Ottawa, ON May 21, 2003 The following life sciences news briefs were published this week by Industry Canada:
1) Pharmaceuticals Update
QLT discontinues tariquidar Phase III non-small cell lung cancer trials
QLT (Vancouver) announced that it will stop its current Phase III tariquidar trials in non-small cell lung cancer. This decision was made by QLT following a recommendation by the Independent Data Safety Monitoring Committee (DSMC) who completed the unblinded review of the data for both ongoing trials in this indication. Members of the company’s clinical development team will now be unblended so that they have opportunity to review all of the data and can make informed decisions about plans for future development of tariquidar. Data from the 304 patients already enrolled in these studies represents the largest collection of efficacy and safety data from randomized, placebo-controlled studies of a third generation P-gp inhibitor and will offer valuable insight into the potential for tariquidar in this or other indications. It is QLT’s intention to exploit the value of this database and make planning decisions for tariquidar after a thorough analysis of such data.
Micrologix Biotech provides guidance on timing of MBI 226 results
Micrologix Biotech (Vancouver) issued its quarterly CEO message in which Dr Jim DeMesa, president and CEO, provided comments on various company activities, including an update on the timing of results for the Phase III trial of MBI 226, now anticipated to be available by mid-August, 2003 (previous guidance had indicated a more general timeframe of third quarter 2003). In addition, Micrologix, in collaboration with Fujisawa Healthcare, recently completed a face-to-face pre-new drug application (NDA) meeting with representatives of the US FDA. During the meeting, the FDA discussed the preparation of the NDA for MBI 226 and provided useful recommendations for a successful submission. With a positive outcome in the Phase III trial, Fujisawa and Micrologix say they anticipate filing of the NDA in the first half of calendar 2004.
Ecopia’s drug discovery platform yields another lead compound
Ecopia BioSciences (Montreal) announced solid progress in its pipeline-building efforts with the discovery of a lead compound originating from its drug discovery factory. This compound, called ECO-14401, is a new chemical entity with antifungal activity. Earlier this year, Ecopia announced the discovery of the first two compounds, ECO-02301, a potential antifungal agent of a new chemical class and ECO-04601, a new chemical entity with anticancer activity.
SYN X Pharma initiates promised cost-reduction plan
SYN X Pharma (Toronto) announced that it is implementing its strategic cost reduction program. The cost reduction program will be a key factor in extending SYN X’s financial resources until the launch of its rapid point-of-care Nexus Dx congestive heart failure (CHF) diagnostic aid expected later this year. SYN X has four other innovative point-of-care diagnostic products in various stages of development in the areas of congestive heart failure, traumatic brain injury, insulin resistance and type1 diabetes. The implementation of the cost-reduction strategy involves the reduction in the number of employees by approximately 30%.
2) Diagnostics and Therapeutics Update
Adherex signs screening agreement with National Cancer Institute
Adherex Technologies (Ottawa) announced that it has entered into a screening agreement with the National Cancer Institute (NCI) of the US. Under the agreement, the NCI will evaluate the anticancer effects and vascular targeting capabilities of select compounds from Adherex’s broad library of proprietary cadherin antagonists. The NCI will assess the selected drug candidates in vitro as well as in preclinical animal models. The classes of agents to be included under the agreement include peptide cadherin antagonist compounds for N-cadherin, E-cadherin, desmogleins, VE-cadherin and OB-cadherin, as well as Adherex’s third generation small molecule, non-peptide cadherin antagonists.
Lorus allowed US patent for antisense antimicrobial drugs
Lorus Therapeutics (Toronto) announced that the US Patent Office has allowed a patent, which protects the antimicrobial component of the company’s antisense drug development program. The patent titled, ‘Antisense Oligonucleotide Sequences As Inhibitors of Microorganisms,’ protects Lorus’ technology on the design and use of unique antisense, antimicrobial agents that target specific gene sequences. The patent covers the gene targets, SecA and Ribonucleotide reductase (RNR), which are necessary for growth and viability of microorganisms. SecA is an important component of a process required for secretion of bacterial proteins, which is an essential event in the life cycle of pathogenic organisms. RNR is a central enzyme in the formation of components required for DNA synthesis and proliferation. Since the functions of these gene products are needed for survival they are ideal targets for drug development strategies.
Transplantation Technologies announces name change
Transplantation Technologies (Toronto), a privately held biotechnology company specializing in the development of innovative therapies for the treatment of immune-mediated conditions, announced that the new name, Trillium Therapeutics Inc. (TTI) was unanimously approved at its April 10 shareholders meeting. TTI, which recently raised C$7.5 million in a Series A financing led by the Vengrowth Advanced Life Sciences Fund, also announced that Dr Robert Uger has joined the company as director, research & development. TTI is a privately held research and development (R&D) company based in Toronto. The company specializes in the development of innovative therapies aimed at restoring balance to the immune system in conditions associated with aberrant and harmful immune responses, such as autoimmune and inflammatory disorders, graft rejection and viral hepatitis. The company’s business model is to identify therapeutic candidates with promising efficacy profiles in animal models and to rapidly advance these into clinical testing. TTI is concentrating its activities on pre-clinical and early clinical development, with the primary objective of demonstrating safety and efficacy in humans.
3) Medical Devices
CryoCath gains key US patent to promote angiogenesis
CryoCath Technologies (Montreal), which develops cryotherapy products to treat cardiovascular disease, announced the US Patent and Trademark Office has granted the company a new method and device patent, US 6,546,932, providing broad coverage for CryoCath’s arteriogenesis program, a novel therapy for the more than 500,000 patients worldwide suffering from chronic cardiac ischemia. Cardiac ischemia is inadequate blood flow to a region of the heart, often resulting in severe angina (chest pain). The patent describes the method by which a flexible catheter is used to deliver cryotherapy in the range of -20 degrees C to -80 degrees C to trigger an angiogenic response in any tissue. Angiogenesis is the term used to describe the formation of new blood vessels. Arteriogenesis, a subset of angiogenesis, refers to the formation of new arteries, the type of blood vessel that carries oxygenated blood to the tissues. The patent also covers various catheter configurations and the combination of cryotherapy and drugs to stimulate the formation of new blood vessels.
Tm Bioscience expands product pipeline
Tm Bioscience (Toronto) announced the addition of two new genetic tests to its development pipeline. The Tag-It Mutation Detection Kits for P450-2C9 and the Tag-It Mutation Detection Kits for P450-2C19 will be used to identify the presence or absence of important mutations common in patients with atypical drug metabolism, which can lead to adverse drug responses, a major cause of hospitalization in North America. The company anticipates that the Tag-It P450-2C9 test will be commercially available by the
end of 2003 and the Tag-It P450-2C19 test in the first half of 2004.
4) Genomic Update
Gene that controls susceptibility to tuberculosis discovered
Investigators at the Research Institute of the McGill University Health Centre (Montreal) have identified a gene that regulates the susceptibility to tuberculosis. This finding is published in this week’s edition of the Proceedings of the National Academy of Sciences. Tuberculosis, an infectious disease caused by the bacteria Mycobacterium tuberculosis, affects approximately 1.9 billion people worldwide. However, a large proportion of these individuals do not develop tuberculosis symptoms. Their body defense systems, or immune systems, are capable of controlling the growth of the bacteria. “We have identified a gene that controls Mycobacterium tuberculosis growth in the lung,” says MUHC microbiologist and senior author Dr Philippe Gros. “This is an important step toward understanding why some infected individuals are able to fight off the infection and others are not. This discovery may lead to innovative prevention and treatment strategies for the two million patients who die from tuberculosis yearly.”
5) Industry Update
CryoCath Technologies (Montreal) announced that it has received the CE Mark for Freezor MAX for the treatment of cardiac arrhythmias such as Atrial Flutter. The CE Mark allows the company to sell the product in all countries of the European Union.
ARC Pharmaceuticals (Vancouver) announced the appointment of Dr John North to the company’s board of directors.
Inflazyme Pharmaceuticals (Vancouver) announced that patient enrolment has now commenced for the Phase 2a asthma trial with IPL512,602, an oral, second generation LSAID(TM) (leukocyte selective anti-inflammatory drug), being developed in collaboration with Aventis Pharma.
Altachem Pharma (Edmonton) announced that the ethics committee for the Centre Hospitalier de l’Universite de Montreal has approved the protocol to allow Altachem to commence a Phase I double blind human clinical trial on ACP-HIP for the treatment of Kaposi’s sarcoma at their site.
Andromed (Montreal), a high-tech medical company, and Premier Purchasing Partners, a US healthcare purchasing group, have signed an agreement to promote the Androscope i-stethos, an advanced electronic stethoscope designed and manufactured by Andromed, to Premier’s network of 1,600 hospitals and healthcare systems in the US.
Medisys Health Group (Montreal), a national provider of healthcare services to corporations and insurance companies, today announced that it has acquired the remaining 50% interest in Medisys Corporate Health Services that was not already controlled by Medisys. Located in Vancouver, BC, MCHS provides executive and occupational health services to corporations. The clinic is reported to have generated approximately $1.6 million in revenues in fiscal 2002.
Cardiome Pharma (Vncouver) reported at its annual general meeting held yesterday that it would initiate Phase III trials for RSD1235, its anti-arrhythmic product, in the second half of 2003.
MedMira (Halifax) announced that it has completed the initial shipment of the Reveal Rapid HIV-1 antibody test to its US exclusive distributor, Cardinal Health. This initial shipment is the first delivery against the previously announced initial order of 500,000 coming less than a month after receiving FDA approval for this product.
Canada Health Infoway (Montreal) announced investments of approximately $135 million in nine projects across Canada focused on two of the key building blocks of secure, compatible and interoperable electronic health record (EHR) solutions: drug information systems and diagnostic imaging systems.
Medical Ventures (Richmond) announced that it has acquired Angiometrx, a privately owned medical technology company focused on the development and commercialization of the Metricath system.
Isotechnika (Edmonton) announced that it had achieved a significant development milestone pursuant to the terms of its collaboration agreement with Roche. In accordance with the agreement, the positive results of the recently completed Phase II clinical trial of ISA247 in patients with moderate to severe psoriasis entitled Isotechnika to receive a milestone payment of C$21,900,000. In April 2002, Isotechnika entered into a collaboration agreement with Roche for the global co-development and commercialization of its lead drug, ISA247.
Life Sciences News Brief is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Paul Vaillancourt; Telephone: (613) 952-7700; E-mail: firstname.lastname@example.org).