Life Sciences News Brief
Vol. 5 no. 8 - April 6, 2005
　

Procyon Biopharma Inc. (Montreal) reported the first pharmacokinetics results with PPL-100, a phosphorylated pro-drug of its protease inhibitor, PL-100. Initial in vitro study results indicated that PPL-100 is 1000-fold more water-soluble than its precursor, PL-100. More importantly, pharmacokinetics studies conducted in rats showed a two- to three-fold improvement in key pharmacokinetic parameters such as maximum plasma concentration (Cmax) and oral bioavailability compared to PL-100. Plasma levels obtained with PPL-100 in rats suggest that PPL-100's previously-reported broad and favorable cross resistance profile will be supported in a clinical setting by encouraging pharmacokinetics results at this time. Dr. Jinzi J. Wu, Vice President, Preclinical and Basic Research, will present the latest resistance and pharmacokinetic data on PPL-100 at the 6th International Workshop on Clinical Pharmacology of HIV Therapy, on April 28 in Quebec City.

Viventia Biotech Inc. Reports Positive Head & Neck Cancer Results

Viventia Biotech Inc. (Toronto) reported preliminary results from an exploratory Phase I efficacy trial using direct intratumoral injection of Proxinium(TM) as a monotherapy for the treatment of patients with refractory head & neck cancer. A total of 20 patients were enrolled in the study, of which 18 were considered evaluable at the end of the trial. Preliminary efficacy analysis showed that 25% of the 16 evaluable patients who expressed the therapeutic target for Proxinium(TM) had a complete response to therapy (complete disappearance of treated tumor); 63% had an objective response (significant or partial shrinkage of treated tumor); and 88% had tumor growth control (objective response or stabilization of disease). The drug was reported to have a good safety profile and was well-tolerated, consistent with previous results.

Adherex Receives Regulatory Clearance For Phase II Trial Of ADH-1

Adherex Technologies Inc. (Ottawa), a biopharmaceutical company with a broad portfolio of oncology products under development, announced that Health Canada has given regulatory clearance for the Company's Phase II Clinical Trial Application (CTA) for ADH-1, the Company's lead anti-tumor biotechnology compound, also known as Exherin(TM). The Phase II trial, which is expected to involve up to three cancer centers in Canada, will investigate repeated doses of ADH-1 in an every three-week dosing schedule in patients whose tumors express the molecular target N-cadherin. Specifically, the Company will study eight different tumor types, including some more common ones such as breast and lung, as well as some rarer cancers such as adrenocortical and esophageal cancer. This trial, the first in the Company's Phase II program, is expected to enroll up to 60 patients.

Vasogen Research Published in the Journal of Biological Chemistry

Vasogen Inc. (Toronto), a leader in the research and development of immune modulation therapies targeting the chronic inflammation underlying cardiovascular and neurological disorders, announced the publication of preclinical findings demonstrating the ability of VP015, a formulation from its VP series of drugs, to significantly reverse a measure of the impairment of memory and learning function associated with aging. The data also showed that the effects of VP015 cross the blood-brain barrier and provide a neuro-protective effect against inflammation within the brain. The results, which are based on research conducted at the Department of Physiology of Trinity College in Dublin, Ireland, have been published in the Journal of Biological Chemistry in an article describing the role of the cytokine IL-4 in the regulation of age-related inflammatory changes in the brain and the action of VP015 to increase this anti-inflammatory factor.

ARIUS Research Inc. (Toronto) announced that it has entered into research collaboration with Dr. Bianca Wittig of Charité University Medicine, Berlin, to study ARIUS' anti-CD44 antibody ARH460-16-2 in models of inflammatory bowel diseases (IBD). Dr. Wittig has investigated patients with Crohn's disease, a subgroup of inflammatory bowel disease (IBD) and found that a variant of CD44, CD44v7, is essential for intestinal inflammation in Crohn's disease but not for inflammation due to acute infections such as diverticulitis. Furthermore, her research showed that blocking this variant CD44 affects the cells that are responsible for inflammation and will resolve inflammatory infiltrates in mouse models of Crohn's disease. In both experimental colitis and in certain cells of Crohn's disease patients, antibody blockade of CD44v7 induced regulatory cytokine secretion and apoptosis in T cells and macrophages.

AEterna Zentaris Receives First Regulatory Approval for Impavido(R)

AEterna Zentaris Inc. (Quebec City) announced it has received Colombian Food and Drug Agency approval for Impavido(R) (miltefosine), to treat the cutaneous form of leishmaniasis, a severe parasitic skin disease estimated to affect millions of people worldwide. This is the first-ever approval of Impavido(R) for this form of leishmaniasis. The approval also applies for the visceral form (black fever) of leishmaniasis for which Impavido(R) had already received approval by the Indian and German Regulatory Authorities. Impavido(R) thus becomes the first orally administered, breakthrough therapy for both visceral and cutaneous leishmaniasis.

LAB initiates patient enrollment in Phase II Fentanyl TAIFUN(R) trial

LAB International Inc. (Laval), an integrated drug development company focused on the inhalation market, announced that it has initiated patient enrollment for the Phase II trial of its lead product, Fentanyl TAIFUN(R), a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform. The multi-centered, randomized, double blind, placebo controlled phase II trial is investigating the efficacy and safety of Fentanyl TAIFUN(R) for the treatment of breakthrough cancer pain, monitoring response at different Fentanyl doses. The trial is enrolling 112 cancer patients on maintenance opioid therapy for persistent pain.

ID Biomedical Completes Enrollment for Pivotal Fluviral Clinical Trial

ID Biomedical Corporation (Vancouver) announced that it has completed the enrollment of 1,000 subjects for its Fluviral clinical trial intended to support accelerated approval in the United States. As recently announced, the Company expanded this trial from 300 subjects to 1,000 healthy adults from age 18 to 64. This randomized, double blind, comparator-controlled study is designed to evaluate the safety and immunogenicity of Fluviral in healthy adults.

Two-Drug Combo Lessens Chronic Nerve Pain

In a finding that may bring relief to millions, Canadian researchers say a combination of morphine and the analgesic gabapentin better controls chronic nerve pain than either drug alone, and at lower doses. Chronic neuropathic pain -- which includes both shooting and steady pain, as well as numbness and tingling -- can stem from any number of causes, including diabetes, chemotherapy, viral infections such as shingles or HIV and certain forms of back pain, such as sciatica. Overall, experts estimate that 5 million Americans suffer from this type of chronic pain. People tend to rely on increasingly high doses of sedating medications, including morphine, to dull that pain. Many of those people "would rather have a little more pain than have [the] side effects" that accompany mega-doses, explained study lead researcher Dr. Ian Gilron, of Queens University, in Kingston, Ontario.

Biovail Updates Status Of NDA For Tramadol ER

Biovail Corporation (Toronto) announced that it has received comments from the United States Food and Drug Administration (FDA) with regard to its New Drug Application (NDA) for Tramadol ER, an extended-release, once-daily formulation of tramadol hydrochloride. The FDA has acknowledged that Biovail's Complete Response to the Tramadol ER Approvable Letter is a Class 2 response, which is therefore subject to a six-month review. The FDA has also advised that, upon preliminary review, it is of the opinion that additional clinical trial data will be required.

CryoCath Technologies Inc., (Montreal) the global leader in cryotherapy products to treat cardiovascular disease, announced it has received clearance from the United States Food and Drug Administration (FDA) to initiate an Investigational Device Exemption (IDE) study for the treatment of Atrial Fibrillation (AF). The study will see the use of two CryoCath catheters, Arctic Front(TM) to treat AF and Freezor(R) MAX to treat Atrial Flutter when concomitant to AF. The initial stage of this trial will treat approximately 25 AF patients at three U.S. centers, with enrolment completed by the end of the second quarter of calendar 2005. Initial three-month follow-up data is expected to be available in the fourth quarter of calendar 2005. The trial's endpoints will be safety (stenosis) and efficacy (AF free with or without drugs). Following discussions with the FDA, CryoCath intends to use the data from this initial stage of the trial and ongoing European data to apply for U.S. regulatory approval to commence the pivotal stage of this IDE study for the treatment of AF.

• Baxter Healthcare Corporation and Cangene Corporation (Winnipeg) announced that, effective immediately, Baxter has assumed exclusive rights to market and distribute Cangene's WinRho(R) SDF [Rho(D) Immune Globulin Intravenous (Human)] in the United States. WinRho SDF is used to treat a critical bleeding disorder called immune thrombocytopenic purpura (ITP). Baxter currently markets WinRho SDF for Cangene in the United Kingdom and intends to launch the therapy in 10 other European countries…..
• AEterna Zentaris Inc. (Quebec City) announced that its 61.1%-owned subsidiary, Atrium Biotechnologies Inc. has filed a final prospectus with the securities regulatory authorities in each of the provinces of Canada in connection with an initial public offering and secondary offering of 6,250,000 subordinate voting shares at a price of $12 per share, for total proceeds of $75 million…….
• Paladin Labs Inc. (Montreal) announced the appointment of Dr. Patrice Larose as Vice-President, Regulatory Affairs, Drug Safety and Medical Services. Dr. Larose will join Paladin on April 4, 2005…….
• Bioniche Life Sciences Inc. (Belleville), announced that it has had an additional European patent granted by the European Patent Office (EPO) on its core mycobacterial cell wall technology……..
• DiagnoCure Inc. (Quebec City), announced that it received yesterday the 2005 Genesis Award in the category of Entrepreneurship /Biotechnology /Biopharmaceutical during the 5th annual Genesis Awards ceremony in Montreal…..
• AnorMED Inc.(Vancouver) announced that it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration for approval to begin its clinical program for AMD3100 in cardiac patients. The filing is the first step in evaluating the potential of AMD3100, a stem cell mobilizer, to help repair damaged heart tissue in patients who have suffered heart attacks……
• Hemosol Corp. (Toronto) announced that it has successfully implemented the novel Cascade technology for the extraction of valuable therapeutic plasma proteins at a 30-litre scale. Hemosol has met or exceeded yield expectations and demonstrated significant improvement over existing manufacturing methods. The achievement of these milestones will allow Hemosol to move to clinical scale production later in the year……
• Dimethaid Research Inc. (Toronto) has received an update from the Patented Medicine Prices Review Board (PMPRB) on the previously disclosed review of Pennsaid pricing in Canada. Under the review, the PMPRB has initially determined that the price of Pennsaid in Canada exceeds pricing guidelines. On the basis of this determination, the PMPRB has identified excess revenues owing in the amount of $4.5 million Cdn from the product launch in March 2003 to December 2004. A further $1.1 million Cdn may be determined owing from January 2005 until May 3, 2005, when the company's patent for Pennsaid in Canada expires. At the time of patent expiration, the PMPRB no longer has the authority to regulate Pennsaid pricing in Canada…..
• DiagnoCure Inc. (Quebec City) announced that Mr. Paul Gobeil was elected to the Board of Directors at the Annual Shareholders' meeting held in Montreal and was subsequently appointed as Chairman of the Board of Directors of the Company. ….
• MedMira Inc., (Halifax) announced that it has successfully upgraded its quality management system to the ISO 13485:2003 standard; the highest standard of quality in medical device manufacturing. This new standard is formally recognized by the European Commission as a key quality assurance requirement for CE Mark approval of medical devices, such as the rapid HIV test, for the European Union (EU)….
• Genomics One Corporation (Laval) announced that it had signed a co-development and co-distribution agreement in the field of Mass Spectrometry with ABIONIX S.a.r.l., a Company based in France. The Corporation also announced that it has entered into a financing agreement with Swiss-based Capital Système Investissements (CSI).

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