HAIFA, Israel, April 20, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, today announced that its Clinical Advisory Board for Critical Limb Ischemia (CLI) concluded a key meeting in London, England. During the meeting, Clinical Advisory Board members, including Key Opinion Leaders in the treatment of CLI, outlined the Phase II study design and other critical components of advanced-stage trials for the Company’s PLacental eXpanded (PLX) cells in the treatment of this peripheral artery disease.

Pluristem has applied to conduct Phase II trials for CLI in regions with recently established rapid regulatory pathways, including the Accelerated Pathway for Regenerative Therapy in Japan and the Adaptive Pathway in the European Union.

“We believe PLX-PAD could potentially be three years from commercialization, contingent upon successful trials and approval via accelerated regulatory pathways in Japan and Europe. Our Clinical Advisory Board has provided invaluable expertise in generating our Phase II trial protocols, and we are eager to move forward with them,” stated Zami Aberman, Pluristem’s Chairman and CEO.

Two Phase I studies for CLI, previously completed in the U.S. and Germany, met all primary endpoints. Data from these trials suggested that the cells were safe and potentially efficacious at multiple dosage levels in this indication.

ROCKVILLE, Md., April 21, 2015 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that it presented preclinical data on Supinoxin(TM) (RX-5902) at the 2015 American Association for Cancer Research (AACR) Annual Meeting in Philadelphia. This presentation entitled, “Targeting localization and function of the RNA helicase DDX5/p68 with 1-(3,5-dimethoxyphenyl)-4-[(6-fluoro-2-methoxyquinoxalin-3-yl) aminocarbonyl] piperazine (RX-5902)” was co-authored by Frances Fuller-Pace Ph.D., Division of Cancer Research, University of Dundee, United Kingdom and Rexahn scientists.

In the present study, Supinoxin(TM) (RX-5902) was shown to dose-dependently decrease the migration of human triple negative breast cancer cells (MDA-MB-231) in a preclinical model of cancer cell metastasis.

Dr. Fuller-Pace commented, “RX-5902 was effective in blocking the migration of human triple negative breast cancer cells (MDA-MB231). This is very encouraging, suggesting its potential utility for the treatment of malignant tumors.”

“We continue to be encouraged by the preclinical and clinical data seen with Supinoxin(TM). Phosphorylated p68 appears to be involved in cancer cell survival and growth as well as tumor metastasis, suggesting that Supinoxin(TM) may play a role in treating difficult cancers such as triple negative breast cancer where metastatic disease is a common occurrence and is one of the main factors that impact prognosis,” commented Ely Benaim, M.D., Rexahn’s Chief Medical Officer.

Supinoxin is currently in a Phase I dose-escalation clinical trial in cancer patients with solid tumors with clinical data expected in the first half of 2015.

PETACH TIKVA, Israel, April 20, 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 submitted an application to the European Medicines Agency for Orphan Drug Designation for its drug candidate CF102 in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.

CF102 is currently in a Phase II trial in the U.S., Israel, and Europe. The study enrolls HCC patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar (sorafenib). The patients are treated twice daily with 25 mg of CF102, which has been found to be the most efficacious dose in our earlier Phase I/II study resulting in the longest overall survival time. CF102 is a stable drug which is hardly metabolized in the liver and therefore is suitable for treatment of liver diseases. In addition, the 25 mg dose had an excellent safety profile in the Phase I/II study and showed no hepatotoxicity and even maintained liver function in patients with advanced liver disease.

Can-Fite has already been granted Orphan Drug Status for CF102 for the indication of HCC by the U.S. Food and Drug Administration. CF102 is also approved for Compassionate Use by Israel’s Ministry of Health.

If CF102 is granted Orphan Drug Designation in Europe, Can-Fite would benefit from incentives including protocol assistance, fee reductions, and market exclusivity once the medicine is on the market for up to 10 years in European Union member nations.

“As we are currently conducting our Phase II trial for CF102 in the treatment of liver cancer, we believe this is an opportune time for us to apply for Orphan Drug Designation in Europe. If our Phase II study results are favorable, then this designation would grant us the European Medicines Agency’s valuable assistance in the development of our Phase III study protocol,” stated Pnina Fishman, CEO of Can-Fite. “Upon marketing approval, receiving market exclusivity for CF102 would be significantly beneficial to Can-Fite.”

According to Global Industry Analysts, the global market for liver cancer is projected to exceed $2 billion by 2015.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that Aintree University Hospital, in Liverpool, England, has become a clinical site for the Company’s global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). This is the first center to join the Multikine Phase III study in the UK.

Aintree University Hospital is a large teaching hospital in Liverpool providing a range of acute and non-acute specialties. The hospital offers specialist services with a world-class reputation to a population of 1.5 million residents across the Northwest of England. The Principal Investigator for the trial site is Professor Richard Shaw. He serves as Honorary Consultant in Oral & Maxillofacial / Head and Neck Surgery at Aintree University Hospital and is a surgeon specializing in head and neck cancers at the University of Liverpool.

“Dr. Shaw is a Key Opinion Leader in head and neck cancer who has participated in numerous trials exploring better ways to treat cancer. We are honored to have his participation and expertise in our trial.” stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine Phase III Study

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only. A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in about 25 countries.