Pharma Notes

Norgen Biotek Corp. (Thorold, ON), a biotechnology company focused on innovations for nucleic acid and protein preservation and purification from all type of specimens for research and molecular diagnostic applications, announces successful accreditation to ISO 15189:2007 by the Standards Council of Canada (SCC). Norgen’s scope of accreditation for ISO 15189 will allow the company to provide molecular diagnostic testing for research purposes and clinical trials. Moreover, this ISO certification will allow Norgen to obtain regulatory approval for its various in vitro molecular diagnostic kits which are currently marketed for research use.

Spectral Diagnostics Inc.

(Toronto, ON) announces that it is expanding its U.S. Phase 3 EUPHRATES trial to Canadian clinical trial sites. The EUPHRATES trial is evaluating Spectral’s theranostic product candidate for the treatment of patients with severe sepsis and septic shock. In August, the company received approval from the U.S. FDA to increase the total number of clinical sites in its EUPHRATES trial from 15, to a total of 30, including international sites. Consultation with Health Canada and interested Canadian investigators has led to the decision to expand the trial into Canada.

YM BioSciences Inc. (Mississauga, ON) has enrolled the first patients in its multi-center Phase 2 trial of CYT387 administered twice-daily (BID) for the treatment of myelofibrosis. The trial will further evaluate the safety and tolerability of YM’s JAK1/JAK2 inhibitor, as well as its efficacy in reducing spleen size, improving constitutional symptoms and reducing transfusion dependence in patients with myelofibrosis. Six leading academic centres in the U.S. and Canada will recruit approximately 60 patients in two phases: Part 1, a dose-escalation study enrolling successive patient cohorts dosed starting at 200mg BID, escalating at 50mg BID per cohort; and Part 2, a dose-confirmation study evaluating patients at or below the maximum tolerated dose determined in Part 1. Patients in this trial will be evaluated for six 28-day cycles. In the BID trial, spleen size will be evaluated both by palpation and by magnetic resonance imaging (MRI) for all patients enrolled. Constitutional symptoms will be assessed using the Myelofibrosis Symptom Assessment Form (MFSAF). Transfusion histories will be collected for the six-month period prior to enrollment and transfusion independence will be based on both eight-week and 12-week criteria. The effect of CYT387 on plasma levels of inflammatory, fibrogenic and angiogenic cytokines, and on bone marrow and peripheral blood cytogenetics will also be assessed.

Cipher Pharmaceuticals Inc.

(Mississauga, ON) announces that Health Canada has approved CIPTRAMADOL ER, the company’s extended-release tramadol product, for the treatment of moderate to moderately severe chronic pain in adults. Cipher is currently preparing to commercialize the product, which includes finalizing sales and marketing plans and manufacturing requirements. The company expects to launch the product in 2012 under the name Durela™. In addition, Cipher is on track to launch its extended-release tramadol product in the U.S. market in late Q3 2011 with its marketing partner, Vertical Pharmaceuticals, Inc. Cipher also announces that it has entered into a distribution and supply agreement with Medical Futures Inc., a Canadian-based pharmaceutical company, under which Cipher has granted Medical Futures the exclusive right to market, sell and distribute Durela™ in Canada. Under the terms of the agreement with Medical Futures, Cipher will receive an upfront payment of CAD$300,000. Cipher is also eligible to receive future payments contingent upon the achievement of cumulative net sales milestones. In addition, Cipher will receive a double-digit royalty on net sales Cipher is responsible for product supply and manufacturing, which will be fulfilled by its partner, Galephar Pharmaceutical Research.

Canadian specialty pharmaceutical company Paladin Labs Inc. (St. Laurent, QC) has completed its previously announced acquisition of all of the outstanding common shares of Labopharm Inc. “The acquisition of Labopharm will add to our top line, through the addition of established international revenue streams, and will provide us the opportunity to build upon our existing operational capabilities. Moreover, Labopharm’s worldwide partnerships provide us with an exciting opportunity to continue cultivating important relationships internationally,” stated Mark Beaudet, interim president & CEO of Paladin Labs Inc.

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colorectal cancer linked to bacteria

Rob Holt. Photo: SFU Public Affairs and Media Relations Two new studies, one of them involving Simon Fraser University researchers, have uncovered the first link between human colorectal cancer and a specific microorganism.

The studies, just published online in the journal Genome Research, found the bacterium Fusobacterium hundreds of times more prevalent in tumours than normal tissue in 99 colorectal cancer patients. Colon cancer ranks as the second leading cause of cancer deaths.

Rob Holt, a SFU associate professor of molecular biology and biochemistry, B.C. Cancer Agency scientist and a senior author of one of the reports, said: “We were surprised by this result. Although Fusobacterium is a known infectious agent, it is rarely in the contents of a normal gut and until now hasn’t been associated with cancer.”

Holt and Matthew Meyerson (senior author of the other study and a pathologist with the Dana-Farber Cancer Institute in Boston) noted it has yet to be proven whether Fusobacterium infection causes or precedes colorectal tumours.

“Our future directions are to further investigate the possibility that Fusobacterium could be a direct cause of colon cancer and if so by what mechanism,” Holt said. “We will be also be applying the same methodology to look for correlations between infectious agents in other types of cancer. If Fusobacterium is proven to cause colorectal cancer, then targeting it with antibiotics or vaccines may provide a new approach to colon cancer treatment or prevention.”

While Holt and Meyerson were surprised by their independent studies’ results , they observed several previously known factors to support them.

“Gastric cancers have been previously linked to inflammation caused by the microorganism H. pylori. It’s well established now that patients with irritable bowel disease have higher rates of colorectal cancer. And about 15 per cent of cancers globally are caused by known infectious agents,” Holt said. “So it is possible that some of the many species of microbes found in the gut could be associated with colorectal cancers.”

Some other cancers known to be caused by viruses or bacteria are: cervical cancer (Human Papilloma virus) and liver cancer (Hepatitis B and C virus).

Richard Moore, an SFU adjunct professor in the Faculty of Health Sciences and a B.C. Cancer Agency researcher, and Mauro Castellarin, a SFU molecular biology and biochemistry doctoral student, worked with Holt on this study.