Clinical Trials & Patents

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(Vancouver, BC) has received Health Canada approval to commence the first pediatric study of FluINsure™, the company’s intranasally delivered flu vaccine. The Phase II blinded, randomized, placebo-controlled study will enrol 160 healthy children ranging in ages from three to 12 years, and will evaluate one-dose and two-dose vaccine regimens.

Calgary, Alta.-based Oncolytics Biotech Inc. has been granted a patent that covers the use of a reovirus for the manufacturing of medications to treat Ras-medicated neoplasia, as well as methods of treating various cancers. The company’s lead candidate, Reolysin®, is a proprietary formulation of the human reovirus that has been shown to selectively kill cancer cells.

The Institutional Review Board at the Scott and White Memorial Hospital and Clinic (Temple, TX) has given Protox Therapeutics Inc. (Vancouver, BC) approval to conduct a Phase I clinical trial of PRX302 for the treatment of localized, recurrent prostate cancer. The study is designed to evaluate the drug’s safety and tolerability when administered through local injections into the prostate.

ART Advanced Research Technologies Inc. (ART) (St. Laurent, QC) and the Cedars Breast Clinic of the McGill University Health Centre (Montreal, QC) have launched a pivotal North American study of SoftScan®, ART’s optical breast imaging system. SoftScan is a non-invasive time-domain system that complements existing mammogram technology, characterizing benign and malignant breast tumours. The study will involve between 600 and 950 women, aged 25 to 60 and older, and will determine SoftScan’s clinical safety. ART plans to submit the study results to both Health Canada and the U.S. Food and Drug Administration to support the device’s pre-market approval.

Biogen Idec Inc. (Cambridge, MA) has initiated the Global Adherence Project (GAP), the largest multi-national study evaluating patient adherence to long-term multiple sclerosis (MS) treatments. The study is being run in collaboration with patients and physicians in 24 countries, including Canada, and aims to evaluate 1,800 patients with relapsing remitting MS in real-world settings who are taking one of the following medications: Avonex®, Betaseron®, Copaxone® or Rebif®. In examining patient adherence to these treatment plans, GAP will take into account such issues as social and economic influences, physician and other health-care delivery issues, disease conditions and individual patient dynamics.