Ottawa, ON – May 18, 2004 – The following life sciences news briefs were recently published by Industry Canada.
1) Pharmaceuticals Update
Vasogen’s VP025 reduces brain injury in preclinical model
Vasogen (Mississauga) announced that preclinical findings demonstrating the ability of the company’s phospholipid-based drug, VP025, to reduce perinatal hypoxic-ischemic brain injury. Perinatal hypoxic-ischemic brain injury is accompanied by an inflammatory response that contributes to brain degeneration (atrophy). In the study, rat pups were treated with either VP025 or saline, and then exposed to a severe hypoxic-ischemic insult that damages the right cerebral hemisphere. Two investigators, blind to treatment, categorized brain damage based on gross injury and the severity of brain atrophy. The administration of VP025 resulted in significantly lower categories of brain injury compared to saline-treated controls (p equals 0.0002). An assessment of gross injury showed that 43.2% of saline-treated rats displayed cavitary brain lesions compared with only 7.1% in the group treated with VP025. A quantitative assessment of the right hemisphere showed that VP025 reduced brain atrophy by half, with average atrophy of 33.6% for the saline-treated group, compared to 16.8% for the group treated with VP025 (p less than 0.001).
Lorus announces initiation of colon cancer trial with GTI-2040
Lorus Therapeutics (Toronto) announced the initiation of a clinical trial of GTI-2040 in a novel combination with oxaliplatin and capecitabine in patients with advanced unresectable colon cancer. This new study is under the direction of Dr Stephen Shibata at the City of Hope Comprehensive Cancer Center in Duarte California, together with Dr Heinz-Joseph Lenz at the University of Southern California in Los Angeles, Dr David Gandara at the Davis Cancer Center, University of California in Sacramento and Dr Mark McNamara at the City of Hope Medical Group in Pasadena. A key objective of this clinical study is to establish the optimal dose of this combination in colon cancer patients and the pharmacodynamic effects on cellular markers of anti-tumor activity when these agents are combined. This trial is one of six clinical studies in a Phase II clinical program for GTI-2040 in combination with other agents and in various tumor.
ConjuChem starts Phase I Trial for DAC:GRF in the US
ConjuChem (Montreal) announced that it received clearance from the US Food and Drug Administration to begin a Phase I clinical trial in the United States with its proprietary DAC:GRF compound for the treatment of growth hormone deficiency in children and adults. This study is being conducted at a major healthcare centre in Florida that has extensive expertise in conducting Phase I programs. The study will enroll a maximum of 48 subjects in six ascending dose cohorts of six subjects each (five on drug, one placebo) followed by one group of twelve subjects administered the maximum tolerated dose (MTD) (ten on drug, two placebo) as determined by the results of the earlier cohorts. Each subject will receive a single subcutaneous (SC) dose of DAC:GRF or placebo. The primary endpoint for this study is to assess the compound’s safety and tolerability; secondary endpoints will measure the pharmacokinetic and pharmacodynamic profiles of the compound based on an assessment of the growth hormone (GH) and insulin-like growth factor-1 (IGF-1) plasma levels.
2) Diagnostics and Therapeutics Update
MDS announces completion of Hemosol transaction
MDS (Toronto) announced the completion of its reorganization transaction with Hemosol. Under the terms of the transaction, MDS transferred its Ontario lab business to Hemosol and substantially all of the assets and liabilities of Hemosol were transferred to a new company of a similar name, which will continue researching and developing blood products. The transaction provided Hemosol’s business with approximately $16 million in cash and other consideration and will allow MDS to benefit from Hemosol’s unused tax assets. MDS estimates the present value benefit of the transaction to be approximately $55 million to $60 million, which will be realized over the next several years.
Theratechnologies: preliminary Phase I results for ThPTH
Theratechnologies (Montreal) announced positive preliminary results of a Phase I clinical study for ThPTH, its transdermal formulation of parathyroid hormone (PTH) being developed in collaboration with ALZA of Mountain View, CA for the treatment of osteoporosis. The study showed that delivery of ThPTH using ALZA’s Macroflux technology allows for rapid delivery of PTH, good bioavailability, biologic activity of PTH and a good safety profile. The preliminary results indicate that the Macroflux-PTH patch delivered PTH, as measured by ELISA, at blood levels in the range of that obtained with sc administration. Urinary cyclic AMP levels (cAMP), a known marker of PTH’s biological activity, were monitored in this study. After adjusting for the glomerular filtration, the calculated glomerular filtrate cAMP concentration increased markedly within two hours for both routes of administration. Changes were also observed for both routes of administration in other markers of PTH’s biological activity, such as serum calcium. There were no serious adverse events reported for the Macroflux-PTH treatment group. The majority of the systemic adverse events observed in both treatment groups are typical of what has been previously reported.
Iatra to form joint venture with P2P Health Systems
Iatra Life Sciences (Toronto) announced that it has signed a letter of intent with P2P Health Systems (Halifax) to form a joint venture to develop and commercialize P2P’s telehealth, telemonitoring and diagnostic telemedicine technologies worldwide. Iatra will contribute funding of $2 million to the joint venture in agreed tranches, and provide marketing, sales, administrative and management support. P2P’s contributions to the joint venture will be its technology systems, patient information systems and intellectual property. P2P will further provide research and development, product development, customer support, administrative and management functions. P2P offers healthcare providers a full range of integrated telehealth solutions, fully supported by a patient information system that is web accessible.
Cardiome continuation of Phase 3 atrial arrhythmia trial
Cardiome Pharma Corp (Vancouver) announced that its independent data safety monitoring board (DSMB) has issued a recommendation to continue the Phase 3 clinical trial, ACT 1, evaluating intravenous RSD1235 as a treatment for acute atrial fibrillation and atrial flutter. The DSMB found no safety concerns that would require protocol changes and recommended that the trial continue.
Isotechnika submits clinical trial application for TAFA-93
Isotechnika (Edmonton) announced that the company has submitted a clinical trial application to Health Canada for the commencement of Phase I human clinical trials for TAFA-93. TAFA-93 is a novel prodrug of the mTOR inhibitor Rapamycin. TAFA-93 has been designed to reduce the unfavorable pharmacokinetics and side effects of Rapamycin. mTOR inhibitors are currently used in the prevention of organ rejection in transplantation, in the treatment of autoimmune and oncological diseases, and as a component of coated stents for the treatment of coronary artery disease. The mechanism of action of TAFA-93 is distinct from calcineurin inhibitors such as ISA247, Isotechnika’s lead drug. Therefore, TAFA-93 has the potential to be administered as a complimentary therapy along with ISA247 in the prevention of organ rejection after transplantation.
3) Medical Devices
Pheromone sells worldwide marketing rights to its Fertiliti-OV
Pheromone Sciences (Toronto), a biotech company specializing in the field of ovulation detection, announces the signing of a definitive agreement pursuant to which Healthwatchsystems, a privately he
ld company based in Sarasota, FL, will take over the worldwide marketing of Pheromone’s proprietary technology, the Fertiliti-OV fertility monitor and accompanying technology. As part of the transaction, Healthwatchsystems will acquire the patents related to this technology. Pheromone will receive $500,000, payable on closing, and a graduated royalty on world wide sales of the fertility monitor and any related products stemming from this technology until the earlier of the expiration of the patents or 2014.
CryoCath’s FrostByte receives FDA clearance, company poised to launch
CryoCath Technologies (Montreal), the world leader in cryotherapy products for the treatment of cardiovascular disease, announced that it has received 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for FrostByte, a clamp ablation device to be used in the treatment of cardiac arrhythmias. The company expects to receive CE Mark shortly, and launch the product in June 2004.
ART announces positive clinical study results
ART Advanced Research Technologies (Montreal), which develops optical molecular imaging products for the healthcare and pharmaceutical industries, announced at Biomedex 2004 positive clinical study results from product research and development with ART’s SoftScan breast imaging system. Those results confirm SoftScan’s ability to discriminate between normal and malignant tissue. Dr David Fleiszer, co-director of the Cedars Breast Clinic of the McGill University Health Centre (MUHC) and principal investigator of the study, commented: “These results further demonstrate that the SoftScan breast imaging system is promising in its ability to discriminate between malignant and benign breast lesions." Micheline Bouchard, president and CEO of ART, said: "These results show that our SoftScan time-domain optical breast imaging device has the potential to radically transform how breast cancer is diagnosed and treated – and ultimately to significantly reduce the level of anxiety, pain and loss women experience.”
4) Industry Update
MedMira (Halifax) announced that the company has signed representation agreements for countries in Central America, Eastern Europe and Africa for sales of the MiraWell Rapid HIV-1 Test kits with established international medical device marketing group, US based Royale Medical International, to develop existing opportunities in Colombia, Moldova and Nigeria.
ART Advanced Research Technologies (Montreal) says it received the Health Technology Entrepreneurship Award at the 4th Genesis Awards held on Thursday, April 29.
The awards pay tribute to the people and companies that play a crucial role in the growth of Quebec’s biotechnology, health technology and life sciences industries.
In its recent study, entitled US Breast Cancer Therapeutics Market, Frost & Sullivan found that YM BioSciences (Missisauga) is the entrepreneurial leader in developing its novel late-stage cytotoxic-enhancing compound, which will potentially enhance tactics to fight the continuing war against cancer.
TSO3 (Quebec City) announced the signing of five additional agreements with referral sites in the US, including four with major hospitals and one with an industrial customer. These new agreements were negotiated in collaboration with Skytron, the distribution partner of TSO3, and are in addition to the those previously announced, bringing the number of technological showcases for the 125L Ozone Sterilizer in the US to seven.
Labopharm (Laval) announced that it has entered into an agreement to issue 6,122,449 common shares on a bought deal basis to a syndicate of underwriters co-led by Desjardins Securities and RBC Capital Markets. The syndicate will also include National Bank Financial, Canaccord Capital, and GMP Securities.
AlphaRx (Markham) announced that in preparation of entering clinical trials for Indaflex, they have appointed Parexel International, a leading contract research organization, to assist in the planning and execution of those trials.
Ondine Biopharma (Vancouver) announced that Douglass Watson and Terence (Terry) Holland have been appointed to the board of directors of the company.
MedMira (Halifax) announced that its founder and chief operating officer, Mr Hermes Chan, was this year’s recipient of the prestigious award for research excellence presented by BioNova, Nova Scotia’s biotechnology industry association.
Procyon Biopharma (Montreal) announced that it received two prestigious awards at the 2004 Genesis Ceremony held in Montreal during the Annual Biomedex Conference. The first award, “Entrepreneurship – Biotechnology-Biopharmaceutical”, a tribute from the Fonds de Solidariti de la FTQ, recognized Procyon’s growth in terms of personnel and investments and its management team for its growth-oriented management style and leadership in developing its products. Procyon’s President and Chief Executive Officer, Mr Hans J Mader, also received the “Brio” award, a tribute from the Royal Bank of Canada, which salutes his significant contribution to the development of the biotechnology and lifesciences industries.
Life Sciences News Briefs 2004 is prepared by Armar International for the Life Sciences Branch of Industry Canada (contact: Sandy Vien; Tel: 613-941-6479; E-mail: firstname.lastname@example.org).