Life Science News Briefs Vol. 6 no.30 - October 25, 2006

• Pharmaceuticals & Biotherapeutics Update
• Clinical Trials Update
• Medical Devices and Diagnostics Update
• Industry Briefs

Pharmaceuticals & Biotherapeutics Update

Breakthrough by MUHC researcher has major implications

Eye Health Month is off to an exciting start, with the recent announcement by MUHC researcher Dr. Robert Koenekoop and his colleagues of a breakthrough discovery in the genetics of childhood blindness. The new study identified the gene most often responsible for LCA (Leber Congenital Amaurosis), the commonest form of congenital blindness. "This discovery represents a significant advance in the fight against this debilitating condition." says Dr. Koenekoop, Director of the McGill Ocular Genetics Centre at the MUHC and Associate Professor in Ophthalmology, Human Genetics at McGill University. He is also principal co-investigator of this study with Dr. Anneke den Hollander, and Dr. Frans Cremers from The University of Nijmegen in the Netherlands. LCA causes blindness from birth or during the first few months of life. About 600 patients with LCA are currently being diagnosed and managed at the McGill Ocular Genetics Center of the MUHC, directed by Dr. Koenekoop. The disorder affects 1 in 30,000 newborns, and is currently incurable. "This is about to change, however," says Dr. Koenekoop. "Our discovery has major implications for improved screening. It also opens avenues for treatment of LCA." Discovery of the CEP290 gene and a single mutation found in 20 percent of LCA patients will significantly speed up the genetic testing process for blind children. From a therapeutic viewpoint, this discovery adds another pathway for possible therapeutic manipulation and paves the way for a human gene replacement trial of a related LCA gene (RPE65) in early 2007. If this trial is successful, gene replacement therapy may not be far off. Prior to Dr. Koenekoop's discovery, LCA had been linked to mutations in eight genes. Together, these mutations account for about 45 percent of cases. By studying members of a Quebec family affected by LCA, Dr. Koenekoop's team, which includes research associate and molecular biologist Dr. Irma Lopez, was able to identify a mutation in a gene known as CEP290. This mutation was detected in 21 percent of unrelated cases - making it one of the most common causes of LCA yet identified. The team's research, which was funded by the Foundation Fighting Blindness Canada, was published in the September 2006 issue of The American Journal of Human Genetics.

Complaint Filed Against PreMD in U.S. Court

Predictive medicine company PreMD Inc. (Toronto) announced that it has been provided with a copy of a complaint filed against PreMD in the United States District Court in Maryland on behalf of Med-11 AG ("Med-11") and Dr. Abulkalam Shamsuddin relating to an alleged breach by PreMD of its 1998 license agreement with Shamsuddin, which is governed by the laws of the Province of Ontario, pursuant to which Shamsuddin granted an exclusive license to PreMD relating to certain intellectual property involving part of PreMD's cancer products, which include ColorectAlert(TM), LungAlert(TM) and a breast cancer test. PreMD has been advised that Shamsuddin has transferred his interest in the technology to Med-11 and that Shamsuddin has also purported to transfer the license agreement to Med-11 without PreMD's consent. In the complaint, Shamsuddin and Med-11 have made unsubstantiated allegations that PreMD is in breach of certain terms of the agreement, all of which are as yet unproven and are denied by PreMD. PreMD is currently reviewing the Complaint and will take appropriate action. http://www.premdinc.com

Neurochem submits a complete response to FDA approvable letter

Neurochem (International) Limited, a wholly-owned subsidiary of Neurochem Inc. (Montreal) announced that it has submitted a complete response to the U.S. Food and Drug Administration's (FDA) August 2006 approvable letter for KIACTA(TM). The Company is seeking marketing approval of its investigational product candidate KIACTA(TM) (eprodisate; formerly FIBRILLEX(TM)) for the treatment of Amyloid A (AA) amyloidosis. Today, there is still no specific treatment for AA amyloidosis, a deadly disease which often destroys kidney function. The complete response includes the data on safety and efficacy from a follow-up of all 183 patients who were enrolled in the Phase II/III clinical trial. Following the suggestion of the FDA in its approvable letter, Neurochem successfully retrieved the most recent health information (i.e. dialysis/end stage renal disease (ESRD) or death from all causes, regardless of when the clinical event occurred) for all 183 study subjects, including patients currently enrolled in the open-label extension study and all patients who discontinued their participation in the study. The median time of follow-up was approximately 36 months. http://www.neurochem.com

Clinical Trials

Novadaq announces initiation of LUNA System human clinical trials

Novadaq(R) Technologies Inc. (Toronto), a developer of medical imaging systems for the operating room, today announced that it has commenced the first human trial with the LUNA(TM) System. Novadaq designed and developed the LUNA System to enable surgeons to visualize nerves, tissue perfusion and lymph nodes during urological applications, including but not limited to, radical prostatectomy surgery. This first trial enrolled and imaged its first patients over the past week at the Strong Memorial Hospital, University of Rochester, Rochester, N.Y., USA. This first application uses the LUNA System to assist the surgeon to evaluate and identify tumor margins in kidney tumors. It is anticipated that successful tumor identification will aid the surgeon in removing as much of the tumor as possible, while preserving normal tissue. The initial images demonstrate the differential perfusion of the tumor to normal tissue allowing the doctor to clearly identify the extent of the tumor, while surgically removing it. The trial is designed to evaluate the clinical utility of the images, as well as correlate the findings to standard histopathology determinations of tumor margins. In addition, LUNA can be used to evaluate perfusion of the kidney after partial nephrectomy, something that is not routinely or practically done in the operating room without the LUNA System. Novadaq intends to initiate further clinical work in radical prostatectomy surgery later this year. http://www.novadaq.com

CryoCath enrolls first patient in U.S. AF trial

CryoCath Technologies (Montreal), the global leader in cryotherapy products to treat cardiovascular disease, announced the first patient has been enrolled and treated in its pivotal Investigational Device (IDE) STOP AF trial. The FDA approved trial is designed to demonstrate Arctic Front(TM)'s clinical and therapeutic effectiveness in treating Atrial Fibrillation (AF). The patient was enrolled by Dr. Kevin Wheelan and treated at the Baylor Medical Center in Dallas, Texas. The procedure was considered an acute success. There were no safety concerns noted, including no reports of phrenic nerve injury, thrombosis, or stroke. http://www.cryocath.com

YM BioSciences announces results of AeroLEF Phase IIb open-label study

YM BioSciences Inc. (Mississauga), a company engaged in the acquisition, development and commercialization of oncology and acute care products, announced results from the open-label portion of its Phase IIb trial (DLXLEF-AP4) of AeroLEF(TM). The results demonstrated that the majority of the patients were able to achieve effective analgesia for episodes of moderate to severe acute post-surgical pain by self-titrating the amount of medication they inhaled using AeroLEF(TM). Results of the study were presented at the American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, IL. AeroLEF is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl, in development for the treatment of moderate to severe pain, including cancer pain. AeroLEF is designed to permit patients to match dosage to their individual pain intensity and experience rapid and extended pain relief. http://www.ymbiosciences.com

Welichem Completed Major Pre-clinical Tests for Psoriasis Drug Candidate

Welichem Biotech Inc. (Burnaby) announced completion, on October 15, 2006, of the 28-day, repeat dermal application study on mini-pigs for the Company's lead drug candidate ("WBI-1001") targeting psoriasis. This was the last major pre-clinical study before the Company files a Clinical Trial Application (CTA) for WBI-1001. Preliminary observations indicate that the study went well and that the animals were in good condition throughout the duration of the study. However, the final results will not be available until completion of the in-depth data analysis. The Company anticipates that the final report on this study will be released in early 2007, and that clinical trials will follow subject to regulatory approval and completion of the next staged financing. http://www.welichem.com

Medical Devices and Diagnostics Update

Victhom Human Bionics Announces The Filing Of A Provisional Patent

Victhom Human Bionics (Quebec City) announced that, after a series of pilot animal studies on potential medical indications of its Closed Loop System (the CLS Neuromodulator), the Company has filed a U.S. provisional patent application entitled "Bio-Interfacing Closed Loop Platform for the Correction of Disorders and/or Deficiencies in a Physiological Process Such as Sleep Apnea", aimed at the management of respiratory disorders such as sleep apnea. "The studies that were conducted demonstrate that our technology is efficient for the recognition of respiratory deficiencies and are an encouraging indication that our CLS Neuromodulator and its components such as the Neurocuff(TM) and the Neurolink(TM) could be developed for several other indications considered as unmet medical needs", mentioned Mr. Stephane Bedard, Founder and Chief Operating Officer. http://www.victhom.com

Industry Briefs

Helix BioPharma Corp. (Aurora) announced the closing of a private placement, for gross proceeds of CDN$7,044,500. Helix issued 3,650,000 units, with each unit consisting of one common share and one common share purchase warrant. Each common share purchase warrant entitles the holder to purchase one common share at a price of $2.70 until March 31, 2008. Helix intends to use the proceeds of this placement to fund research and development for L-DOS47 in addition to working capital and general corporate initiatives. http://www.helixbiopharma.com

Chromos Molecular Systems Inc. (Burnaby) has entered into a bridge loan financing arrangement for $2,000,000 with a syndicate including Pender NDI Life Sciences (VCC) Inc., Pender Growth Fund (VCC) Inc., NeuroDiscovery Limited Partnership and Rix Professional Medical Corporation. The proceeds of the loan will be used to fund operations of Chromos as it seeks additional equity financing. http://www.chromos.com

Atrium Biotechnologies Inc. (Quebec City) completed its previously-announced "bought deal" secondary offering of 3,930,000 subordinate voting shares at a price of C$15.80 per share, for total proceeds to the selling shareholders of C$62 million. http://www.atrium-bio.com

AEterna Zentaris Inc. (Quebec City), a growing global biopharmaceutical company focused on endocrine therapy and oncology, announced that it has closed its previously announced secondary offering of its 3,485,000 subordinate voting shares of Atrium Biotechnologies Inc., at a price of Cdn$15.80 per share. http://www.aeternazentaris.com.

Patheon Inc. (Toronto) announced that it has entered into an agreement with its lenders to amend certain financial covenants under its North American loan facilities. The amendment to the North American credit agreement establishes amended financial covenants, including trailing 12-month debt-to-EBITDA covenants. The amended covenants, to be satisfied monthly, cover a six-month period from October 31, 2006 to March 31, 2007, by which time Patheon intends to have implemented a long-term improvement to its capital structure. http://www.patheon.com

Tm Bioscience Corporation (Toronto), a leader in the commercial genetic testing market, announced that it has amended its license agreement with Sirius Genomics to defer a $2 million license fee payment originally due on September 5, 2006. This payment will now become due in October 2007 or 90 days after completion of certain milestones by Sirius. Amendments related to the delay of the license fee payment have been made to the interest rate calculation used when determining the aggregate amount which Tm is eligible to set off against its Licensee Fee obligations. All other terms of the original license agreement remain in effect unchanged. http://www.tmbioscience.com.

(Life Sciences News Briefs © 2005 is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Louise Leduc Tel: (613) 954-4715; E-mail: Leduc.Louise@ic.gc.ca).