Life sciences news briefs (January 23, 2004)

Ottawa, ON – January 23, 2004 – The following life sciences news briefs were published this week by Industry Canada:

1) Pharmaceuticals Update

Lorus Therapeutics announces interim clinical results of GTI-2040

Lorus Therapeutics (Toronto) announced interim results from a recently conducted exploratory phase II clinical trial of GTI-2040 in patients with advanced, end-stage renal cell cancer in the US. This trial was a single-arm pilot study examining the safety and efficacy of GTI-2040 used in combination with the anticancer agent capecitabine. To date, data have been collected on 21 patients evaluable for tumour assessment. One patient is still receiving treatment after eight months of therapy with GTI-2040 and capecitabine. Four additional patients will be accrued. The majority of patients had failed two or more prior therapies before entering the study, exhibited extensive metastases, and were representative of a population with very poor prognostic outcome in renal cell cancer.

In the present clinical study, few treatment-related toxicities outside of those already known to occur with the test drugs were observed. Unaudited data analysis showed that more than half of the 21 evaluable patients in this study exhibited disease stabilization, ranging up to eight months. Tumor shrinkages of index tumours compared to baseline measurements were observed in some patients. A full assessment of tumour responses will be completed and a final independent review of results will occur following conclusion of the study.

AnorMED expands Fosrenol licensing agreement with Shire

AnorMED (Vancouver) announced that it has expanded the terms of its licensing agreement with Shire Pharmaceuticals Group plc for lanthanum carbonate (Fosrenol). The terms of the new license grant Shire exclusive rights to develop, manufacture, use and sell Fosrenol worldwide for all potential human indications and veterinary uses. Under the terms of the agreement, Shire will initiate a new clinical study of Fosrenol, based on its ability to bind oxalate, as a potential treatment for kidney stones. In consideration for expanding Shire’s rights to Fosrenol, AnorMED will receive an upfront payment of approximately US $180,000, receive a royalty on the sales of Fosrenol by Shire, and receive a percentage of net-income received by Shire from any veterinary sub-licensees.

Neurochem to continue pivotal phase II/III clinical trial for Fibrillex

Neurochem (Montreal) announced that, following the third meeting of its independent data safety monitoring board (DSMB), the company has received its third unanimous recommendation to continue its pivotal phase II/III clinical trial for its orphan drug candidate Fibrillex for the treatment of Amyloid A (AA) Amyloidosis, a disorder associated with chronic inflammatory and infectious diseases. The recommendation by the DSMB members was based on their recent review of the safety data from 183 patients of whom 77 have completed at least twelve months of the phase II/III clinical study.

2) Diagnostics and Therapeutics Update

NuPharma Has SARS ‘Solution’

NuPharma Laboratories (Toronto) has received verification their non-invasive disinfectant Virucidal Extra is effective at killing the SARS virus. This powdered disinfectant, when mixed with regular tap water becomes a very effective virucide, bactericide and fungicide (it has proven effectiveness against EColi, Salmonella, Coronavirus 229E, SARS and many others). Virucidal Extra is intended for use in hospitals, medical clinics, veterinary hospitals, airports, public buildings, nursing homes, offices and other places where bio-security is vital.

Blocker may save stroke victim’s life

In a landmark paper a Toronto neurosurgeon has sketched a chemical life-support system for stroke victims. Currently their best hope is clot-busting drugs to clear blocked vessels in the brain, but only one in 50 patients makes it to the hospital in time to prevent serious damage from oxygen deprivation. Then it is a wait to see how badly the brain is damaged. Research at Toronto Western Hospital, though, shows the worst damage occurs hours after the stroke, when lack of oxygen triggers a sort of chemical suicide. Researchers are close to developing a drug to block this reaction, which could be effectively administered up to six hours after a stroke or even by parametics in the ambulance. It has already worked on rats.

Axcan submits 1 g Mesalamine suppositories for approval in the US

Axcan Pharma (Mont Saint Hilaire) announced that it has submitted to the US Food and Drug Administration (FDA) a supplemental new drug application for a 1-gram mesalamine suppository dosage form for the treatment of ulcerative proctitis. Axcan already markets a 1-gram rectal suppository in Canada under the brand name of salofalk. In the US alone, the rectal mesalamine market is valued at approximately US$65 million annually. Axcan’s fiscal 2003 U.S. sales of Canasa, its 500 mg form of rectal mesalamine, amounted to US$16.2 million. According to IMS data at September 30, 2003, approximately 54% of all US gastrointestinal prescriptions for rectal mesalamine were written for Canasa 500 mg, making Canasa 500 mg the most prescribed brand of rectal mesalamine in the US.

ID Biomedical announces US patent grant for non-live FluINsure

ID Biomedical (Vancouver) announced that it has received an official notice of allowance from the US Patent and Trademark Office with respect to its patent application entitled Proteosome Influenza Vaccine. This newly issued patent covers Proteosome-based, non-live, intranasal subunit vaccine compositions for the prevention of influenza virus infection. The patent also covers methods to prepare the vaccine. Patent protection in the US for subunit Proteosome influenza vaccines extends to February 15, 2021. The company notes that allowance of this patent further enhances the strategic development of a broad intellectual property estate surrounding patented core technology based upon vaccine formulations comprising Proteosome adjuvant/delivery technologies.

Researchers develop model to help control West Nile outbreak

A University of Alberta researcher has developed the first model to predict risk of West Nile virus in North America a tool that could help prevent the infectious disease from becoming an outbreak. Dr Marjorie Wonham and her research team from the Centre for Mathematical Biology at the University of Alberta created a simple mathematical model using the dead bird counts collected in New York in 2000. Her research is published in the current issue of the Royal Society of London’s journal Proceedings. Tomas de-Camino Beck and Mark Lewis are co-authors on the paper.

PharmaGap to provide its unique 3-D cell model to US company

PharmaGap (Ottawa) announced that it has signed a research and development services agreement with a major US-based pharmaceutical company. PharmaGap will provide the unnamed company access to a unique cell-based 3-dimensional skin cell model that is based upon PharmaGap’s proprietary wound healing and skin growth media technology. The US company has contracted PharmaGap to refine the model in order to screen a variety of chemical compounds to assess trans-dermal permeability and metabolism. PharmaGap’s skin model targets a major need within the global pharmaceutical industry’s new drug development programs to develop cost-efficient and efficacious assays that can determine a compound’s Admet (absorption, distribution, metabolism, excretion & toxicity) profile, minimizing the use of animal testing. Of note, the European Union has announced a significant reduction in the use of animal testing by 2009.

3) GENOMIC

Ontario Genomics Institute forms partnership with performance plants

Performance Plants (Toronto), a Canadian agricultural biotechnology company, and the Ontario Genomics Institute (OGI) have partnered to fund promising genomics research and identify high-value commercial oppor
tunities in academia in an effort to nurture projects through the critical pre-commercialization process. “Ontario needs to shrink the gap between funded research and venture investment in the commercialization of its genomics discoveries,” said OGI president and CEO Ronnie Gavsie. “Partnering with Performance Plants gives OGI the opportunity to serve as a catalyst for moving research discoveries along the path towards commercialization.” For their first initiative, Performance Plants (PPI) and OGI will collaborate with Drs Marilyn Griffith and Barbara A Moffat of the University of Waterloo and Elizabeth A Weretilnyk of McMaster University to develop transgenic plants with enhanced agronomic traits.

4) Industry Update

CML Healthcare (Mississauga) announced that its subsidiary, Cipher Pharmaceuticals, has received an approvable letter from the FDA pertaining to its new drug application for its novel formulation of fenofibrate. In the letter, the FDA requested that the company, prior to receiving approval, provide additional details and answer questions relating to chemistry, manufacturing and labeling for the product.

Cangene (Winnipeg) is pleased to report that it is a winner in Canada’s 50 Best Managed Companies program for 2003, a program sponsored by Deloitte & Touche, CIBC, the National Post and Queen’s School of Business.

World Heart (Ottawa) announced that a heart-failure patient in Germany became the 1500th recipient of a Novacor LVAS (left ventricular assist system). OA Dr Latif Arusoglu, department for thorax and heart surgery at the Heart and Diabetes Center in Bad Oeynhausen, Germany carried out the implant.

ART Advanced Research Technologies (Montreal), a leading developer of bio-optical imaging technologies, is pleased to announce the appointment of Mr Warren Baker as chief operating officer and Dr Joseph Kozikowski as chief medical officer of ART (subject to regulatory approval).

LAB International (Laval), a fully integrated drug development company specializing in inhalation delivery, announced the closing of the acquisition of Focus Inhalation Oy (Focus), originally formed as a spin-off of Schering Oy in 2000. Through this acquisition, LAB obtains the novel, regulatory approved Taifun inhalation delivery platform, as well as a suite of late-stage inhalation-based therapeutics.

Bioniche Life Sciences (Belleville) announced signing of an agreement to purchase the assets of AB Technology of Pullman, Washington. Closing of the agreement is expected in February. A developer of embryo transfer media, materials and equipment for bovine and equine markets, AB Technology will operate as a unit of Bioniche Animal Health USA, a division of Bioniche Life Sciences. It says that synergies resulting from the merger will provide embryo transfer practitioners around the world with a market-leading range of superior livestock reproductive technologies and services.

Xenon Genetics (Vancouver) announced significant advances in its lead metabolic syndrome (SCD1) program. The company has selected clinical candidates for formal pre-clinical development, achieved in vivo efficacy in multiple clinically relevant animal models and expects to advance into the clinic within approximately 12 months.

Medical Ventures (Vancouver) announced that its Angiometrx Division has received EN ISO 13485:2000 and ISO 13585:CMDCAS registration for the development, manufacture and sale of medical devices.

CML Healthcare (Mississauga) announced that its board of directors has formally approved a plan of arrangement pursuant to which two new publicly-traded entities will be created: CML Healthcare Income Fund, an income trust that will own CML’s existing laboratory testing and medical imaging businesses; and Cipher Pharmaceuticals, a pharmaceutical company comprised of CML’s existing drug development and pharmaceutical research businesses.

Hemosol (Toronto) announced that it has received a final receipt from the Ontario Securities Commission on behalf of the securities commissions in the Provinces of Ontario and Alberta for its short form prospectus.

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