Ottawa, ON – April 29, 2004 – The following life sciences news briefs were published this week by Industry Canada.
1) Pharmaceuticals Update
Forbes Medi-Tech announces European Phase II trial data for FM-VP4
Forbes Medi-Tech (Vancouver) announced, further to the company’s April 5th news release and conference call, details from the additional data recently received from the European Phase II clinical trial of its cholesterol-lowering compound, FM-VP4. During the study and as previously indicated, FM-VP4 demonstrated a dose-response that was statistically significant. The data suggests that 400 mg/day may be the optimal dose, although further studies are required to confirm a plateau. Additionally, the time-response to FM-VP4 indicated that LDL cholesterol levels may continue to decrease when given to patients for longer than 4 weeks, the duration of the completed trial, and that optimal efficacy may not have been achieved.An evaluation of preclinical animal data in comparison to these Phase II results has also indicated the need to examine the effects of timing of FM-VP4 with respect to food intake on the drug’s efficacy.
AEterna subsidiary Zentaris announces initiation of dose ranging study
AEterna Laboratories (Quebec City), along with its wholly owned subsidiary Zentaris, announced the initiation of a dose ranging study for its EP-1572 growth hormone secretagogue (GHS), a novel, orally available peptidomimetic agent which can directly stimulate growth hormone secretion from the pituitary gland. The study will evaluate the safety and pharmacokinetics/pharmacodynamics of the compound administered by oral route and its initiation triggers an undisclosed milestone payment to AEterna from its development partner Ardana Bioscience. Potential indications for EP-1572 include treatment of growth hormone deficiency disorders in adults and children (short stature), frailty of the elderly, as well as metabolic complications associated with critical illnesses, such as AIDS-associated cachexia, cancer, and trauma.
Isotechnika receives approval for multiple dose range finding study
Isotechnika (Edmonton) announced that the company has received approval from Health Canada regarding the proposed multiple dose range finding study for trans-ISA247. The multiple ascending dose study involving approximately 36 subjects will be completed over a nine week period in Quebec, Canada. Dosing is scheduled to commence on June 3rd, 2004. The information gathered from this study will be used in conjunction with data collected in previous studies to determine the dosing of trans-ISA247 in future clinical trials for both psoriasis and renal transplantation. “The commencement of this study facilitates Isotechnika meeting its timelines to apply to the regulatory agencies to enter into a Canadian Phase III psoriasis trial by the end of the year,” stated Dr Randall Yatscoff, Isotechnika’s president & COO. “This approval represents another vote of confidence for ISA247 as we move this drug through the clinical trial process.”
2) Diagnostics and Therapeutics Update
ID Biomedical to acquire Shire Pharmaceuticals’ vaccine business
ID Biomedical (Vancouver) and Shire Pharmaceuticals announced that they have signed an asset purchase agreement related to the sale of Shire’s vaccine business to ID Biomedical. Closing of the transaction, which is conditional on approval of the Canadian government under certain government contracts, regulatory approvals and usual conditions of closing, is anticipated by no later than June 30, 2004. Under the terms of the agreement, upon closing, ID Biomedical will acquire all of Shire’s vaccine assets for a cash payment of US$60 million (payable $30 million on closing and $30 million on the first anniversary of closing) and subscription receipts allowing Shire to acquire approximately 5.4 million common shares of ID Biomedical representing additional consideration of US$60 million.
Roche and Isotechnika restructure collaboration
Roche and Isotechnika (Edmonton) jointly announced a restructuring of their collaboration agreement for the clinical development and commercialization of Isotechnika’s novel molecule ISA247. ISA247, which is a mixture of cis and trans isomers, was licensed to Roche in April 2002 as a Phase II compound in transplantation. Under the renegotiated terms, Isotechnika will solely manage and fund the clinical development of transISA247 (the trans isomer of ISA247), including single ascending dose (SAD) and multiple ascending dose (MAD) clinical trials. Upon successful completion of these trials, Isotechnika will conduct at its own expense, a Phase II study in renal transplantation, and Phase III studies in psoriasis. Roche will have the right to opt-in to the development and commercialization of transISA247 for transplant indications up to the end of the Phase II renal transplantation trial. Isotechnika retains all rights to develop and commercialize the product outside of transplant indications.
Super-antibodies break the cell barrier
Super-antibodies that can bind to targets within cells, rather than on their surface, could lead to a new range of treatments for diseases, a biotech company claims. “Most good targets for diseases are inside cells,” says Charles Morgan, president of InNexus Biotechnology of Vancouver, Canada, which has developed the super-antibody technology. Super-antibodies could be used to target bacteria and viruses (including HIV) inside cells, for instance, or abnormal proteins that turn cells cancerous. In theory, they could do everything that the small molecules of most conventional drugs do, and more. The beauty of a cell-penetrating super-antibody is that it would be highly discriminating. Because antibodies can be far more specific than small-molecule drugs, and because they are not inherently toxic, they should have fewer side effects. The big disadvantage is that antibodies have to be injected as they do not survive in the stomach.
Scientists correct cystic fibrosis defect in mice with turmeric extract
Scientists at the Hospital for Sick Children and Yale University School of Medicine have found that a compound in the spice turmeric corrects the cystic fibrosis defect in mice. The laboratories of Drs Marie Egan, Michael Caplan (both at Yale University School of Medicine), and Gergely Lukacs (Sick Kids) demonstrated in a mouse model that curcumin treatment can release the mutant CFTR protein from this inappropriate compartment inside the cell and allow it to reach its proper destination, where it is able to function. Furthermore, oral curcumin treatment was able to correct characteristic cystic fibrosis defects in a mouse model of the disease. Curcumin is a compound found in turmeric, and is what gives the spice its bright yellow colour and strong taste.
3) Medical Devices
Nearly 20 years ago, Florida resident Robert St Laurent, then 51 years old, received the Worldheart (Ottawa) Novacor LVAS (left ventricular assist system) in the world’s first implantation of an electrical left ventricular assist system. He later became the world’s first successful bridge to transplant patient and recently celebrated his approaching 20th year anniversary at the annual reunion of Stanford University heart and lung transplant patients.
Bioniche acquires cue-mate reproductive technology from Pfizer
Bioniche Life Sciences (Belleville) has acquired from Pfizer the intellectual property and other assets of the Cue-Mate business, an innovative livestock reproductive technology. Cue-Mate will complement the range of reproductive technologies and services developed and marketed by Bioniche Animal Health, a division of Bioniche Life Sciences Cue-Mate is a uniquely designed progesterone delivery device for cows that allows dairy farmers and cattle producers to plan and manage the reproductive timing of their herds. Cue-Mate is currently registered and commercially available in Australia, New Zealand, Chile, and Argenti
Medical Services International additional test gets positive results
Medical Services International (Edmonton) announced that in an evaluation of its VScan HIV 1&2 rapid test kit by the University of Maryland it achieved a sensitivity of 100%. The tests samples were from different parts of the US and from Uganda, Thailand, Trinidad, Ivory Coast and India. These test results further verify the accuracy of the VScan HIV test kits and will be used in regulatory filings in the US. The VScan rapid test kit is a single use, easy to use test for screening of HIV 1&2 and subgroup O, Hepatitis B&C, Tuberculosis (TB) Dengue Fever and West Nile. The kits cannot be sold in Canada.
Positive results with Androflo
Andromed (Montreal), an innovative medical technology company, announces that the results from a clinical study on its non-invasive respiratory monitor, Androflo, were positive. Androflo is a non-invasive system that converts tracheal sounds detected on a patient’s throat using Andromed’s Androsonix acoustic biosensor into estimates of respiratory rate and other ventilation parameters.
4) Industry Update
Viventia Biotech (Toronto) a Canadian biopharmaceutical company focused on the development of targeted therapeutics against cancer, announced today that the company has received the amount of $500,000 in the form of an unsecured demand loan from Mr Leslie Dan, a significant shareholder of the company.
Hemosol (Toronto) announced that, at the annual and special meeting held earlier today, security holders overwhelmingly approved a resolution authorizing the previously disclosed arrangement involving Hemosol, its securityholders and MDS Under the arrangement, Hemosol will, in effect, exchange a significant portion of its tax losses and other tax assets for a cash infusion of $16 million.
Chronogen (Montreal), a drug discovery company developing human therapeutics to treat age-dependent diseases, announced today the appointment of Mr Kees Been, to the company’s board of directors.
The Leadership Fund (Toronto) and Naturale Science Pharma are pleased to announce that the corporation has entered into an agreement for the reverse-take-over of Naturale Science Pharma.
Tm Bioscience (Toronto) developer of DNA-based diagnostic tests, announced the commercial launch of the Tag-It Cystic Fibrosis ASR products, manufactured to analyte specific reagent regulatory specifications, for the detection of mutations in the gene associated with Cystic Fibrosis.
Inflazyme Pharmaceuticals (Vancouver) announced that they have completed their acquisition of Adprotech Inflazyme issued approximately 12.7 million common shares in exchange for all of the issued and outstanding shares of Adprotech. Adprotech shareholders will now hold approximately 12% of the outstanding Inflazyme common shares. Adprotech shareholders have agreed to a lock up of their shares, which will be released on a percentage basis from a date four months after completion of the acquisition.
QLT (Vancouver) reported that its alliance partner, Novartis, announced global Visudyne (verteporfin) sales of approximately US$101.1 million for the quarter ended March 31, 2004. This represents an increase of 23% over sales in the first quarter of 2003.
Draxis Health (Mississauga), has successfully closed its offering of 3,053,436 units at a price of C$6.55 per unit for gross proceeds of approximately C$20 million.
Transition Therapeutics (Toronto) announced that it has received conditional approval to list its common shares on the Toronto Stock Exchange.
QLT (Vancouver) announced that Visudyne (verteporfin), currently the only treatment for some forms of “wet” age-related macular degeneration (AMD), was reimbursed in Japan. Visudyne was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) in October 2003 for the “wet” form of AMD with all types of subfoveal choroidal neovascularization (CNV).
Life Sciences News Briefs 2004 is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Sandy Vien; Tel: 613-941-6479; E-mail: email@example.com).