PETACH TIKVA, Israel, March 18, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, announced today it has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR). The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite’s drugs, which are currently in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.

A3AR is present in high concentrations in inflammatory cells and cancer cells. Can-Fite’s proprietary drugs target and bind to A3AR, causing cancer and inflammatory cell apoptosis (programmed cell death). This creates a targeted anti-cancer and anti-inflammatory effect, while leaving normal cells unharmed. Identifying patients with elevated A3AR levels would indicate which patients would benefit most from Can-Fite’s drugs, thereby offering personalized medicine.

“The completion of the development of our commercial A3AR biomarker test kit comes at a very important time since we plan to use the test kit in our upcoming advanced clinical studies. We believe the test kit will create efficiencies in our trials in patient enrollment and monitoring. As we progress into late-stage clinical trials for CF101 in auto-immune diseases, our A3AR biomarker test kit is ready for wide-scale use to help doctors and their patients identify who will be most responsive to Can-Fite’s drugs. We believe these patients can significantly benefit from personalized medicine due to the high degree of clinical heterogeneity,” stated Can-Fite CEO Dr. Pnina Fishman.

The U.S. Patent and Trademark Office issued Can-Fite a patent for the utilization of A3AR as a biomarker to predict patient response to its drug CF101 in autoimmune inflammatory indications. In December 2013, Can Fite reported favorable results from its Phase IIb rheumatoid arthritis clinical trial for CF101, an A3AR agonist. Only patients with elevated baseline expression levels of the biomarker A3AR were enrolled in the study. CF101 met all primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of rheumatoid arthritis.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company’s CF101 is in Phase II/III trials for the treatment of psoriasis and the Company is preparing for a Phase III CF101 trial for rheumatoid arthritis. Can-Fite’s liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company’s CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com

CAESAREA, Israel, March 18, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, today reported that it has concluded a 368 patient user performance study on the Dario. The results showed that usability of the Dario Diabetes Management Solution is simple and intuitive. The accuracy of Dario has proven to surpass other glucose meters and delivers accuracy that exceeds the minimum new stringent guidance of the ISO 15197:2013.

The successful clinical study is an important milestone, it allows the completion of the 510(k) application for Dario and is a significant step towards the Dario anticipated approval and commercialization in the USA.

The comparative, observational, single-arm User Performance Evaluation study was performed in Columbus Ohio, USA and consisted of 368 subjects having Type I or Type II diabetes. The study was conducted using the Dario all-in-one blood glucose monitoring solution indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The objectives of the study were to evaluate the performance of blood glucose levels taken from the Dario meter compared to the industry’s standard references for usability and performance. The study criteria was derived using a combination of the European ISO-15197:2013 In Vitro Diagnostic Test Systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus standard as well as the FDA’s more stringent draft guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use document issued on January 7, 2014.

LabStyle also announced the addition of Mr. Bill McGrail to its management team as VP Regulatory. Mr. McGrail brings to Dario over 25 years of experience in the medical device industry particularly new product development of blood glucose meters and regulatory and quality affairs for clearance and distribution of medical products in the U.S., European Union, Canada and a number of other foreign markets. Mr. McGrail is a valuable strategic addition to the Dario team and will lead and support Dario through the regulatory approval process as well as the anticipated introduction to the US market.

In previous roles, Mr. McGrail served as VP of Research and Development for AgaMatrix Inc., where he was responsible for the design and development of state of the art blood glucose meters. As VP of Regulatory, Quality and Clinical, he was responsible for the worldwide clearance of the blood glucose meters and fully integrated mobile health manager apps.

Erez Raphael, president and chief executive officer of LabStyle Innovations, stated “We are very pleased with the results of this important study. The successful study shows that the Dario™ Blood Glucose Monitoring System is highly comparable to its predicate device and can be a valuable tool to the US diabetic community. Mr. Raphael continued; “We welcome Bill McGrail to our management team. We are confident that his vast experience and knowledge in the area of blood glucose meters, their regulation and global distribution will accelerate our regulatory approval and distribution roadmap.”

DURHAM, N.C., March 9, 2015 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (“Heat”) (HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HS-410 (vesigenurtacel-L) for the treatment of non-muscle invasive bladder cancer (NMIBC). HS-410 is Heat’s NMIBC product candidate and is based on its cutting-edge Immune Pan Antigen Cytotoxic Therapy (“ImPACT”) platform that is designed to generate killer T cells to attack cancers. HS-410 is currently being evaluated in a randomized Phase 2 trial in combination with BCG and as monotherapy for the treatment of NMIBC.

“We are very pleased that FDA has granted this important designation for HS-410,” said Melissa Price, Ph.D., Heat’s Vice President of Clinical Development and Regulatory Affairs. “The decision underscores the unmet need for bladder cancer treatments and serves as an additional validation for our clinical program. Currently there are limited therapeutic treatment options available for this patient population, with no new treatments approved in this setting in over 30 years.”

About FDA Fast Track Designation

The FDA established the Fast Track Drug Development Program under the FDA Modernization Act of 1997. The program is designed to facilitate the development and expedite the review of therapies intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The advantages of Fast Track designation include actions to expedite development, including opportunities for frequent interactions with the FDA review team to discuss all aspects of development to support approval and eligibility for priority review depending on clinical data at the time of Biologics License Application (BLA) submission.

About Bladder Cancer and HS-410

According to the American Cancer Society, bladder cancer is the fifth most common cancer in the US with approximately 75,000 new cases in 2014 and 16,000 deaths. About 75% of the newly diagnosed patients have NMIBC. A key issue for bladder cancer is the high rate of recurrence, for which limited treatment options are available beyond complete bladder removal. Heat Biologics is examining candidate HS-410 in conjunction with standard treatment to stimulate the immune system and eliminate remaining cancer cells to prevent recurrence. The Company completed enrollment in a Phase 1 study and is expected to release interim data on 10 patients in the first half of 2015. A Phase 2 clinical trial is ongoing with a primary endpoint of recurrence-free survival. Heat is expected to complete enrollment in the Phase 2 study in the third quarter of 2015, which would make topline data available in the second half of 2016.

Sanjay Sabnani, Chairman and CEO of Crowdgather (CRWG), talks about the company’s merger with Plaor, the social gaming sector, and the future of CrowdGather.

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