Ottawa, ON October 9, 2003 The following life sciences news briefs were published by Industry Canada this week.
1) Pharmaceuticals Update
Procyon reports positive results for PCK3145
Procyon Biopharma (Montreal) announced positive interim results for PCK3145, Procyon’s therapeutic drug indicated for hormone-refractory prostate cancer, a disease for which there is currently no effective therapy. The interim results from the first two cohorts of Procyon’s Phase IIa clinical trial show no drug-related adverse effects, PSA reduction in some of the patients and significant decline in a tumor metastasis marker, MMP-9. “These encouraging results clearly demonstrate that PCK3145 has the potential to significantly reduce tumor metastasis in hormone-refractory prostate cancer patients without safety concerns and adverse effects,” said Hans J Mader, president and chief executive officer of Procyon. “Based on these interim clinical results, we are quite confident that PCK3145 will obtain positive results with the next cohorts as well as with the following studies in a larger patient population,” he added.
Inex initiates new drug application for Onco TCS to the FDA
Inex Pharmaceuticals (Vancouver) announced that it has commenced a “rolling submission” by submitting the first of three major sections of a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing approval for its lead product, Onco TCS, for the treatment of relapsed aggressive non-Hodgkin’s lymphoma (NHL). David Main, president and CEO of INEX, said the first section of the NDA contains nonclinical safety and pharmacology data. The remaining two major sections of the NDA, clinical and chemistry, manufacturing and controls (CMC), will be submitted during the fourth quarter of this year.
Lorus announces global expansion of the Virulizin Phase III clinical trial
Lorus Therapeutics (Toronto) announced a major global expansion to clinical sites in Europe and South America of its current Phase III clinical trial of Virulizin in advanced pancreatic cancer. The clinical study is now operating at major oncology centres in Russia, Ukraine, and Romania, with additional sites in Poland, the Czech Republic, Hungary, Spain and Brazil in progress. The study is also ongoing at centres in the US, Canada and Mexico. To date, over 100 clinical study sites are involved in this international Phase III clinical trial. The Virulizin Phase III trial in advanced pancreatic cancer is a multi-centre, double-blind clinical study comparing Virulizin in combination with gemcitabine to gemcitabine and placebo in the first-line treatment setting. The study also includes a second-line treatment component involving Virulizin in combination with 5-FU, versus 5-FU and placebo. The primary efficacy endpoint of the study is survival. Secondary endpoints in the study include time to treatment progression, which analyzes the effect of Virulizin on key clinical benefit parameters such as pain, analgesic consumption, changes in weight, and performance status.
2) Diagnostics and Therapeutics Update
NRC Biotech enters strategic alliance with ProMetic Life Sciences
The National Research Council’s Biotechnology Research Institute and ProMetic Life Sciences (Montreal) announced the formation of a strategic alliance for the production and biopurification of therapeutic proteins. NRC-BRI and ProMetic Life Sciences have teamed up to provide a fully integrated service to biotech and pharmaceutical companies for the development and scale up of therapeutic protein production. Optimizing the production of expensive proteins is crucial to creating commercially viable therapeutic products. It is expected that the joint venture will become a showcase for ProMetic and NRC-BRI technologies and expertise in the field of expression and downstream processing of therapeutics.
Micrologix completes MBI 594AN Phase IIb acne trial
Micrologix Biotech (Vancouver), a developer of anti-infective drugs, has completed treatment of all patients in its Phase IIb clinical trial of MBI 594AN, a novel, antimicrobial peptide under development for the treatment of acne. More than 250 patients were enrolled in the trial. Results of the Phase IIb study are expected to be available in 5-8 weeks.
Tm Bioscience launches cystic fibrosis test
Tm Bioscience (Toronto) announced the launch of the 40-mutation Tag-It mutation detection kit for cystic fibrosis (CF40). Cystic fibrosis (CF) carrier screening is currently the world’s largest and fastest growing human genetic test market. “The Tag-It CF40 mutation detection kit, with an industry leading ability to identify the 40 most common genetic mutations in the CF gene, combines broad mutation coverage with unmatched speed, accuracy and cost,” said Greg Hines, president and CEO of Tm Bioscience. “We expect the CF40 test to be our flagship product for the next several years as this market continues to grow and mature.” The company also announced it has sold more than 4,000 CF40 tests in the third quarter. “This reflects the clear market need for this product and confirms the value of our Early Access Program in securing early-adopting key customers for our products,” said Dr Jeremy Bridge-Cook, vice president of business development and marketing.
Cytovax’s Phase I clinical trial meets all safety endpoints
Cytovax Biotechnologies (Edmonton) announced results from its Phase I clinical trial for its lead product Cytovaxine, a peptide conjugate vaccine for the prevention of infections caused by Pseudomonas aeruginosa. Analysis of the results showed that all of the safety endpoints were met and no serious adverse events were observed. In addition, immunogenicity data indicated that Cytovaxine elicited a specific antibody response at all dose levels tested.
DRAXIS granted U.S. patent for bifunctional compounds
DRAXIMAGE (Mississauga) has been granted a US patent for an important new family of chelating compounds that have significant potential for the development of imaging and radiotherapeutic agents to diagnose and treat diseases, including cancerous tumours or metastases.
Trillium and Medarex to develop fully human antibody therapeutics
Trillium Therapeutics (Toronto) and Medarex (Princeton) announced collaboration for the development of fully human antibody therapeutics. Medarex plans to use its UltiMAb human antibody development system to generate antibodies to disease targets identified by TTI. Under the agreement, the two companies expect to share equally the cost and responsibility of the development of antibody products. In addition, the two companies plan to jointly commercialize and share equally future revenues arising from any antibody products resulting from this collaboration.
Arius and Protein Design Labs sign agreement for collaboration
Arius Research (Toronto), a medical biotechnology company specializing in functional anti-cancer antibodies, and Protein Design Labs, (Freemont), a specialist in antibody humanization and development, today announced they have signed an agreement for a new three-year partnership to discover and develop antibodies for the potential treatment of cancer. Arius uses patented and proprietary processes to discover and identify antibodies that have the intrinsic ability to kill cancer cells.
McMaster researchers race to SARS vaccine development
Researchers at McMaster University (Hamilton) have turned a corner in the race to develop a vaccine for severe acute respiratory syndrome (SARS). A breakthrough has come with the work by professor Jim Mahony who cloned the gene that marks an important nuclear protein of the SARS virus. A research team at McMaster then inserted the nuclear protein gene into an engineered common cold virus, or adenovirus vector, and will shortly test this in animals for the protective effects.
3) Medical Devices
Angiotech commences bypass study using drug-loaded vascular wrap
Angiotech Pharmaceuticals (Vancou
ver) announced that it has commenced enrollment in a European study of its first human peripheral bypass study that will evaluate a proprietary drug-loaded vascular wrap. The drug-loaded wrap is designed to prevent or reduce stenosis (narrowing of the blood vessel) at the bypass attachment site. Patients diagnosed with peripheral vascular disease undergoing “below the knee” femoral-popliteal arterial bypass surgery, will receive a traditional graft or a graft plus Angiotech’s paclitaxel-loaded biodegradable vascular wrap. When applied to the outside wall of the vessel, the wrap delivers drug to the blood vessel wall in a targeted manner to prevent stenosis associated with bypass surgery.
4) Genomic Update
Lorus publishes results of novel gene therapy approach for colon cancer
Scientists at Lorus Therapeutics (Toronto) have published the results of experimental studies aimed at developing an anti-cancer gene therapy based on over-expression of a novel tumor suppressor gene in colon cancer cells. The results appear in an article entitled, “Adenovirus-mediated Ribonucleotide Reductase R1 Gene Therapy of Human Colon Adenocarcinoma” in the October 1 issue (Volume 9, issue 12, page 4553-4561) of Clinical Cancer Research.
5) Industry Update
CryoCath Technologies (Montreal) announced that it has entered into a definitive agreement with Investissement Qubec for a loan in the amount of C$20 million under the Biolevier program.
Medical Ventures (Richmond) announced that Performance Medical Devices (PM Devices), a subsidiary of Medical Ventures, received a National Research Council (NRC) Industrial Research Assistance Program (NRC-IRAP) financial assistance grant toinvestigate and develop new tissue technology. The initial investigation costs are estimated at $150,000, approximately.
Isotechnika (Edmonton) announced its intention to make a normal course issuer bid through the facilities of the TSX Exchange.
Bioartificial Gel Technologies (Montreal) a privately-held Canadian biotech company targeting the development of moist wound healing and advance skin care products, announced today that it has completed a financing round of CDN $7.8 million.
OncoGenex Technologies (Vancouver) a clinical-stage biotechnology company developing targeted therapeutics for cancer, announced the completion of a US$11.5 million financing, one of the largest biotech financings in Canada this year.
Biomira (Edmonton) announced that it has completed its financing, totaling US$16,290,000, with Rodman & Renshaw of New York acting as exclusive placement agent. The financing announced on September 22, 2003 was fully subscribed and is now closed.
Angiotech Pharmaceuticals, (Vancouver) announced that it has successfully closed its previously announced public offering of 5,000,000 common shares at a price of US$43.75 per share (CDN$59.01 per share). Gross proceeds of this offering will be US$218,750,000 (CDN$295,050,000). If the underwriters fully exercise their over-allotment option of 750,000 common shares, gross proceeds will be US$251,562,500 (CDN$339,307,500).
BCY LifeSciences (Toronto) announced that it has completed the patient treatment and follow up stage of its Phase II clinical trial to assess the efficacy of DCF 987 in the treatment of cystic fibrosis (CF).
World Heart (Ottawa) Novacor LVAS (left ventricular assist system) will be more easily available to American patients waiting for a donor heart as a result of an increase in reimbursement announced yesterday by the Centers for Medicare and Medicaid. The decision increases payments from approximately US$54,000 to approximately US$70,000 or more for each implant.
Adherex Technologies (Ottawa), a biopharmaceutical company, announced it was issued a new US patent that provides protection for its portfolio of cancer vascular targeting agents through specific protection for endothelial cell interactions. Endothelial cell adhesion is critical in vascular integrity.
ID Biomedical (Vancouver) announced that it has withdrawn its previously announced public offering of 5,000,000 common shares. As a result of general market conditions in the biotechnology industry, the financing terms available to ID Biomedical were unacceptable.
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: email@example.com).