Ottawa, ON – February 24, 2004 – The following life sciences news briefs were published recently by Industry Canada.
1) PHARMACEUTICALS UPDATE
Lorus Therapeutics’ study to investigate GTI-2040 and gemcitabine
Lorus Therapeutics (Toronto) announced the initiation of a clinical trial aimed at examining the clinical application of its antisense drug, GTI-2040, in combination with gemcitabine in patients with solid tumors. This study is part of a larger clinical development program sponsored and coordinated by the US National Cancer Institute (NCI) in collaboration with Lorus. Dr Chris Takamoto, the principal investigator, is an oncology researcher and director of pharmacokinetics at the Institute for Drug Development, Cancer Therapy and Research Center in San Antonio, where the study will be conducted.GTI-2040 and gemcitabine have complementary intracellular mechanisms of action for blocking DNA synthesis and subsequently inhibiting the growth of tumor cells. This convergence of drug mechanisms of action provides the potential for enhanced or synergistic effects when used in combination. The study will determine the recommended dose of GTI-2040 when administered with gemcitabine, an established chemotherapeutic agent. In addition, the study will evaluate the plasma pharmacokinetics and pharmacodynamics of each drug and examine cellular biomarkers that may correlate with clinical outcomes. One such biomarker is R2, the gene target of GTI-2040, and an essential component of ribonucleotide reductase, an enzyme required for cell division. The R2 component is elevated in many tumor types, and as such, suppression of R2 by GTI-2040 may serve as a biomarker for clinical response. Finally a number of clinical correlates will be investigated, in particular markers for apoptosis, or programmed cell death, which may represent an additional mechanism by which GTI-2040 selectively kills tumor cells.
Neurochem granted fast track designation from US FDA
Neurochem (Montreal) announced that the US Food and Drug Administration (FDA) has designated the company’s most advanced investigational drug candidate, Fibrillex, as a fast track product (FTP) for the treatment of secondary Amyloid A (AA) amyloidosis, a serious and life-threatening condition which develops as a consequence of chronic infections or chronic inflammatory diseases, such as Rheumatoid Arthritis (RA). Secondary AA amyloidosis (better known as AA amyloidosis) has a poor prognosis, with a five-year survival rate of approximately 50%. Left untreated, patients gradually progress to end-stage renal failure, which is the cause of death in at least 35% of the cases. As a result of the FTP designation, Neurochem will submit a request for a rolling new drug application for Fibrillex, enabling the FDA to commence review of portions of the application before the end of the on-going two-year phase II/III trial. Furthermore, the company is eligible for priority reviews by the FDA.
2) DIAGNOSTICS AND THERAPEUTICS UPDATE
Paladin signs exclusive distribution agreement for Replagal
Paladin Labs (Montreal), a leading Canadian specialty pharmaceutical company, announced that it has entered into an exclusive Canadian distribution agreement with Transkaryotic Therapies, for Replagal (agalsidase alfa), an innovative treatment for Fabry disease. Health Canada recently granted TKT regulatory approval for Replagal, a long-term enzyme replacement therapy for the treatment of Fabry disease under its notice of compliance with conditions (NOC/c) policy. Approval of a product under the NOC/c policy allows Health Canada to provide earlier market access to potentially life-saving drugs. Conditions associated with approval allow Health Canada to monitor the safety and effectiveness of the drug through enhanced post-market surveillance.
Nanogen to acquire SYN X Pharma
Nanogen (San Diego), developer of molecular diagnostic products for the gene-based testing market, and SYN X Pharma (Toronto), a point-of-care diagnostics company, announced the signing of a definitive agreement whereby Nanogen will acquire SYN X in an all-stock transaction by way of a court-approved plan of arrangement. The acquisition will provide Nanogen with a pipeline of complementary products in order to expand its market share in the in vitro diagnostics market and augments its technology platform for developing advanced diagnostic products.
FDA approves Xillix’s request for expanded clinical trial
Xillix Technologies (Richmond), a world leader in fluorescence endoscopy, announced that the FDA has approved Xillix’s request to expand the original Onco-Life lung cancer clinical trial. This will allow the US clinical investigators to continue using Onco-Life and will give Xillix the option to include additional patient data in its pre-market approval supplement submission if necessary.
3) MEDICAL DEVICES
WorldHeart announces medical milestone for Novacor LVAS
World Heart (Ottawa) announced that Mr Giordano Luppi, a 68-year old heart-failure patient in Carpi Italy, celebrates tomorrow six years of extended life, thanks to his Novacor LVAS (left ventricular assist system). This anniversary makes Mr Luppi the first person in the world to live six years with an implanted mechanical cardiac assist device. At the time of his implant, Mr Luppi was bedridden, suffering from cardiomyopathy, and tethered to a continuous infusion of drugs to sustain his life. Mr Luppi suffered other ailments, primarily severe emphysema, and was deemed ineligible to receive a donor heart by his physicians in Verona, Italy. As a result he chose to be implanted with a Novacor LVAS.
MIV Therapeutics completes drug-eluting stent coating R&D program
MIV Therapeutics (Vancouver) has successfully completed the first phase of its Hydroxyapatite (HA) drug-eluting stent coating R&D program sponsored in part by the Canadian government. The objective of the program was to develop multilayer biocompatible and bioactive calcium phosphate functionally graded coatings on stents. Two types of coatings were developed: a thin film coating of dense, crystalline hydroxyapatite (HA) designed to screen the metal surface from the surrounding tissue to prevent inflammatory response in the tissue and to provide a high-adhesion surface for the second coating; a thicker, porous, film of HA. The goal was to achieve formation of an adhesive hydroxyapatite layer suitable for the application of drugs. An extensive range of tests were performed to validate the reproducibility and integrity of the above coatings, and their suitability for use on cardiovascular stents and other medical devices, with a focus on drug encapsulation and drug eluting applications.
MedcomSoft to unveil a revolutionary new EMR product at HIMSS
MedcomSoft (Toronto) announced that it will unveil its new EMR product code-named (MP2C) at the Healthcare Information and Management Systems Society conference and exhibition in Orlando on February 24, 2004. MedcomSoft says its new product could potentially revolutionize the way secure, intelligent, complete and detailed clinical records can follow patients to virtually any point of care allowing providers, using a variety of different systems, to aggregate and analyze instantly any and all the patient data related to any of his conditions before the administration of further care. The adoption and use of this new product could very rapidly contribute to a dramatic decrease in medical errors, a decrease in redundant tests or duplication of procedures and a leapfrog towards the interoperability and portability of patient charts as described and mandated by the US Administration Health Insurance Portability and Accountability Act (HIPAA).
Gene fault increases leprosy risk
Scientists have discovered a gene fault that makes people more likely to develop leprosy. Although many perceive it as a “biblical disease”, leprosy still affects up to a million people a year. Experts from McGill University in Montreal,
found the genetic variation means a person has five times the normal risk of developing leprosy. Writing in the journal Nature Genetics, they say the finding will help develop ways to prevent and treat the disease. Leprosy is a chronic disease caused by the bacteria Mycobacterium leprae, which is passed on through direct personal contact or contaminated respiratory droplets. Symptoms include pigmented skin lesions, permanent nerve damage leading to numbness of the feet and hands. If it is left untreated, people can lose fingers, toes, feet or hands to the disease.
5) INDUSTRY UPDATE
Vasogen (Mississauga), a developer of immune modulation therapies for the treatment of cardiovascular disease and other chronic inflammatory disorders, today announced that it is commencing a public offering of 8 million common shares in the US and Canada.
Procyon Biopharma (Montreal) announced the appointment of James W Sutton, MD, as vice-president, clinical research & regulatory affairs, effective February 9, 2004. Dr Sutton will manage the clinical development and regulatory activities at Procyon and he will be a member of both the management committee and the scientific committee.
Isotechnika (Edmonton) announced that the company has been issued US Patent No. 6,686,454, titled “Antibodies to Specific Regions of Cyclosporine Related Compounds.”
YM BioSciences (Mississauga), a cancer drug development company with an advanced-stage portfolio, announced that the Toronto Stock Exchanges has accepted notice filed by the company of its intention to make a normal course issuer bid.
Theratechnologies (Montreal) has announced that it has filed a final short form prospectus with the securities commissions in all provinces of Canada with respect to a previously announced bought deal agreement totalling $13,627,500. Under this agreement, Theratechnologies will issue 3,950,000 common shares at a price of $3.45 per share.
Chronogen (Montreal), a drug discovery company developing human therapeutics to treat age-dependent diseases, announced today the appointment of Nahed Ahmed, PhD to the company’s board of directors.
Sonomax Hearing Healthcare (Montreal) announces that it has engaged Jennings Capital to act as its agent for a private placement of 10% convertible unsecured subordinated notes in a maximum amount of $6 million.
Response Biomedical (Vancouver), announced that it has engaged The Trout Group, a New York-based investor relations firm, to facilitate the company’s exposure to US capital markets by developing relationships with portfolio managers, investment bankers, industry analysts and the business news media.
Dimethaid Research (Toronto) and Solvay Pharma have announced a co-promotion agreement covering Canadian sales and marketing for Pennsaid, the country’s first prescription anti-arthritic lotion.
Medical Services International (Edmonton) announced that the company has appointed an exclusive distributor for Peru.
MedMira (Halifax) announced completion of the acquisition of 100% of the outstanding common shares of Seneca Equities of Calgary, Alberta, completing a qualifying transaction for Seneca. The combined companies will continue to operate under the MedMira name.
Diagnos (Longueuil) announces that it is negotiating with Systmes Mdicaux Imagem with regards to the utilization of Diagnos’ MCubiX software in order to improve their medical imaging management system. The company’s InterView system includes modules such as IMaRIS for departmental radiology management, IMaPACS for medical image archival and IMaWEB for Internet access to medical images.
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).