Medical International LLC, a U.S.-based company. The agreement provides an equine product – Equine Gastrafate® - for exclusive distribution in Canada and the U.S. by Bioniche. Equine Gastrafate® is a patented saccharide composition that is used to expedite management of gastrointestinal syndromes characterized by nausea, vomiting, diarrhea, colic and mucosal erosions. This product is often used by equine veterinarians who suspect ulcer colic in horses.
lieved to develop as a result of dysfunction in the protective epithelial layer lining the bladder.
Trillium Therapeutics Inc. (Toronto, ON), a privately-held biopharmaceutical company developing proprietary and innovative biologic therapies begin a Phase 1 clinical trial of its experimental drug, TTI-1612, in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). The company has recently received a No Objection Letter to its Clinical Trial Application from Health Canada’s Biologics and Genetic Therapies Directorate. The single ascending dose trial will be conducted at multiple sites across southern Ontario. IC/BPS, also known as Painful Bladder Syndrome, is a chronic, debilitating and poorly treated bladder disease affecting millions of people. The disease is be-
Xenon (Vancouver, BC) announces a strategic al-
Oncolytics Biotech Inc. (Calgary, AB) has released interim data from its Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer (REO 017) indicating that the clinical study has successfully reached its primary endpoint, and that the drug combination is active. To date, eight patients of 13 evaluable patients in the study had stable disease (SD) for 12 weeks or longer, for a clinical benefit rate (complete response (CR) + partial response (PR) + SD) of 62 per cent. An additional patient had an unconfirmed PR of less than six weeks. The study is using a one sample, two-stage design. In the first stage, 17 patients were to be enrolled, and best response noted. If less than three responses (defined as CR or PR or SD for 12 weeks or more) were observed, the study would have concluded that the combination was inactive and been terminated. If three or more responses were observed among the 17 patents, the study would enroll an additional 16 patients for a total of 33 evaluable patients.
liance with Genentech, a member of the Roche Group, to discover and develop compounds and companion diagnostics for the potential treatment of pain. Under the terms of the agreement, Genentech has an exclusive license to compounds and a non-exclusive license to diagnostics from Xenon for development and commercialization of products. Xenon will receive an undisclosed upfront payment, research funding and is eligible to receive research, development and commercialization milestone payments, totaling up to $646 million for multiple products and indications. In addition, Xenon will receive royalties on sales of products resulting from the collaboration. Aeterna Zentaris Inc. (Québec, QC) announces that the U.S. Food and Drug Administration (FDA) has granted Jose M. Garcia, MD, PhD an Investigational New Drug (IND) approval for the initiation of a Phase 2A trial to assess the safety and efficacy of repeated doses of the company’s ghrelin agonist, AEZS-130 (macimorelin), in patients with cancer cachexia. The study is a double-blind, randomized, placebo-controlled Phase 2A trial to test the effects of different doses of the ghrelin agonist, AEZS-130, in 18 to 26 patients with cancercachexia. The study will be conducted under a cooperative research and develop-
ment agreement (CRADA) with the Michael I. DeBakey Veterans Administration Medical Center which will be funding the study. AEZS-130 will be provided by Aeterna Zentaris. Allon Therapeutics Inc. (Vancouver, BC) has been granted a U.S. patent covering the use of Allon’s drug candidates, including its lead product davunetide, and other pipeline products for the treatment of laserinduced retinal damage. This new patent strengthens Allon’s intellectual property estate, which includes 15 patent families, 60 issued patents and over 30 pending applications worldwide. This patent relates to findings recently published in Acta Ophthalmologica which reported that davunetide has neuroprotective effects in an animal model of retinal laser injury. The results suggest the potential of davunetide as a treatment for retinal damage following retinal laser photocoagulation or other types of ophthalmic laser surgeries. Helix BioPharma Corp. (Toronto, ON) announces that the “clinical hold” on its investigational new drug application for its Topical Interferon Alpha-2b, Phase 2/3, low-grade cervical lesion efficacy trial has been removed by the U.S. Food and Drug Administration (FDA). The proposed Phase 2/3 trial is planned to be a
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randomized, double-blind, vehicle-controlled study in patients with cervical intraepithelial neoplasia grade 1 or 2 lesions (CIN 1 or CIN 2 respectively). The intended sample size is 492 female subjects to be randomized in a 2:1 ratio of active to control. Eligible women will be premenopausal subjects aged 18 - 55 years at screening, with histologicallyconfirmed CIN 1 or CIN 2 on colposcopic directed biopsy at screening and high risk human papillomavirus (HPV) infection upon the Hybrid Capture® 2 HPV-DNA test. The proposed primary study endpoint will be the resolution of CIN 1 or CIN 2 at month 12, determined by colposcopic directed cervical biopsy together with Pap smear cytology free of ASC-H (atypical squamous cells that cannot exclude high-grade squamous status), AGUS (atypical glandular cells of undetermined significance), LSIL (low-grade squamous intraepithelial lesions), HSIL (high-grade intraepithelial lesions), and adenocarcinoma in situ (AIS) or adenocarcinoma. The study is designed with a 12-month overall duration per patient, including treatment and follow-up. Helix plans that the results of its U.S. Phase 2/3 trial and the results of its European Phase 3 trial, if successful, will be submitted together in order to seek U.S. and European marketing authorizations for the product for this indication.
