Ottawa, ON – February 6, 2004 – The following life sciences news briefs were published by Industry Canada this week.
1) Pharmaceuticals Update
Labopharm reports results from US phase III studies for Tramadol
Labopharm (Laval) reported results from its two recently completed phase III clinical trials (MDT3-002 and MDT3-003) in the United States for its lead in-house product, a once-daily formulation of the analgesic tramadol. In trial MDT3-003, Labopharm’s once-daily formulation of tramadol achieved statistical significance for the three co-primary endpoints, which were reduction in pain, improvement in physical function, and patient’s global assessment of the product’s effectiveness. In trial MDT3-002, while once-daily tramadol demonstrated a similar improvement in pain relief, physical function and patient’s global assessment, due to an unusually high response to placebo, statistical significance was not demonstrated for all of the three co-primary endpoints. The two studies enrolled approximately 1,100 patients. Additionally, in both trials, Labopharm’s once-daily tramadol provided full 24-hour pain relief and exhibited an adverse events profile clinically superior to that of the immediate release formulation of tramadol as reported in the literature. These study results together with the results from Labopharm’s European phase III clinical trial for once-daily tramadol will form the basis of a new drug application (NDA) with the US Food and Drug Administration (FDA).
Apotex strengthens innovative drug research
The Apotex Group of Companies (Toronto), a developer of generic pharmaceuticals, has announced the reorganization of its innovative drug division into a new company called ApoPharma. The new company will be devoted to the development and discovery of new medicines. “Our plans are to draw upon the extensive general research infrastructure in the Apotex community to support the innovative research direction of ApoPharma as we bring needed therapeutic modalities to market,” said the newly appointed president, Dr Michael Spino. "We expect that this newest company in the Apotex family will further strengthen the sustained growth of the parent company as it generates sales of innovative products developed in Canada,” voiced Jack Kay, president of Apotex. Some of the key research and development projects of ApoPharma in clinical trials this year include iron chelators for treatments associated with iron overload; a treatment for difficult-to-heal wounds, such as diabetic foot ulcers by a patented process of delivering human fibroblasts to generate new skin in extensive wounds; and a novel treatment for intractable halitosis. There are no plans in place to go public with ApoPharma at this time.
Researchers create lung cancer “cluster bombs”
The butcher, the baker, and the candlestick maker may be more famous, but the pharmacist, the engineer, and the doctor may be onto something big. The latter group has combined resources and knowledge to create a novel way to deliver a new lung cancer treatment. The new system, which uses nanoparticle cluster bombs, has proven effective in treating cancerous lung cells in vitro (in a petri dish), it was reported in the International Journal of Pharmaceuticals. The research team from the University of Alberta will conduct in vivo tests (in live specimens) early this year, with plans for clinical trials to follow.
2) Diagnostics and Therapeutics Update
Adherex issued cancer diagnostics patent: new approach to cancer
Adherex Technologies (Ottawa), a biopharmaceutical company, announced it was issued a new US patent for methods of diagnosing and evaluating the status and progression of cancer. “This patent describes a number of new methods that may be useful in the detection of prostate, ovarian or breast cancer, as well as leukemia,” explains Dr Orest Blaschuk, chief scientist and a scientific founder of Adherex. “These methods are based on the discovery that some cancer cells may express new adhesion molecules on their surfaces as they become metastatic, thereby enabling their identification.” The patent provides the technological basis for “mapping” the cadherin profile on cancer cells. Profiling the cadherins could potentially be used to aid in the early diagnosis of cancer and to give guidance to doctors on which therapeutic approaches to use at different stages of the disease for each individual patient.
3) Medical Devices
Isotechnika – Diatest results published in diabetes care
Isotechnika (Edmonton) announced results from a study on the Diatest, a breath test developed to measure insulin resistance will be published in the current issue of Diabetes Care. The study performed by Drs Richard Z Lewanczuk, Breay W Paty and Ellen L Toth from the division of endocrinology, University of Alberta included a total of 26 subjects with varying degrees of insulin resistance. The subjects underwent both the Diatest and the hyperinsulinemic-euglycemic clamp, the gold standard method used in the measurement of insulin resistance. “We know that type-2 diabetes is preceded by a period of insulin resistance. Recent studies suggest that insulin resistance itself can lead to cardiovascular disease. The Diatest provides us with an accurate way of detecting insulin resistance and monitoring its response to therapy,” commented Dr Richard Lewanczuk, director, division of endocrinology and metabolism at the University of Alberta. “Additionally, the current popularity and success of low carbohydrate diets may be linked to insulin resistance, particularly in middle aged, over-weight patients. The Diatest would thus provide a useful way to confirm insulin resistance in these individuals.”
MedMira begins opening high-potential market in Caribbean
MedMira (Halifax) announced the company’s first steps in entering the promising Caribbean healthcare market with its latest product, the MiraWell triple test, in association with Caribbean Medical International (CMI), an established and well-known Curacao-based company that distributes health care products to medical clinics. MedMira has confidence that this move will open up a new region with great potential for its global health technology. The MiraWell triple test is based on MedMira’s rapid and easy-to-use technology platform; a one-of-a-kind diagnostic test for the simultaneous detection of antibodies to HIV, Hepatitis B and Hepatitis C. The company says that with extremely high accuracy, a built-in control feature, no requirement for refrigeration, a long shelf life and testing able to be done in virtually any medical office or clinic, its technology is ideally suited to provide front-line health service in regions like the Caribbean and throughout the developing world.
Xillix provides update on submission
Xillix Technologies (Richmond), a world leader in fluorescence endoscopy, confirmed that it believes the US FDA’s review of its request for continued access is progressing favorably. The company has also requested a meeting with the FDA to consider converting its request for continued access into a request for expansion of the original Onco-LIFE clinical trial approved by the FDA. Expansion of the clinical trial and enrollment of additional patients will delay submission of the pre-market approval supplement by a few months. The company will issue further updates as soon as it discusses this request with the FDA and additional information becomes available.
Perlegen Sciences and Galileo Genomics form collaboration
Perlegen Sciences, (Mountainview, CA) and Galileo Genomics (Montreal) announced a collaboration to rapidly develop a Quebec linkage disequilibrium map (QLDM) consisting of approximately 40,000 single nucleotide polymorphisms (SNPs) chosen to represent the specific patterns of linkage disequilibrium (genetic sharing) in the Quebec founder population. The companies will use the QLDM to conduct genome wide scans on DNA samples from individuals collected by Galileo, using haplo
type sharing, in 21 common diseases. Perlegen is a leader in high-density SNP genotyping technology. The company has identified SNPs that, because they were derived from haploid (single) chromosomes, accurately characterize the extent of genetic sharing in most regions of the human genome for general populations. Galileo has collected over 18,000 DNA samples from patients with precisely defined phenotypes and their relatives in over 20 common diseases through its collaboration with over 700 clinical investigators in Quebec. The company will increase this unique and powerful asset to 35,000 samples by 2005. The company applies proprietary algorithms to genotyping data from trios of a patient and two close relatives to detect disease genes with a sensitivity very substantially higher than conventional approaches.
Genetic marker might identify Leprosy-prone
Scientists said Sunday they had identified two DNA patterns that might help identify people most likely to catch leprosy, a highly infectious but curable disease. The genetic markers could be easily found by diagnosis or screening and could identify people who may not develop the disease but could harbor the infectious agent. “They are risk markers for leprosy and very significant ones,” Erwin Schurr, of McGill University in Montreal, Canada said in an interview. Although leprosy can be diagnosed and cured, it still afflicts 700,000 people each year. Scientists are puzzled about why it is so persistent. “We do not know where these 700,000 new cases each year come from because every case gets picked up and is treated quite efficiently and there is no known (drug) resistance or animal or human reservoir,” Schurr explained. “The markers may give us a handle to find the reason why leprosy has not gone away,” he added. Schurr suspects some people could act as reservoirs, harbouring the infectious agent, but he stressed it is just a hypothesis and said more research is needed.
5) Industry Update
Medical Ventures (Richmond), a medical technology company specializing in developing and commercializing cardiovascular medical devices, announced that it has appointed Canaccord Capital and Raymond James Securities to act as the company’s agents in connection with a private placement of units on a reasonable best efforts basis at a price of $0.90 per unit.
ID Biomedical (Vancouver) announced that it has appointed vaccine industry executive, Mr Mustapha (Staph) L Bakali, as its new chief operating officer. Mr Bakali was formerly the chief operating officer and member of the board of directors of British vaccine company PowderJect Pharmaceuticals, until its recent sale to Chiron Corporation.
ART Advanced Research Technologies (Montreal) announced the engagement of Biosector 2, an integrated healthcare communications agency, to lead ART’s worldwide public and investor relations programs in 2004.
ChondroGene (Toronto) reported that it has received a C$1.31 million (US$1.0 million) payment from Pfizer (NYSE:PFE) in conjunction with achieving the second research milestone in the joint Pfizer/ChondroGene drug target identification program for osteoarthritis (OA).
Kane Biotech (Winnipeg), a biotechnology company engaged in the development of products to prevent and disperse bacterial biofilms, is pleased to announce the appointment of Dr Geoffrey Grant to its board of directors. Dr Grant brings 30 years of pertinent industry and academic experience to the board.
World Heart (Ottawa) announced that it submitted an application to the US FDA on January 26th, 2004 to commence a pivotal study under the existing investigational device exemption (IDE) for use of Novacor LVAS for destination therapy (the “Trial”). A response from the FDA is anticipated approximately 30 days from the date of submission.
Pharmaceutical developer Dimethaid Research (Toronto) has announced an exclusive agreement with Jaba Farmaceutica, to distribute Pennsaid -the company’s prescription anti-arthritic lotion-throughout Portugal, Madeira and the Azores. The territory represents a market estimated to be annually worth EUR 156 million.
Ecopia BioSciences (Montreal) announced it has accepted today an offer from Desjardins Securities to purchase 7,352,942 units, each unit consisting of one common share and one-half of one common share purchase warrant.
Pheromone Sciences (Toronto) announced that it continues to evaluate its operational and financial options. As previously announced the company has scaled down all operations to provide maintenance working capital while it continues discussions with interested parties in the company’s fertility monitor product. To this end, the company has laid off all employees. All severance requirements have been met.
ChondroGene (Toronto) announced that Dr Victor J Dzau of the Harvard Medical School has joined the company as a senior scientific advisor.
CML Healthcare (Mississauga) announced that its subsidiary, Cipher Pharmaceuticals, has signed an exclusive North American distribution and supply agreement for its novel formulation of fenofibrate with Reliant Pharmaceuticals.
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: firstname.lastname@example.org).