www.laboratoryfocus.ca
Laboratory Focus August/September 2014
Pharma notes OncoGenex Pharmaceuticals, Inc. (Vancouver, BC) says that its Cedar™ clinical trial, an investigatorsponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer is now open for enrollment. Apatorsen is a once-weekly intravenous (IV) experimental drug that is designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells’ defenses and overcome treatment resistance. Approximately 140 patients with previously untreated stage IV or recurrent squamous cell lung cancers or stage IIIB squamous cell cancers that are not amenable to radiochemotherapy will be randomized to receive either apatorsen plus gemcitabine and carboplatin therapy, or gemcitabine and carboplatin therapy alone. The primary objective of the study is progression-free survival (PFS), with secondary objectives to evaluate tumour response rates, overall survival, safety, tolerability and health-related quality of life. Additional analyses will be conducted to determine the effect of therapy on Hsp27 levels and to explore potential biomarkers that may help predict response to treatment. Biosign Technologies Inc. (Thornhill, ON) has completed its acquisition of 51 per cent of issued and outstanding shares of Meck Medical GmbH (MECK). In connection with the acquisition, the company has agreed to provide MECK a loan to fund its operations of up to 100,000 Euros per month to a maximum of 2.4 million Euros in the aggregate. Specialty pharmaceutical company Medicure Inc. (Winnipeg, MB) through its newly formed subsidiary, Medicure U.S.A. Inc. has acquired a minority interest in pharmaceutical manufacturing business Apicore (Somerset, NJ). In all, Medicure and Medicure USA have acquired a 6.09 per cent equity interest (5.33 per
cent on a fully-diluted basis) in two newly formed holding companies of which Apicore LLC and Apicore US LLC will be wholly owned operating subsidiaries. Medicure has also received an option to acquire all of the remaining issued shares of Apicore LLC and the holding company of Apicore US LLC, within the next three years. Eventi Capital Partners, a Toronto-based growth capital investment firm specializing in high growth technologies in the IT and healthcare sectors, has sold Visualase Inc. (Houston,TX) to Medtronic Inc. in a deal valuing the company at approximately US$105 million. Visualase develops and sells a laser system for minimally invasive neurosurgery. The Visualase technology has been used to treat more than 800 neurosurgical patients. Eventi Capital Partners made its initial investment in Visualase in February 2009 with a follow-on round of financing made in May 2012. The all-cash transaction of up to US$105 million includes an initial payment of US$70 million to Visualase’s shareholders plus the potential for an additional US$35 million in incremental revenue-based earn out payments. Leerink Partners LLC served as financial advisor and Miller, Egan, Molter & Nelson LLP served as legal advisor in the transaction.
Privately owned Canadian pharmaceutical services provider Dalton Pharma Services (Toronto, ON) has entered into a manufacturing services agreement with GLyPharma Therapeutics Inc., a Montréal-based company developing clinical therapies for chemotherapyinduced intestinal mucositis. Under the terms of the service agreement Dalton Pharma Services will provide aseptic fill/finish services and analytical support under cGMP for FE 203799, a long-acting GLP-2 receptor agonist under development by GLyPharma as a therapy for supportive care in oncology for patients receiving chemotherapy. Laval-based KLOX Technologies has struck a license and joint venture agreement deal with dermatology company LEO Pharma to further develop and commercialize KLOX’s BioPhotonic technology platform in dermatology, which includes the LumiCleanse System. The worldwide license and joint venture agreement, excludes Canada where KLOX’s solution is commercialized by Sandoz Canada. Additionally, as part of the agreement LEO Pharma says it will also make an equity investment in KLOX. Toronto, ON-based Lorus Therapeutics says the FDA has completed its review and cleared the company’s
investigational-new-drug application of LOR-253 for the treatment of hematologic malignancies, including acute myeloid leukemia, high-risk myelodysplastic syndromes, lymphomas and multiple myeloma. Clearance of the IND allows Lorus to initiate a Phase 1b, multicenter, open-label, clinical study of LOR-253 in patients with relapsed or refractory hematologic malignancies. The Phase 1b trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamic responses and efficacy of LOR-253 as a single agent. The trial is expected to enroll 45-to-60 patients as part of a dose-escalation program and two separate disease-specific single-agent expansion cohorts. Lorus believes that LOR-253 may represent a targeted therapeutic solution for a very difficult-to-treat cancer. It works by inducing the KLF4 gene, which has been reported as a key transforming event in AML and high-risk MDS. Amorfix Life Sciences (Mississauga, ON) has been issued a broad patent covering antibodies that target misfolded SOD1 (mSOD1) for the treatment of ALS. The patent has issued as US 8,778,885. SOD1 is a protein which is highly expressed in the motor nerve cells which degenerate in ALS. While normally a protector of cells, under certain conditions it can “misfold” – its
&
7
three-dimensional structure becomes distorted – and it then becomes toxic for cells, as well as triggering propagated misfolding of normal SOD1. This mechanism of disease onset and progression scould support mSOD1 as a target for the development of therapeutics for the treatment of ALS. ProMetic Life Sciences Inc. (Laval, QC) reports that it has successfully completed its PBI-4050 Phase 1 clinical trial in 40 healthy volunteers and that PBI-4050 was found to be safe and very well tolerated without any serious adverse events reported in any of the five cohorts tested. The objectives of the oral, double blind, placebo controlled, single ascending dose study were to demonstrate the safety and tolerability of PBI-4050 and to establish the pharmacokinetic profile of the drug candidate at different doses. The study design also included a component looking at food effect on drug absorption. The trial was conducted in five cohorts of eight subjects. In each cohort, six subjects received PBI-4050 and two subjects received matching placebo. ProMetic added that PBI-4050 is now set to move into clinical development in diabetic patients with kidney diseases, as well as other orphan medical conditions where diabetes and/or fibrosis is affecting key organs such as liver, kidney, heart and lungs.
Your New Life Science Partners
• Yeast and Bacteria Culture Media • Biological Buffers & Buffer Solutions • Amino Acids & Derivatives
call: 877-225-3366 fax: 905-877-6666 service@caledonlabs.com
