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Laboratory Focus March 2011
Pharma Notes Cytochroma (Markham, ON) announces the initiation of a repeat-dose safety and efficacy study of CTAP101 capsules in patients with vitamin D insufficiency, secondary hyperparathyroidism (SHPT) and stage 3 chronic kidney disease (CKD). The newly initiated trial is a randomized, double-blind, placebo controlled, multisite study designed to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics and tolerability of CTAP101 capsules, administered at various daily doses, in approximately 60 patients. The endpoints in this study will include vitamin D status, adverse events, physical and clinical laboratory assessments, and changes in serum calcium, phosphorus and intact parathyroid hormone (PTH). Endo Pharmaceuticals (Newark, DE) and Bioniche Life Sciences Inc. (Belleville, ON) announce the enrollment of the first patient in the second Phase 3 clinical trial of Urocidin™. The trial is a randomized, active-controlled, open-label, multi-center study with a blinded endpoint assessment designed to compare UrocidinTM with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle invasive bladder cancer. It is estimated that 450 patients will be enrolled for this new trial at approximately 120 clinical sites worldwide. Stem Cell Therapeutics Corp. (Calgary, AB) has been granted a patent by the U.S. Patent and Trademark Office -U.S. Patent 7,884,072- entitled, “Prolactin induced increase in neural stem cell number.” The claims contained within this issued patent cover methods of using an effective amount of prolactin to increase stem cell numbers in mammals suspected of having neurological diseases. Helix BioPharma Corp. (Aurora, ON) has received approval for its investigational new drug (“IND”) application from the United
States Food and Drug Administration to perform its planned U.S. Phase I clinical safety and tolerability study of its lung cancer drug candidate L-DOS47. L-DOS47 is the Company’s first therapeutic immunoconjugate drug candidate under development based upon its novel DOS47 platform technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer. The FDA has completed its review of the IND and concluded that it is acceptable for Helix to proceed with the study, contingent on Helix providing an amended version of the clinical protocol beforehand, reflecting several minor changes that FDA stipulated during the course of the IND review. The company will now proceed with its remaining pre-study logistical preparations, including preparation and filing with the FDA of the required clinical protocol amendment, with a view to commencing clinical site initiation and patient recruitment activities late spring to early summer of this year. Dalton Pharma Services, (Toronto, ON) a privately
owned Canadian pharmaceutical services provider to leading pharmaceutical companies, has entered into a Manufacturing Services Agreement with Oncovir Inc., a specialty pharma company based in Washington DC, dedicated to the development of nucleic-acidbased clinical therapies for cancer, infectious, immune, and degenerative disorders. Dalton Pharma Services will provide API manufacturing and aseptic fill/finish services under cGMP, for Oncovir’s collaboration with the Cancer Vaccine Acceleration Fund (CVAF), a joint initiative between the Cancer Research Institute (CRI) and the Ludwig Institute for Cancer Research (LICR). CVAF has completed a new investment agreement with Oncovir, Inc., to enable the production of Oncovir’s immune activator Hiltonol®. Warnex Inc. (Laval, QC) announces that its Warnex Medical Laboratories division will serve as a central laboratory across Canada for Genzyme Canada Inc.’s (Ottawa, ON) Lysosomal storage disorders testing program. This program will assist physicians in diagnosing Fabry (male), Gaucher, Pompe and Mucopolysaccharidosis Type I (MPS I) diseases. Medwell Capital Corp. (Edmonton, AB) announces that it has committed to
invest up to $2,000,000 in Mimetogen Pharmaceuticals Inc. (Montréal, QC), a privately-held, clinical-stage company developing a treatment for dry eye disease. Medwell Capital participated in a Series B equity financing with existing Mimetogen investors, iNovia Capital, MSBi Valorisation and VIMAC Milestone Medica. As part of the financing, Nitin Kaushal, executive vice president of Medwell will join the Mimetogen Board of directors. Medwell Capital will also assist Mimetogen and the current investors with advisory services in potential partnering and financing efforts. Mimetogen’s lead drug candidate for the treatment of dry eye disease, MIM-D3, is a small molecule mimetic of nerve growth factor (NGF). NGF is a naturally occurring protein in the eyes that is responsible for the maintenance of corneal nerves and epithelium, mucin and tear production. Isotechnika Pharma Inc. (Edmonton, AB) announces that Lux Biosciences, Inc. (Jersey City, NJ) has commenced its Phase 3 trial using voclosporin for the treatment of non-infectious uveitis, a leading cause of vision loss and long-term disability. The study is a six-month randomized trial of voclosporin versus placebo in patients with active non-infectious intermediate,
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posterior, or pan-uveitis. This Phase 3 trial will involve 150 patients in North America and Europe. Lux is conducting this additional Phase 3 trial as outlined in the Complete Response Letter received in August, 2010, from the FDA. In 2006, Isotechnika granted Lux worldwide rights to develop and commercialize voclosporin for ophthalmic diseases. In return, Isotechnika will receive development milestones payments, as well as royalties on net sales. Voclosporin (branded as Luveniq™ by Lux) was accepted for review by the European Medicines Agency (EMA) in March 2010. The product has received Orphan Drug designation in both Europe and the U.S. for the treatment of non-infectious uveitis. Canadian specialty pharmaceutical company Paladin Labs Inc. (St. Laurent, QC), announces that Health Canada has approved Abstral®. Abstral® is a novel, rapidly-disintegrating, sublingual (under the tongue) formulation of fentanyl, a well-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for chronic pain. Paladin obtained the Canadian rights from ProStrakan Group plc in December 2008.
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