Life sciences news briefs (April 12, 2004)

Ottawa, ON – April 12, 2004 – The following life sciences news briefs were published recently by Industry Canada:

1) Pharmaceuticals Update

Axcan receives European approval of Photobarr

Axcan Pharma (Mont St Hilaire) announced that the committee of proprietary medicinal products of the European Agency for the Evaluation of Medicinal Products has granted Axcan a marketing authorization for use in the European Union of its photodynamic therapy (PDT), Photobarr (porfimer sodium), in the ablation of high-grade dysplasia associated with Barrett’s esophagus. Photobarr PDT was also granted an orphan medical product status at the time of its submission, which guarantees Axcan exclusive marketing rights for Photobarr PDT in the European Union for a ten-year period.

Lorus Therapeutics presents scientific results for two anti-cancer drugs

Lorus Therapeutics (Toronto) announced it participated at the AACR Annual Conference in Orlando, Florida, on March 27-31, 2004. Two presentations were accepted and will be published in the meeting proceedings. The first presentation, entitled Virulizin Increases Infiltration of NK Cells to Tumors Via Activation of Macrophages, summarizes the latest studies on the mechanism by which Virulizin acts as an anti-tumor agent. The aim of the study was to determine whether a subset of immune effector cells known as NK cells contribute to the observed anti-tumor efficacy ofVirulizin. Analysis of tumor samples from Virulizin-treated mice showed an increase in the presence of both macrophages and NK cells within the tumor tissue as compared to tumor tissue from saline-treated mice. This response appeared to occur early in the treatment cycle and correlated with increased markers for programmed cell death within the tumors. Removal of macrophages from mice resulted in decreased numbers of NK cells in tumor samples, indicating the crucial involvement of macrophages in NK cell infiltration into tumors.

AEterna subsidiary Zentaris reports positive preclinical results

AEterna Laboratories (Quebec City) and its subsidiary Zentaris report that positive preclinical results of their novel tubulin-inhibitor ZEN-014 were presented earlier today at the American Association for Cancer Research (AACR) meeting in Orlando, Florida. ZEN-014 is a novel pyrazole derivative that was discovered by Zentaris. It represents a new class of small molecule tubulin binders with antiangiogenic properties which are assumed to be novel highly potent anticancer drugs with blockbuster potential. ZEN-014 inhibits tubulin polymerization with an IC50 of 1.3 (micro)M. The treatment with non-toxic concentrations (10 nM) of ZEN-014 inhibits endothelial cell sprouting and vessel formation. Cancer cells (KB/HeLa) were arrested completely in the G2M phase of mitosis at nanomolar concentrations (IC50: 34 nM) and subsequently underwent apoptosis. Several apoptotic parameters as cell membrane alterations, increase of caspase 3 and 7 activity, DNA fragmentation and inactivation of the Bcl-2 protein are detectable in U937 cancer cells after treatment with nanomolar concentrations of ZEN-014. The compound shows an excellent antitumor activity profile in a broad panel of tumor cell lines (average IC50 of 40 nM) including paclitaxel and vincristine resistant cells. ZEN-014 exhibits promising in vivo activity in a renal cell carcinoma model at a dose of 50 mg/kg after oral application.

2) Diagnostics and Therapeutics Update

Bioniche announces results of Phase I prostate cancer study

At the 19th annual Congress of the European Association of Urology in Vienna, Bioniche Life Sciences (Belleville) announced the results of its Phase I clinical study in prostate cancer using MCC/HA. MCC/HA is a new proprietary formulation of MCC combining mycobacterial cell wall-DNA complex (MCC) and hyaluronic acid (HA). Bioniche has an extensive patent portfolio on the MCC and HA technology platforms. Previous peer-reviewed scientific publications demonstrated that (1) MCC has a dual anti-cancer mode of action by inducing apoptosis in cancer cells as well as stimulating the immune system, and (2) in prostate cancer, the effectiveness of MCC was increased by the presence of HA. Twelve patients with localized prostate cancer and scheduled for radical prostatectomy were enrolled in this Phase I study. The objective of the study was to assess the feasibility and safety of intraprostatic injection of MCC/HA. Patients were injected with MCC/HA into the prostate in a dose escalation manner; four groups of three patients received 100, 200, 400 or 800 mcg followed by prostatectomy.

Aegera initiates Phase 1 oncology clinical trial of XIAP antisense

Aegera Therapeutics (Montreal) announced the initiation of Phase 1 clinical trials for AEG35156/GEM640, an antisense inhibitor of X-linked inhibitor of apoptosis protein (XIAP), in collaboration with Cancer Research UK. AEG35156 is a 2nd generation antisense oligonucleotide, which is designed to reduce high levels of XIAP protein in cancer cells and thereby enable apoptotic cell death. The first patient was enrolled at the Christie Hospital in Manchester by principal investigator, Dr Malcolm Ranson, MBChB, PhD, director of the Derek Crowther Trials Unit. The trial is also being conducted at a second site, Cancer Research UK oncology unit within the University of Edinburgh Cancer Research Centre, under the supervision of Dr Duncan Jodrell, DM.

AnorMED initiates fifth Phase II trial in cancer patients

AnorMED (Vancouver) announced the initiation of its fifth Phase II clinical trial to evaluate AMD3100 as a new stem cell transplantation drug candidate for cancer patients. Clinical data to date in cancer patients shows AMD3100 effectively increases the number of stem cells available for transplantation. The strongest predictor of success in stem cell transplant is the number of stem cells available for transplantation. This is a Phase II trial to optimize the schedule for administering AMD3100 in combination with the standard agent, granulocyte-colony stimulating factor (G-CSF), prior to collection of stem cells for transplantation. In this study patients will be administered AMD3100 at 10 pm and have their stem cells collected at 8 am the next morning. The study will be conducted at multiple centers in the United States and will enroll up to 30 non-Hodgkin’s lymphoma and multiple myeloma patients.

YM BioSciences doses first patient in pivotal breast cancer study

YM BioSciences (Mississauga), the cancer drug development company, announced that the first patient has been dosed in its 700 patient Phase III registration trial. The international pivotal trial is designed to compare the overall survival differential resulting from the combination of YM’s drug, tesmilifene, with the anthracycline, epirubicin, and cyclophosphamide against the use of epirubicin/cyclophosphamide alone in women with metastatic breast cancer.

3) Medical Devices

Cardiome initiates cardiac surgery clinical study

Cardiome Pharma (Vancouver) announced that it has commenced its second Phase 3 efficacy study of RSD1235 for the acute treatment of atrial fibrillation (AF). The study, called ACT 2, will evaluate the efficacy and safety of intravenous RSD1235 for the treatment of patients who have developed transient atrial fibrillation following cardiac surgery. ACT 2 is the second of an expected three Phase 3 clinical studies that Cardiome and its marketing partner Fujisawa Healthcare will undertake prior to filing for approval in the US.

MDS Nordion announces first North American sales of Raycell X-ray

The Indiana Blood Center in Indianapolis, Indiana, and SMDC Laboratory in Duluth, Minnesota have both chosen to purchase MDS Nordion’s (Ottawa) Raycell blood irradiator as a means of eliminating delays in receiving irradiated blood and blood products from external suppliers and improving the service they provide to physicians and patients. The ability to irradiate blood and blood products in-house is a key fact
or in providing better patient care. The MDS Nordion Raycell x-ray blood irradiator is a convenient and cost-effective choice for lower volume hospitals and blood centers looking to establish blood and blood product irradiation services in-house rather than use outside services.

ART announces high sensitivity in small animal imaging data

Advanced Research Technologies (Montreal), a leading developer of optical imaging technologies, announced the presentation of data at the 2004 Annual Meeting of the American Association for Cancer Research held in Orlando, Florida , from in vivo research and development studies with ART’s explore Optix time-domain small animal molecular imaging system. The studies were conducted at LAB Preclinical Research International in Laval, Canada, and at ART by both ART researchers and external investigators. Laura McIntosh, PhD, program director, small animal molecular imaging at ART presented the results of the in vivo studies on Sunday, March 28 in abstract and poster number 222. Consistent with the results of previous studies demonstrating the high quantitation and high sensitivity capabilities of ART’s eXplore Optix time-domain small animal molecular imaging system in the nanomolar range, these in vivo studies demonstrated subnanomole fluorophore quantity detection capabilities at a depth of between 10 and 15 mm. Furthermore, volumetric reconstruction of this time-domain data was also achieved.

4) Industry Update

AEterna Laboratories (Quebec City) announced that its board of directors has adopted a shareholder rights plan, which takes effect immediately. The objectives of the rights plan are to provide adequate time for the corporation’s board of directors and shareholders to assess an unsolicited takeover bid for the corporation, to provide the board of directors with sufficient time to explore and develop alternatives for maximizing shareholder value if a takeover bid is made, and to provide shareholders with an equal opportunity to participate in a takeover bid.

Bioxel Pharma (Sainte Foy), a manufacturer of naturally derived taxanes and targeted oncology drugs, announced that it has extended a non-exclusive purchase agreement for cGMP paclitaxel with Cell Therapeutics, of Seattle, WA.

Oncolytics Biotech (Calgary) announced the appointment of Jim Dinning to the board of directors.

Chromos Molecular Systems (Burnaby) announced that it has extended its collaboration agreement with Lonza Biologics of Slough, England. This agreement provides Lonza researchers with non-exclusive access to Chromos’ ACE System for evaluation in its contract manufacturing business.

YM BioSciences (Mississauga), the cancer drug development company, announced that Dr Kathleen Pritchard, MD, FRCPC, has agreed to act as the North American chair for the company’s upcoming international pivotal DEC study in patients with metastatic breast cancer.

Spectral Diagnostics (Toronto) and IDx are joining in a $12-million three-year project to develop quick diagnostic tests for diseases including West Nile virus. The project is supported by a $3.9-million investment from the federal Industry Ministry’s Technology Partnerships Canada.

Angiotech Pharmaceuticals (Vancouver) announced that its corporate partner, Boston Scientific, concluded enrollment in its Taxus V de novo lesion clinical trial.

Andromed (Montreal), a medical technology company, announces that it has signed a three-year agreement with Prestige Medical, to supply its electronic stethoscope stethos model which Prestige will market under the i-Scope brand name.

Labopharm (Laval) announced that, through its wholly owned subsidiary, Labopharm Europe, it has secured a licensing and distribution agreement for Germany with Hexal for its lead in-house product candidate, a once-daily formulation of tramadol.

Biopharmaceutical company QLT (Vancouver) won approval to acquire privately held Kinetek Pharmaceuticals and said it expects the deal will boost its earnings for the fiscal year.

QLT also reported that the US District Court for the Southern District of New York has entered an order in favor of QLT dismissing with prejudice the consolidated securities class action complaint which was commenced in 2001 against QLT, Dr Julia Levy and Kenneth Galbraith.

Biomira (Edmonton) and Merck of Darmstadt, Germany, said preliminary results from a randomized, open-label Phase IIb trial of BLP25 liposomal vaccine (LBLP25) in patients with Stage IIIb and IV non-small cell lung cancer (NSCLC) indicate that the median survival of those patients on the vaccine arm was 4.4 months longer than those on the control arm. Although not statistically significant, the overall median survival is 17.4 months for patients on the vaccine arm versus 13 months for the patients on the control arm.

Belgium pharma company Solvay announced an $8 million upgrade of its Canadian production facility, Canlac (Victoriaville).

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).