Ottawa, ON – March 5, 2004 – The following life sciences news briefs were published this week by Industry Canada.
1) Pharmaceuticals Update
Stressgen reports HspE7 results from two clinical trials
Stressgen (Victoria) announced the results from two clinical trials for its lead compound, HspE7. The trials were designed to confirm previous results and primary endpoints for future Phase III pivotal trials. The company reported that its Phase II trial for recurrent respiratory papillomatosis (RRP) showed high statistical significance in its primary endpoint of lengthening the interval between surgeries. Stressgen has been pursuing RRP as its primary strategic focus and first indication for HspE7 since interim results were first available in early 2003, and plans to file a biologics license application for RRP in mid-2007. The company also reported that its clinical trial for anal dysplasia showed a treatment effect. Although the secondary endpoints of physician’s global assessment for anal dysplasia and a subset of patients with concomitant genital warts reached statistical significance, the trial did not meet its primary pathology endpoint. Twenty-eight percent of the time there was a disagreement, or discordance, in the results of the adjudicated read process among the pathologists reading the biopsies to determine whether the dysplasia downgraded from high grade to low grade or no dysplasia. In the adjudicated read process, if two pathologists disagreed on the level of dysplasia, a third pathologist arbitrated. The difficulty in obtaining consensus suggests caution in the design of any pivotal Phase III dysplasia trial with a pathological endpoint.
FDA agrees to clinical development plans for ISA247
Isotechnika (Edmonton) announced that the Food and Drug Administration (FDA) of the US during a recent teleconference call has agreed to the proposed dose range finding study for trans-ISA247 in humans. The single ascending dose study involving approximately 46 subjects will be completed over a six week period by MDS Pharma Services in Phoenix, AZ. Dosing is scheduled to commence on March 9, 2004. This study will be used as the foundation to determine dosing of trans-ISA247 in future clinical trials for both psoriasis and renal transplantation. “Based on analysis of previously collected data, trans-ISA247 is more bioavailable and therefore we expect to administer the drug at a lower dose than the previous formulation which consisted of an equivalent mixture of the two geometric isomers (cis and trans),” stated Dr Randall Yatscoff, Isotechnika’s president & COO. “This study coupled with the results from the upcoming QTc trial will facilitate Isotechnika making an application to regulatory agencies for commencement of Phase III psoriasis and Phase IIb renal transplant trials by the end of this year.”
AstraZeneca plans to build a $21 million training centre
AstraZeneca plans to build a $21 million training centre at the pharmaceutical giant’s headquarters in Mississauga, to be completed by 2005. The announcement follows on the heels of the company’s official opening of their $80 million dollar new offices and plant last summer. The company currently employs 900 people. AstraZeneca spends $2 million per week in Canada to develop new drugs and therapies. The training center will provide facilities for the company’s sales staff. In making the announcement, the president and CEO of AstraZeneca, Mike Cloutier, said, “Economic development ministers and health ministers across the country should work together and harness health care innovation to drive our economy.”
2) Diagnostics and Therapeutics Update
Echinilin proven to reduce duration of the common cold
The February issue of the Journal of Clinical Pharmacy and Therapeutics published an article describing what researchers at the universities of British Columbia, Alberta and Dalhousie describe as a breakthrough in the fight against viral infections such as the common cold and the flu. Their research was done using Echinilin, (pronounced: ee-kin-i-lin), which is a highly standardized form of Echinacea purpurea. Echinilin is the culmination of eight years of immunological studies done by scientists at Factors R & D Technologies (Calgary) in collaboration with researchers at the universities of Alberta, British Columbia and Dalhousie in Canada, as well as Heinrich-Hein University in Dusseldorf, Germany, and Karl-Franzens University in Graz, Austria. In contrast to other over-the-counter cold and flu treatments, Echinilin does not mask or suppress symptoms. Rather, clinical trials with human volunteers showed that Echinilin stimulates the immune system, which more quickly mounts an attack against the invading virus.
Generex subsidiary enters into collaboration to develop SARS vaccine
Generex Biotechnology (Toronto) announced that it has entered into a collaboration with Dr Bing Sun of the Chinese Academy of Science (IBC) in Shanghai to develop a SARS vaccine. Dr Sun has done pioneering work isolating SARS genes which can be used in a DNA vaccine. Antigen Express, Generex’s subsidiary, has developed proprietary and patented technologies to enhance the potency of DNA vaccines. Together they seek to create an effective DNA vaccine for protection against SARS infections. Antigen Express’ technology focuses on modulating immune responses mediated by T helper cells, a class of lymphocytes that plays many roles in the immune system, both enhancing and suppressing immune responses. T helper cells are essential for obtaining both robust and long lasting responses against infections, cancer and against specific antigens which are encoded in DNA vaccines.
SemBioSys and Syngenta enter agreement on protein and antibody
Syngenta and SemBioSys Genetics (Calgary) have entered into an agreement giving Syngenta access to SemBioSys’ proprietary oilbody based Stratosome Biologics and StratoCapture Purification Systems for the development of Syngenta’s biologic products. These two technologies hold the promise to significantly reduce the downstream purification costs of therapeutic proteins and monoclonal antibodies. Syngenta expects to use the oilbody technology across a number of existing and future products in its biopharmaceuticals pipeline. Financial details of the agreement, which includes an upfront payment, option exercise fees, milestones and royalties were not disclosed.
Magistral Biotech confirms the innocuousness of Libracol
Magistral Biotech (Montreal) announced that it successfully completed a clinical trial on volunteers. This clinical trial reconfirms the innocuousness of its star product Libracol, a product favoring a healthy cholesterol level and therefore contributing to the reduction of the risk of coronary diseases. Magistral also announces the preparation of a second clinical trial on the effectiveness of Libracol on volunteers.
Transition completes extended phase I clinical study
Transition Therapeutics (Toronto) announced the completion of an extended Phase I human clinical trial for its Islet Neogenesis Therapy (INT) lead product. The goal of the trial was to refine dosing ranges for a phase II trial in diabetic patients. Subjects received a combination of a fixed dose of 30 (micro) g/kg of G1 and a dose of E1 ranging from 0.3 (micro) g/kg to 1 (micro) g/kg. All subjects completed the escalation to maximum doses and no serious or unexpected adverse events were observed. “These positive results build on our earlier successful phase I trial. Transition is planning to file an IND in the third quarter and expects to commence a phase II clinical trial thereafter.” said Dr Tony Cruz, chairman and chief executive officer of transition.
3) Medical Devices
MedcomSoft forms business alliance with Plante & Moran, PLLC
MedcomSoft (Toronto) announced it has formed a business alliance with Plante & Moran, PLLC, the 11th largest accounting and management consulting firm in the U.S., to provide MedcomSoft’s structured and codi
fied electronic medical records and physician practice software to healthcare organizations. The software is a tool to assist healthcare providers in standardizing and exchanging patient information a priority initiative among healthcare providers, federal and state governments, insurers and consumers.
Angiotech stock tumbles on news of agreement
Shares of Vancouver-based drug developer Angiotech Pharmaceuticals tumbled as much as 9 per cent after Johnson & Johnson and Guidant said they were joining forces to promote a rival medical device. Guidant announced it had signed an agreement with Cordis, an arm of Johnson & Johnson, to co-promote Cordis’ drug-coated Cypher stent. A stent is a tiny mesh tube implanted after artery-clearing angioplasty procedures to relieve blockages and bypass aneurysms. The drug coating prevents the stent from clogging as quickly as non-coated stents. Boston Scientific is on the verge of receiving US regulatory approval to start marketing its Taxus stent in the U.S.. Angiotech supplies Boston with the drug that coats the stent.
WorldHeart receives FDA approval for Reliant Trial
World Heart (Ottawa) announced that it received conditional approval from the US Food and Drug Administration (FDA) to proceed with the Reliant (Randomized Evaluation of Novacor LVAS In A Non-Transplant Population) Trial. The data from this Trial will support a Premarket Approval (PMA) Supplement for use of Novacor LVAS by nontransplant eligible patients (Destination Therapy). The conditional approval permits immediate enrollment of up to 40 centers and up to 50 patients in the United States. Total enrollment will be at least 225 patients; with the final number subject to final discussions with the FDA. Enrollment of the remaining patients to complete the trial can proceed only after acceptance by the FDA of responses by WorldHeart to a number of questions or adjustments identified in the conditional approval letter.
4) Industry Update
Pharmaceutical developer Dimethaid Research (Toronto) has announced a Pennsaid supply and distribution agreement with European Rx Alliance member, Vianex S.A. The agreement gives the Athens-based company exclusive rights to sell Dimethaid’s anti-arthritic lotion in Greece, targeting a market valued at approximately EUR 71.5 million, annually.
Trillium Therapeutics (Toronto) announced that Dr Michael Moore, Chief Executive Officer of PIramed, has joined TTI’s Board of Directors.
Haemacure (Montreal) announced that PowerOne Capital Markets Limited has agreed to act as agent for its private placement, under which Haemacure will issue a maximum of 10 million units at a price of $0.50 per unit for total proceeds to Haemacure of $5 million.
Aegera Therapeutics, (Montreal) a leading Canadian biotechnology company, announced the closing of their Series C financing round. Led by the VenGrowth Advanced Life Sciences Fund am) to fund multiple clinical trials of its two lead drug candidates.
Transition Therapeutics (Toronto) announced the closing of its previously disclosed private placement financing issuing 23,076,923 common shares at $0.65 per share raising gross proceeds of $15 million.
Medical Services International (Edmonton) announced that it has now completed the “dyes” necessary to manufacture the specialized trade marked cassettes with the VScan trade marks on each cassette. The company has received preliminary approval for the cassettes by the appropriate regulatory bodies as part of the approval process for its VScan rapid test kits.
Tm Bioscience (Toronto) announced that it has received conditional approval to list its common shares on the Toronto Stock Exchange.
Isotechnika (Edmonton) announced that the company has received a notice of allowance for its US Patent Application titled, “Deuterated Cyclosporine Analogs and their use as immunomodulating Agents.” This notice of allowance, in addition to patent numbers 6,605,593 and 6,613,739, pertain to Isotechnika’s lead drug compound, ISA247.
(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: firstname.lastname@example.org).