Life sciences news briefs (June 02, 2003)

Ottawa, ON June 2, 2003 The following life sciences news briefs were recently reported by Industry Canada.

1) Pharmaceuticals Update

Axcan presents results of a pilot study on mesalamine rectal gel

Axcan Pharma (Mont St Hilaire) presented results of a pilot study on the efficacy of mesalamine rectal gel in distal ulcerative colitis. This new formulation, acquired from Gentium for the North American market, is easier to administer than the currently marketed aqueous suspension enema. Axcan’s study assessed the efficacy of mesalamine enema in a gas-propelled gel form that has been used for many years in Europe for the treatment of distal ulcerative colitis. The pilot study, part of a pharmacokinetic assessment, looked at the efficacy and safety of mesalamine gel in patients with mild to moderate distal ulcerative colitis. Patients were included in this study on the basis of a disease activity index greater than three. Each patient received a single rectal dose of 4 g of mesalamine in 60 mL gel and, starting 48 hours after this first dose, they all received a similar dose for 4 consecutive days. Exploratory statistics by paired t tests showed a statistically significant difference between baseline and end-of- treatment disease activity index (p=0.0009).

Cells normalized by application of GAP43a may treat metastatic cancer

Pharmagap (Ottawa) announced that company scientists have conclusively demonstrated, by in vitro testing, that its first drug candidate, GAP43a, is effective on the targeted enzyme in Neuroblastoma cancer cells. Proper pathway signals are re-established through this enzyme, correcting gap junction operations, which should make cancer cells behave like normal cells. PharmaGap sees this molecule as a viable treatment for lung cancer, breast cancer and prostate cancer as well. PharmaGap had previously demonstrated such changes in cancer cells with preliminary, partial molecules that were not considered selective, nor amenable to in vivo use. The current successful in vitro demonstration utilizes the complete molecule, GAP43a, and Neuroblastoma cells in cultures. PharmaGap views its new drug candidate, in addition to being an anti-cancer drug, as a compound to be used to minimize resistance to chemotherapy.

Montreal the least expensive location for biotech: survey

The cost of running a biotechnology company’s research and development facility is significantly cheaper in Montreal than in other leading biotech regions, according to a recent analysis by a corporate relocation firm. Operating a 100-person biotech facility in the Montreal area costs US$7.96 million annually, vs. US$12.1 million in San Jose the most expensive metropolitan area in the country for a biotech company to be, reports the Boyd Company of Princeton, NJ. John Boyd, president of the Boyd site selection firm, said the “cost of doing business is a white-hot issue in corporate site selection. Our clients are concluding that the only way to improve the bottom line is by reducing costs. There is little help on the revenue side.” Of the 48 regional sites surveyed by Boyd, Montreal was the least expensive.
Lorus to advance its anticancer drug, GTI-2501 into phase II clinical trial

Lorus Therapeutics (Toronto) announced its intention to move its antisense, anticancer drug, GTI-2501 into a phase II clinical trial for the treatment of advanced metastatic prostate cancer in the fall of 2003. GTI-2501 reduces the expression of the R1 component of ribonucleotide reductase to prevent tumor cell growth. Data from phase I clinical studies nearing completion meet the safety and tolerability milestones required for advancement to a phase II clinical trial. In preclinical investigations, GTI-2501 selectively and specifically inhibited tumor growth across a broad range of tumor types, including several models of prostate cancer. This included both hormone dependent prostate cancer, and prostate cancer that is resistant to hormone blocking drugs. GTI-2501 also significantly enhanced the anti-tumor effects of standard agents currently used for the treatment of prostate cancer.

Isotechnika expands immunosuppressive drug pipeline

Isotechnika (Edmonton) announced that the company is developing a novel immunosuppressive compound called TAFA93. This new therapeutic is a small molecule mTOR inhibitor; a class of drugs currently used in the prevention of organ rejection in transplantation and as a coated stent therapy in the treatment of coronary artery disease. The mechanism of action of TAFA93 is distinct from calcineurin inhibitors such as ISA247, Isotechnika’s lead drug. Therefore, TAFA93 has the potential to be administered as a complimentary therapy with ISA247 in the prevention of organ rejection after transplantation. In early preclinical studies, TAFA93 is demonstrating promising pharmacokinetic results which are distinct from other drugs in its class such as Rapamycin. The company is committed to advancing this new compound as quickly as possible.

2) Diagnostics and Therapeutics Update

Study shows nighttime dosing of Biovail’s Cardizem LA more effective
Bedtime dosing of a new graded-release version of diltiazem, Biovail Corporation’s (Toronto) Cardizem LA (diltiazem HCI extended release), lowered diastolic blood pressure, heart rate and rate-pressure product, a strong correlate of myocardial oxygen consumption, more effectively in African-Americans than did Norvasc, the number one branded prescription anti-hypertensive, according to a study presented today at the 18th Annual Meeting of the American Society of Hypertension. The benefits of Cardizem LA were most pronounced in the morning when the incidence of heart attack and stroke are elevated by as much as 49%.

Paladin licenses Visicol from InKine

Paladin Labs (Montreal) and InKine Pharmaceutical Company, announced that they have entered into a Canadian licensing agreement for Visicol, the first patented sodium phosphate purgative in tablet format available in the United States. Visicol is used to cleanse the bowl prior to a colonoscopy. As consideration for the license, Paladin has paid an undisclosed up-front license fee, with additional royalties due to InKine based on future net sales of Visicol. Colonoscopy is a commonly used screening technique for colon cancer. There are approximately 300,000 colonoscopies performed in Canada each year carried out almost exclusively by 300 gastroenterologists.

Transition Therapeutics completes its phase I clinical trial

Transition Therapeutics (Toronto) announced that it has completed enrollment and dosing for its phase I human clinical trial of its interferon enhancer (“EMZ701”). Twenty healthy volunteers were enrolled in the study to evaluate the safety and tolerability of EMZ701. All of the safety data collected indicated that treatment was well tolerated with no safety concerns raised. No significant adverse events were observed. Final clinical findings will be forthcoming. Transition’s interferon enhancing therapy was significantly more effective than interferon alone in reducing both symptoms and pathologies associated with MS in different animal models. In addition, interferon enhancing therapy has been shown to have more potent anti-viral and anti-proliferative effects than interferon alone and therefore may have applications in Hepatitis C, Hepatitis B and Cancer. Interferon is the current standard in the treatment of MS and is also used for the treatment of hepatitis C, hepatitis B and cancer. Worldwide sales of interferon are estimated to be approximately US $5.3 billion.

3) Medical Devices

Trial finds capsule endoscopy safe and effective for pediatric use

Clinicians from St Justine Hospital in Montreal announced that their recently completed study demonstrated that the M2A capsule endoscope could safely and accurately diagnose small bowel disorders in children. The results of the study, presented at Digestive Disease Week 2003, demonstrate that capsule endoscopy offers a more accurate and non-in
vasive approach for diagnosing small bowel disorders in children over the age of ten when compared to traditional imaging modalities. Ernest G Seidman, MD, Chief, Division of Gastroenterology, at Sainte-Justine Hospital in Montreal, and his team conducted this comparative, self-controlled study involving 30 pediatric patients between the ages of 10 and 18.

Antibody coated stent developed by St Michael’s Hospital researcher

An innovative medical discovery that has the potential to vastly improve the lives of people suffering from coronary artery disease was implanted today in the first human patient. The antibody coated stent, developed by Dr Michael Kutryk, a cardiologist and clinician scientist with St Michael’s Hospital (Toronto) and assistant professor, University of Toronto, was implanted into the first human patient at Thoraxcenter, University Hospital Rotterdam in Holland. The procedure was transmitted via a live feed to the EuroPCR Conference in Paris, France a conference of over 10,000 interventional cardiologists.

CryoCath’s Freezor MAX Successfully treats first atrial flutter cases

CryoCath Technologies (Montreal) announced that its European-launched Freezor MAX catheter was used in seven recent atrial flutter cases at the Kerckhoff Klinik in Bad Nauheim, Germany by Dr H Pitschner. All seven cases resulted in acute successes. Atrial flutter is the second most commonly ablated arrhythmia with an estimated 24,000 procedures each year in Europe alone. The average procedure time for the cases was 1.7 hours and there were no complications or adverse events in any of the procedures and none of the patients reported experiencing any pain related to the ablation. This contrasts with radiofrequency ablation of atrial flutter where patients often report unacceptable levels of pain that require additional deep sedation or even general anesthesia.

4) Industry Update

Axcan Pharma (Mt St Hilaire) announced that it is increasing the price of its cash tender offer for all of the outstanding shares of common stock of Salix Pharmaceuticals, (NASDAQ: SLXP) to US $10.50 per share.

VSM Medtech (Vancouver) announced that its subsidiary, CTF Systems, has completed a contract for the sale and installation of a 275-channel OMEGA magnetoencephalography (MEG) system at No 85 Hospital of the Chinese People’s Liberation Army (PLA) in Shanghai. The contract marks the fourth OMEGA system VSM has sold into the expanding Chinese market since November 2001.

QLT (Vancouver) announced that it has strengthened its development organization with the addition of Maurice Wolin, MD, as Vice president, clinical research and medical affairs.

Oncolytics Biotech (Calgary) announced that it has been granted US Patent 6,565,831 entitled “Method of Preventing Reovirus Recognition for the Treatment of Cellular Proliferative Disorders.” Allowed claims in this patent cover co-administration of the virus with immune suppressing agents such as Cyclosporin. Additional allowed claims cover the use of the virus in combination with conventional therapeutic agents and treatments such as surgery, chemotherapy, and radiation therapy.

Theratechnologies (Montreal) announced that it has enrolled a first patient in a new Phase II clinical study for ThGRF, its growth hormone-releasing factor analogue, in HIV-related lipodystrophy, a syndrome which is characterized by a number of metabolic and physical abnormalities and affects a substantial percentage of patients on long-term HIV therapy.

Response Biomedical (Vancouver) announced the commercial launch of the RAMP Pox Test, the first rapid on-site environmental test capable of detecting orthopox viruses including smallpox, one of the most devastating diseases known to humanity according to the World Health Organization.

World Heart Corporation (Ottawa) announced that Technology Partnerships Canada (TPC) has agreed to amend its partnership agreement in order to complete the remaining $3 million disbursement under its November 2001 investment in support of WorldHeart’s HeartSaverVAD(TM) development program.

Bioniche Life Sciences (Belleville) and Fidia Farmaceutici have reached an agreement under which Bioniche recognizes the validity of Fidia’s patent for hyaluronic acid over which the parties were involved in litigation. Under the agreement, Bioniche, its German distributor and Fidia will drop all legal and patent actions.

Hemosol (Toronto), which has suspended trials of its blood substitute Hemolink, said it expects the results of a review of the product by an independent safety board in early July, about a month after it finishes its own review.

BioMS Medical (Edmonton) announced positive final results from its Phase II clinical trial for the treatment of multiple sclerosis (MS) with its synthetic peptide MBP8298. The MBP8298 peptide is designed to reduce the disease-associated production of a group of anti-MBP antibodies that are reactive with the central nervous system.

MIV Therapeutics (Vancouver) has announced it will not extend the license agreement dated May 17, 2002 with Endovasc, This agreement relates to the development of Endovasc’s PROstent technology. To date, all contractual obligations have been met by both parties.

GlycoDesign (Toronto) announced that the US Patent and Trademark Office has issued two patents covering the company’s ATH technology. ATH, a covalent complex between a super-active form of heparin and antithrombin, is a novel, potent antithrombotic.

Medical Services International (Edmonton) announced that it has agreed to appoint Comerita SA based out of Mexico as its distributor for its VScan Rapid Diagnostic Test Kits for Mexico.

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: vaillancourt.paul@ic.gc.ca).