Ottawa, ON – January 8, 2004 – The following life sciences news briefs were published this week by Industry Canada.
1) Pharmaceuticals Update
Phase I clinical trial for Inex/GlaxoSmithKline drug
Inex Pharmaceuticals (Vancouver) announced that the commencement of a phase I human clinical trial for the GlaxoSmithKline (GSK) anticancer drug topotecan HCl encapsulated in Inex’s transmembrane carrier system (TCS) drug delivery technology has been delayed and is scheduled to occur in the third quarter of 2004. The previous guidance was for the trial to start in the first quarter of 2004. David Main, president and CEO of Inex, said the original schedule was dependent on GSK producing sufficient quantities of the drug before the end of the year. Although the manufacturing of this clinical trial material has been delayed, GSK says it remains committed to the topotecan project and is working hard to reschedule and complete the manufacturing and release of clinical trial material in the first quarter of 2004 in order to start the phase I trial during the third quarter of 2004. Encapsulating anticancer drugs inside Inex’s proprietary TCS drug delivery technology may provide prolonged blood circulation, increased accumulation in tumors and extended drug release of the encapsulated drug at the cancer site.
Lorus results of synthesis and characterization of clotrimazole analogues
Scientists at Lorus Therapeutics (Toronto) have published the results of experimental studies aimed at synthesizing and optimizing analogues of clotrimazole (CLT), an anti-fungal drug that has demonstrated anticancer activity. These studies were part of a larger project that characterized NC 381, a CLT derivative that was extensively studied as a lead drug candidate. While the class of compounds described in the article is significantly different from the one to which NC 381 belongs, they all form part of the CLT library of analogues, which provide an opportunity to further advance these analogues with the goal of developing novel anticancer therapeutics. The results appear in an article entitled, “Triaryl-Methane Derivatives as Antiproliferative Agents,” published in a peer reviewed December 6th electronic version of the journal Bioorganic and Medicinal Chemistry letters.
Theratechnologies completes enrollment for phase II trial
Theratechnologies (Montreal) announced that it has completed enrolment for its phase II clinical study in HIV-related lipodystrophy using ThGRF. HIV-related lipodystrophy is a metabolic syndrome that affects a large number of patients who are otherwise well controlled for HIV, and is characterized by abdominal adiposity (fat accumulation), increased cholesterol levels and glucose intolerance. The trial, which aims to assess the safety and efficacy of ThGRF in reducing abdominal adiposity, began in May 2003 and the results are expected at the end of the first quarter of 2004. HIV-related lipodystrophy patients are more prone to type II diabetes, and recent data have demonstrated that this metabolic syndrome is associated with increased cardiovascular complications. It also raises other medical concerns, including potential non-compliance to HIV medication, in addition to having a negative impact on quality of life. The company estimates that there are approximately 250,000 patients worldwide who are experiencing signs of HIV lipodystrophy. Currently, there is no approved drug or therapy for this medical condition.
2) Diagnostics and Therapeutics Update
ProMetic accelerates its plan to scale up manufacturing capacity
ProMetic Life Sciences (Montreal) announced it has filed a short form prospectus and entered into an agreement with Loewen, Ondaatje, McCutcheon to act as lead agent in connection with a proposed offering of subordinate voting shares in order to provide the company with the necessary resources to accelerate its commercial plan. The shares will be publicly offered in Canada under a short form prospectus. The transaction is subject to the receipt of all necessary regulatory and stock exchange approvals and closing is expected to occur on or about December 24, 2003. The net proceeds of the offering shall be used to increase the manufacturing capacity of the company’s subsidiaries, to accelerate the scale up and commercialization of the plasma purification business in partnership with the American Red Cross, for the development of a second pathogen removal and diagnostic technologies (PRDT) product, to fund ongoing research and development of the therapeutic product candidates and for working capital purposes.
SARS coronavirus part bird, part mammal: University of Toronto study
The study, published in the January issue of the Journal of Virology, sheds light on the SARS coronavirus, a deadly form of pneumonia caused by the same viral family as the common cold. By tracing its evolutionary history, researchers theorize that SARS is likely the result of a rare recombination of viruses from both mammalian and avian hosts. This, they believe, forms an entirely new virus unrecognizable to human immune systems. Understanding the evolution of SARS is a crucial step towards managing future viral outbreaks, according to the study’s co-author David Guttman, a professor of evolutionary genomics in the department of botany, University of Toronto. Identifying the specific evolutionary changes that enables this virus to spread into the human population should dramatically improve our understanding of why this particular virus is so virulent. “This will allow us to design more effective treatments and respond more effectively to future outbreaks,” says Guttman.
AEterna updates Neovastat’s clinical development plan
AEterna Laboratories (Quebec City) presented the company’s updated plan on the clinical development of Neovastat. This plan includes the continuation of the phase III trial in non-small cell lung cancer sponsored by the US National Cancer Institute (NCI) with which AEterna has just renewed the agreement for a period of two years. Also, for strategic considerations, AEterna ceases all activities related to renal cell carcinoma, resulting in a workforce reduction. These decisions are based upon management’s evaluation of the recommendations of an international committee of six oncology experts, combined with an extensive analysis of the development plan for AEterna’s 12-product portfolio, the competitive environment, as well as the time and investments that would be required to conduct an additional phase III study in kidney cancer. These actions are part of the company’s strategy aimed at reaching profitability for AEterna.
3) Medical Devices
Cedara and Alion join forces to develop life-saving technology
Cedara Software (Toronto), an independent developer of medical software technologies for the global healthcare market, has signed a development agreement with Alion Science and Technology to supply the US military with ultrasound guidance surgical technology that will reduce combat fatalities. Although initially targeted for military use, the new technology may ultimately be used in civilian emergency services around the world to prolong the survivability of patients with stroke, heart attack, and other traumatic injuries. Under the terms of the agreement, Cedara will provide its imaging software to integrate with portable ultrasound equipment. Cedara’s software will display 3D images of critical anatomy and provide essential guidance in performing life-saving surgery. This breakthrough medical software, as part of Alion’s solution, will enable an otherwise difficult procedure to be performed quickly and safely by a broad range of medically trained personnel. The introduction of this new technology is expected to dramatically improve soldiers’ survivability.
MedMira files data to support new application for the Reveal test
MedMira (Halifax) announced that it has successfully completed the clinical requirements set forth by the US Food and Drug Administration (FDA) for a new vers
ion of the Reveal Rapid HIV-1 antibody test. Completion of the clinical evaluation indicated 100% overall performance of the improved product. MedMira has recently submitted this data to the FDA to supplement its current pre-market approval for that product. In April 2003, MedMira received approval to market its Reveal rapid HIV-1 antibody test in the US. At the same time, the company had pursued an additional application for this product. The new version of the approved rapid HIV test includes an on-board procedural and reagent control line, which potentially eliminates the need for external controls, and enhancements to several components. These improvements will provide a more user friendly and cost-effective approach to rapid HIV testing.
Biotech in British Columbia
The biotechnology industry in British Columbia has seen a significant change in 2003. A year ago, the number of biotech financings was low. Many BC biotech companies were quietly concerned about their ability to weather this drought in financings, and how long it might last. In recent months BC, like the US, has seen an increase in financings. While there were only a few financings in late 2002 and early 2003 (Twinstand Therapeutics-$4m and Cardiome-$8m), the window started to open in late spring and early summer and a number of our local biotech companies successfully closed financings including Inex-$25m; QLT-US$173m; and Cardiome-$20m and more recently Oncogenex-US$11.5m; ID Biomedical-US$100m; and Angiotech-US$250m. NeuroMed just announced the successful closing of a US$32m round and Inflazyme has entered into a bought deal agreement to raise just over $15m.
5) Industry Update
YM BioSciences (Mississauga), a cancer drug development company with an advanced-stage portfolio, announced it has completed the sale of 10,895,658 special warrants for total proceeds of C$19,067,402 by way of a private placement to US and Canadian institutional investors.
ART Advanced Research Technologies (Montreal), a leading developer of bio-optical imaging technologies, is pleased to announce that it has acquired exclusive worldwide licensing rights to Dr Joseph Lakowicz’s extensive optical molecular imaging patent portfolio.
Vasogen (Mississauga), announced that it has been approved for listing on the Nasdaq National Market. Trading on the Nasdaq is expected to commence on December 17, 2003, under the symbol VSGN. Vasogen’s common shares will continue to trade on the Amex until that time.
Dimethaid International, a wholly owned subsidiary of pharmaceutical developer Dimethaid Research (Toronto), has been notified that arbitration initiated against the company by Provalis Healthcare has been decided. Under the decision, Dimethaid will pay Provalis the compensatory sum of approximately US$2.1 million, together with costs and interest of approximately US$632,000. A counterclaim by Dimethaid against Provalis was denied. The arbitrator’s decision is final and binding.
Micrologix Biotech, a developer of anti-infective drugs (Vancouver), has advanced MBI-2401 as the lead development candidate from its lipopeptide program. The compound selected is intended to be an intravenous product for the treatment of serious, hospital-acquired Gram-positive infections.
ProMetic Life Sciences (Montreal) announced that its wholly owned UK subsidiary, ProMetic BioSciences, has entered into an exclusive worldwide agreement with Mitra Medical Technology (Lund, Sweden) for the manufacture and supply of the key component of their new medical device Mitradep, developed for use in the area of cancer therapy and cancer diagnosis. This key component is to be manufactured by ProMetic at its production facilities on the Isle of Man, UK.
Andromed (Montreal) a high-tech innovative medical company, announced today that it no longer sells electronic stethoscopes to one of its distributors, Philips Medical Systems, following the intention of the latter to discontinue the distribution of Philips Electronic Stethoscope brand.
SYN X Pharma (Toronto) announced that it has been granted a United Kingdom patent, No 2380546 entitled, “Process for Differential Diagnosis of Alzheimer’s Dementia and Device Therefor”.
Theratechnologies (Montreal) announced that a first subject has been dosed in a phase I clinical study for ThPTH, its transdermal formulation of parathyroid hormone being developed in collaboration with ALZA of Mountain View, California for the treatment of osteoporosis.
Calgary Laboratory Services (Calgary) and Tm Bioscience (Toronto) announced their intention to collaborate on the development of a novel genetic test for the identification and characterization of Staphylococcus aureus, particularly methicillin-resistant Staphylococcus aureus in a hospital setting.
Procyon Biopharma (Montreal) announced that it has successfully completed the enrolment stage of its phase IIa study to evaluate the safety and tolerability of PCK3145, Procyon’s therapeutic drug indicated for hormone-refractory prostate cancer
Life Sciences News Briefs 2004 is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Paul Vaillancourt; Tel: 613-952-7700; E-mail: email@example.com).