HAIFA, Israel, May 13, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) agreed with the proposed quality and large-scale manufacturing methods for PLX-PAD cells for use in clinical trials. This agreement is an important milestone for initiation of a Phase I/II study in critical limb ischemia through Japan’s Accelerated Pathway for Regenerative Medicine. The new regulatory pathway could potentially significantly reduce time to market for cell therapies such as PLX cells.

“Pluristem is emerging as an early leader in the industry’s push to enter Japan’s newly established accelerated regulatory pathway. It is our hope that the PDMA will approve our application for a Phase I/II clinical study of PLX cells in critical limb ischemia via the Accelerated Pathway,” stated Pluristem CEO Zami Aberman.

Japan’s Accelerated Pathway for Regenerative Medicine went into effect in November 2014. According to the law, regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and initial proof of efficacy. Safety and effectiveness need to be confirmed within 7 years after the conditional approval.

PETACH TIKVA, Israel, May 11, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today announced it recently received clearance from the European Medicines Agency to commence dosing patients in Europe in its global Phase II trial for CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. Shortly after receiving approval, the first patient in Europe was dosed.

The Phase II randomized, double-blind, placebo controlled trial is being conducted in the U.S., Israel, and Europe. The trial protocol has been approved by regulatory agencies in all three regions and patients have been dosed in Israel and Europe. The study plans to enroll 78 HCC patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). Patients are treated twice daily with 25 mg of CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

CF102 has already been granted Orphan Drug Status for the treatment of HCC by the FDA. CF102 is also approved for Compassionate Use by Israel’s Ministry of Health.

“There are no treatment options for patients with advanced liver cancer who have not benefitted from treatment with Nexavar, the only FDA-approved drug on the market for this indication. As patients, who have virtually no other options, are being dosed with CF102, it is certainly our hope that the drug will be of benefit to them,” stated Can-Fite CEO Dr. Pnina Fishman.

According to Global Industry Analysts, the global market for liver cancer is projected to exceed $2 billion in 2015. Based on data reported in industry publications, Nexavar annual sales were approximately $1 billion in 2012 and 2013.

CAESAREA, Israel, May 14, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, has announced today that it has been granted Health Canada approval to market and sell Dario™ in Canada through their exclusive distributor in Canada Auto Control Medical Inc. (“ACM”). ACM is a Canadian leader in the category of medical devices for home use, and has successfully launched several blood glucose monitoring systems into the Canadian market over the years. Health Canada is Canada’s federal department responsible for helping Canadians maintain their health and the Health Canada approval is a major milestone representing the first sales of Dario in North America.

“Health Canada approval marks an important next step as we continue to expand the geographic reach of the Dario Diabetes Management Solution to the world’s huge population of people with Diabetes in order to help make their lives simpler while treating their chronic condition,” said Erez Raphael LabStyle Innovations President and Chief Executive Officer. “We are confident that Dario will be well received in North America as it has been in Europe and we are moving forward towards clearing FDA approval for Dario in the U.S.”

“We are very pleased to be the exclusive distributor of Dario™ in Canada and will begin aggressively marketing it immediately,” said Mr. Robert Burgy, ACM’s President. It is reported that an astonishing number of over 20 people every hour of every day are diagnosed with diabetes in Canada, and it is estimated that there are approximately two million Canadian diabetics, 10% of them with Type 1 diabetes. “We believe that both patients and physicians stand to benefit from Dario’s unique features. It is anticipated that patients will welcome a better understanding of their chronic condition and self-management as a means to thrive with diabetes, while physicians and caregivers will appreciate the ability to facilitate clinical decisions through quick, easy and effective intervention.”

The Company previously announced that it has completed and submitted the submission for FDA review with the results from the successful clinical study performed in the US. The study results showed that the Dario™ Blood Glucose Monitoring System is highly comparable to its predicate device and in fact surpassed other glucose meters. Dario delivers accuracy that exceeds the minimum new stringent guidance of the.