Pharma Notes

Medicago Inc. (Québec City, QC) receives clearance from Health Canada to commence a Phase II human clinical trial with its H5N1 Avian Influenza vaccine (“H5N1 vaccine”). Enrolment of volunteers is now underway. The Phase II randomized, placebo controlled clinical trial will evaluate the safety and immunogenicity of different doses of its H5N1 vaccine. Specifically, the vaccine will be studied in approximately 255 healthy adults between the ages of 18 to 60 years. In the first part of the study healthy adults will receive an injection of either a placebo or the H5N1 vaccine at varying doses to determine the optimal dose. In the second part of the study, healthy adults will receive an injection of either a placebo or the H5N1 vaccine at the optimal dose. Interimresults of this study are expected in less than three months.

Cipher Pharmaceuti-

cals Inc. (Mississauga, ON) completes patient enrolment in its Phase III safety study of CIP-ISOTRETINOIN, the company’s novel, patented formulation of isotretinoin, which is used in the treatment of severe, nodular acne. The Phase III safety study is being conducted under a Special Protocol Assessment that was granted by the U.S. Food and Drug Administration (FDA). The study is a randomized, double-blinded trial comparing the safety profile of CIPISOTRETINOIN to an FDAapproved, commercially available isotretinoin product. A total of 931 patients were enrolled in the trial, of which 626 have completed treatment to date. “Following an estimated six-month treatment period, the last subject enrolled should complete treatment in April 2011. We expect to have top-line study results in early Q3 2011, which would be followed by an FDA submission in Q4 2011,” said Dr. Jason Gross, Cipher’s vice president of Scientific Affairs.

Oncolytics Biotech Inc.

(Calgary, AB) announces that interim data from a U.K. translational clinical trial (REO 013) investigating intravenous administration of REOLYSIN® in patients with metastatic colorectal cancer prior to surgical resection of liver metastases was presented at the International Symposium on Cytotoxic T-lymphocytes (CTL) and Immunostimulation being held in Pamplona, Spain. The presentation was given by principal investigator professor Alan Melcher of Leeds Institute of Molecular Medicine, University of Leeds, UK. The trial is an open-label, non-randomized, single centre study of REOLYSIN given intravenously to patients for five consecutive days in advance of their scheduled operations to remove colorectal cancer deposits metastatic to the liver. Patients were treated with intravenous REOLYSIN at 1x1010 TCID50, one to three weeks prior to planned surgery. After surgery, the tumour and surrounding liver tissue was assessed for viral status and anti-tumour effects.

OncoGenex Pharma-

ceuticals Inc. (Vancouver, BC) completes a public offering of 3,174,602 units at a price to the public of $15.75 per unit for an aggregate offering amount of $50 million, as previously announced on Oct. 18. The net proceeds to OncoGenex, after underwriting discounts and commissions and other offering expenses, from the sale of the units is approximately $46.7 million. The company intends to use the net proceeds from the offering primarily to advance its product pipeline, including its lead program, custirsen, and OGX-427, which is currently in clinical development as a treatment for prostate cancer and bladder cancer, as well as for general corporate purposes.

Labtronics Inc. (Guelph, ON) signs a partnership agreement with BioGenex Laboratories Inc to interface its i6000 and Xmatrx Automated Staining Systems to LIMS and LIS systems. BioGenex Laboratories Inc is a developer of sophisticated staining systems for clinical diagnostics and research laboratories. In recent years they have seen an increase in customer demand for advanced integration between their instruments and LIMS and LIS systems. In order to provide the best global solution to its customers, BioGenex has partnered with Labtronics Inc to provide LimsLink as the standard interfacing solution. LimsLink has been a standard in the industry for many years and has a proven track record for providing advanced interfaces between any instrument and any LIMS or LIS system. The latest version of LimsLink provides standard methods that simplify the implementation of solutions. It also provides back end database support that will provide customers with instrument analytics.

Trans-Hit Biomarkers

Inc. (Montréal, QC) enters into an alliance agreement with Caprion Proteomics Inc. Trans-Hit Biomarkers and Caprion will combine its expertise to deliver an integrated service approach, called ‘’Proteome-Hit’’ for accelerating clinical development and validation of novel protein biomarkers. By combining TransHit’s access to high-quality biospecimen collection with Caprio’ns mass spectrometry-based MRM assays for high-throughput, multiplexed quantitative measurement of proteins, ‘’Proteome-Hit’’ will allow rapid multiplexed measurement of protein biomarker candidates on large number of patient samples from high-quality biospecimen collections. Dr. Pascal Puchois, chief executive officer of Trans-Hit Biomarkers, stated ‘’Caprion’s mass spectrometry-based MRM services for rapid multiplexed measurement of candidate protein biomarkers, provide a cost and time-effective alternative to the development of immunoassays. This partnership with Caprion allows us to provide scientists with a solution to quickly measure new protein biomarkers on larges sets of samples, without having to develop immunoassays and questioning the quality of the samples and therefore help deliver stronger clinical proof of concept to their newly discovered protein biomarkers.’’

The Canadian Phar-

maceutical Distribution

Network (CPDN) (Toronto and Oakville, ON) joins GHX, enabling participating hospitals to gain greater visibility into their pharmaceutical purchasing. CPDN is a service provider to independent drug manufacturers comprising 19 of the leading pharmaceutical companies serving the Canadian hospital market. Approximately 80 per cent of Canadian hospitals that maintain accounts with pharmaceutical companies use the CPDN program to consolidate ordering and delivery of pharmaceutical products from independent pharmaceutical companies. Using the CPDN Web OMS browser-based ordering system, participating hospital pharmacies can place a single order to purchase products from multiple manufacturers, receive the products in a single shipment and make a single invoice payment.

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