Pharmaceuticals & Biotherapeutics

Prometic reaches understanding for commercialization

ProMetic Life Sciences Inc. (Montréal) announced that it has reached an understanding with a fully integrated, U.S.-based, biotechnology company with respect to the development and global commercialization of several biopharmaceutical products in ProMetic's Protein Technology Division. In addition to licensing, development and milestone fees as well as on-going royalties on sales of products, the definitive agreements would provide for an initial strategic investment in ProMetic of $7 million at a share price of $0.47. This transaction is anticipated to provide a significant funding commitment towards the development and commercialization of the products, which would contribute to ProMetic's revenue growth as early as 2008. The definitive agreements would also provide for possible additional investments in ProMetic, which may be triggered by either the biotechnology company or ProMetic, upon fulfillment of certain predetermined conditions. Further, the definitive agreements would provide the biotechnology company to have a right to representation on ProMetic's board of directors.

Argos Therapeutics and Université de Montréal Present Novel Method

Argos Therapeutics (Durham, NC) and Université de Montréal (Montréal) announced the presentation of new information on Argos' process for developing dendritic cell-based immunotherapies for HIV. Results from the study demonstrated that loading monocyte-derived dendritic cells with combinations of HIV antigen RNA stimulates the expansion of HIV-specific T cells, which attack and kill HIV-infected cells. Argos' immunotherapies are generated by the Company's Arcelis™ technology, which is a platform for creating autologous, RNA-loaded dendritic cell-based therapies perfectly matched to each patient's unique virus.

Lorus Toxicology Program Supports Novel Route of Administration

Lorus Therapeutics Inc. (Toronto), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, announced the successful completion of GLP toxicology studies to explore a novel route of administration for its clinical-stage anticancer drug, LOR-2040. Two studies were conducted to assess toxicity of LOR-2040 when administered by intravesical (direct) administration into the bladder. In both studies, no evidence of toxicity was seen following single or repeated doses of LOR-2040 given with this method of administration. Toxicity was evaluated based on a wide range of observations including detailed examination of urinary tract tissues. The intravesical toxicology studies are the first assessment of local tissue toxicity of this drug. LOR-2040 has previously demonstrated low toxicity when administered intravenously, which is the current route of administration for this drug in clinical trials.

Mucous breakthrough in mice holds promise for cystic fibrosis

Dr. Richard Rozmahel, from London, Canada scientist studying cystic fibrosis (CF) has successfully corrected the defect which causes the overproduction of intestinal mucous in mice. He is a scientist with the Lawson Health Research Institute, affiliated with The University of Western Ontario, has clear implications to understanding and treating this facet of the disease in humans. CF is a fatal, genetic disease characterized by an overproduction of mucous in the lungs and digestive system. Rozmahel and his colleagues are identifying secondary genes that could contribute to CF, and measuring their impact on the disease. More specifically, they are investigating the potential of a gene found in mice, mCLCA3, which is similar to one in humans that exhibits abnormal levels in CF. The mCLCA3 gene is expressed by cells that produce and secrete mucous. The researchers discovered that mCLCA3 plays an important role in the property of mucous, thereby allowing it to be cleared rather than result in the blockages that underlie CF. By correcting the abnormal levels of mCLCA3 in CF mice they were able to overcome the mucous lesions. Whereas CF mice normally do not survive more than 4 weeks as a consequence of the mucous disease, the animals where mCLCA3 levels were corrected could live a normal lifespan.

Clinical Trials

Valens Pharma announces next steps

Valens Pharma Ltd. (Edmonton) announced that the Company has suspended work on its DCA i.v program, a proprietary intravenous formulation of dichloroacetate pending further review by its Scientific Advisory Board. Based on the analysis of the voluntary Phase II "Mini-Metrxics" clinical trial by the Company's Scientific Advisory Board to date, it is clear that Valens does not have sufficient evidence to quickly move into its planned Phase III METRxICS Trial as had been anticipated. As previously announced, while data from the Phase II trial met certain biochemical endpoints, the anticipated clinical signals of a reduction in time spent in the intensive care unit (ICU), a reduction in ventilator times and a reduction in hospital times were not present. While there were no deaths during the actual trial in this high risk geriatric population, there were more adverse events in the group that received DCA compared to the control group. Requests for further information may be directed to the Company. www.valenspharma.com

BioMS completes patient recruitment in phase III US multiple sclerosis trial

BioMS Medical Corp. (Edmonton), a leading developer in the treatment of multiple sclerosis (MS), announced that it has completed patient recruitment in its phase III clinical trial of MBP8298 (dirucotide) for the treatment of secondary progressive MS (SPMS). The trial, named MAESTRO-03, includes approximately 510 patients, and is being conducted at 68 trial sites in the U.S. www.biomsmedical.com

YM BioSciences announces preliminary results

YM BioSciences Inc. (Mississauga), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, announced preliminary results obtained from its open-label, Phase II study (YMB1000-015) of nimotuzumab in patients with irinotecan-refractory, metastatic colorectal cancer (mCRC). The data are based on 58 evaluable patients of the 61 enrolled in the trial. The trial was conducted at 10 centres across Canada and consisted of treatment with 400 mg of nimotuzumab weekly plus irinotecan in patients refractory to irinotecan alone, with patients remaining on nimotuzumab until disease progression. "These preliminary data are released upon our being advised that the trial has now reached the point at which more than 50 percent of the patients have died. The overall survival (OS) and disease control rate (DCR) for patients receiving nimotuzumab compare well with published results in similar patient populations treated with cetuximab, a currently marketed EGFR monoclonal antibody. Nimotuzumab also continues to display a safety profile unequalled in its class. This low incidence of toxicity with nimotuzumab may be related to differences reported in its interaction with EGF receptors compared with other EGFR targeting antibodies," said Dr. Paul Keane, Director of Medical Affairs for YM BioSciences. www.ymbiosciences.com

Aegera Initiates a Fifth Phase 1 and 2 Clinical Trial for AEG35156

Aegera Therapeutics Inc. (Montréal) announced the dosing of the first patient in a fifth phase 1 and 2 clinical oncology study of AEG35156, a second generation antisense therapeutic targeting XIAP, a key member of the Inhibitor of Apoptosis protein family. The primary objective of this study is to determine the recommended dose of AEG35156 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and follicular lymphoma (FL), and to determine the safety profile and response rate to AEG35156 in these patient populations. www.aegera.com

MethylGene and Celgene Announce Precautionary Suspension

MethylGene Inc. (Montréal) and Celgene Corporation (Summit NJ) announced that, at the recommendation of a standing internal safety committee, the companies are temporarily suspending enrollment of new patients into clinical trials evaluating MGCD0103. This voluntary precaution is being taken due to the observation of pericarditis or pericardial effusion in 19 patients out of approximately 400 patients treated to date. Approximately half of the reported cases have been deemed by investigators as unlikely to be drug related. It is not yet determined whether the potential signal is drug related due to confounding factors in these complex and late-stage cancer patients. Because the events tend to occur during the first cycle of treatment, patients currently enrolled in MGCD0103 clinical trials who have no signs or symptoms of the events are not affected by this temporary action and may continue in their respective studies. www.methylgene.com www.celgene.com

Polydex Announces Final Report From Phase III Study

Polydex Pharmaceuticals Limited (Toronto) reports that the final analysis from the Phase III clinical trial of Ushercell, a cellulose sulphate gel developed by Polydex primarily for use by women as a topical contraceptive, was published in the New England Journal of Medicine on July 31, 2008. The Phase III clinical trials were conducted to test Ushercell's efficacy in prevention of HIV and other sexually transmitted infections. The trials were halted in January 2007 when an independent review of the interim data revealed a higher than expected incidence of HIV in participants at some trial sites. www.Polydex.com

Industry Briefs

Cipher Pharmaceuticals Inc. (Mississauga) announced that it has entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Limited, under which Cipher has granted RPI the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States, its territories and possessions. www.cipherpharma.com

MedX Health Corp. (Mississauga) announced the closing of a non-brokered private placement of 4 300 000 common shares at a price of $0.25, for gross proceeds of CAD$1 075 000. www.medxhealth.com

DiagnoCure Inc. (Quebec City), a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced that four prominent colorectal cancer key opinion leaders have agreed to serve on the Strategic Advisory Board of its wholly owned subsidiary, DiagnoCure Oncology Laboratories. www.diagnocure.com

NIR Diagnostics Inc. (Campbellville), an innovator in the development of handheld healthcare diagnostic devices, announced that it has completed a loan financing. On July 31, 2008, the Company issued a promissory note in the amount of US$250 000 to Clear Light Ventures, Inc. ("Clear Light"). The Company will use the proceeds of the Loan for continuing research and working capital requirements. www.nirdiagnostics.com

Cytochroma (Markham) announced the closing of a CDN $45 million Series C financing. The financing was led by a new investor, Mitsubishi Tanabe Pharma Corporation, and supported by a number of existing investors including Vengrowth Advanced Life Sciences Fund Inc., Caisse de Dépôt et Placement du Québec, Novo A/S, Canadian Medical Discoveries Fund Inc., T(2)C(2)/Bio 2000 Limited Partnership, GrowthWorks Canadian Fund Ltd., BDC Capital Inc., and VentureLink Brighter Future Fund Inc. www.cytochroma.com

MedMira Inc., (Halifax), a developer and marketer of rapid diagnostics, announced that it has expanded its global distribution network into Southeast Asia, where the Company's MiraWell(R) Rapid HIV Test (MiraWell HIV) will soon be available to healthcare providers and their patients. www.medmira.com

Sequenom, Inc. (San Diego CA), a leading provider of genetic analysis solutions, and Génome Québec announced that the McGill University and Génome Québec Innovation Centre has become the first Center of Excellence certified by Sequenom for genotyping technology. The Center of Excellence certification is a collaborative partner relationship aimed at ensuring high-quality data available from genotyping application using the Sequenom MassARRAY® system performed at Génome Québec.

Lorus Therapeutics Inc. (Toronto), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, announced the allowance of a new patent from the United States Patent and Trademark Office for its clinical-stage anticancer drug LOR-2040. www.lorusthera.com