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.

JERUSALEM, April 28, 2015 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com)

Dear Friends, Shareholders and Associates,

I am very excited to announce that we are on the threshold of initiating our much-awaited Phase IIb clinical trial for oral insulin (ORMD-0801) and the treatment of type 2 diabetes. Our goal is to commence the trial in the coming weeks. This clinical trial will be our largest and most comprehensive study to date and marks a significant milestone for the company, literally putting us in a different place.

The Phase IIb study will build directly on the success of our two Phase IIa studies which were completed in 2014. This study will be significantly larger in scope and design than the prior studies so as to demonstrate both efficacy and safety as primary endpoints.

I am happy to share, that the study has already received Institutional Review Board (IRB) approval and we plan on submitting the study’s protocol to the Federal Drug Administration (FDA) in the coming month of May, which will be followed soon thereafter by study enrolment. We are positioned for an efficient recruitment process, having successfully recruited over 30 clinical sites, which include some of the most prestigious clinics and investigators in the United States.
We look forward to embarking on this important next step and, as usual, we will keep you abreast as this study progresses.

Sincerely,

Nadav Kidron, CEO

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that in April it enrolled 31 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). April marks the 4th consecutive month of record enrollment for CEL-SCI this year following January, February and March, 2015. Enrollment was 24 patients in January, 25 patients in February and 29 patients in March. Four hundred thirty-seven (437) patients have been enrolled in the Phase III study as of April 30, 2015.

“We are very pleased with the enrollment, particularly since there were major holidays this month that made enrollment much more difficult,” 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.

CAESAREA, Israel April, 2015 /PRNewswire/ —
LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, today reported it has opened its first ecommerce store for the Dario Smart meter and Dario accessories. The eShop serves the Israeli market, where the Dario Management Solution was launched in July 2014 following approval from the Israeli Ministry of Health. The Dario has received wide commendations and endorsements from both the medical community and the population of patients in Israel.
The eShop offers a platform for people with diabetes to directly purchase the Dario and get the support, knowledge and tools to manage their diabetes personally using their mobile devices. As LabStyle’s first eShop, this will serve an ecommerce model for LabStyle Innovations, as it plans to open ecommerce sites to serve other geographic markets where diabetes is prevalent and there is an need for a complete diabetes management solution.
“As more and more emphasis is being placed on the need for improving patient compliance and self-management it is important that people are able to find a comprehensive management solution so easily online to help them thrive while living with diabetes,” said Erez Raphael, LabStyle’s President and Chief Executive Officer. “The Dario smart meter delivers just what patients are looking for in an intuitive and easy to use tech-driven solution. We have witnessed proven improvements in user performance and increased patient compliance when people use the Dario. It is extremely encouraging to receive such as great vote of confidence from the community of patients and medical professionals. We look forward to capturing what we believe is an immense opportunity for Dario in developing this online direct sales approach in the other targeted markets.”

About LabStyle Innovations

LabStyle Innovations Corp. (OTCQB:DRIO) develops and commercializes patented technology providing consumers with laboratory-testing capabilities using smart mobile devices. LabStyle’s flagship product is the Dario™ Diabetes Management Solution. Dario™ empowers people with diabetes to take charge of their health with the right tools, insights, and support in their pocket. With access to both real-time and historical blood glucose data, Dario™ is designed to spot patterns, recommend the right treatments and support behavior change efforts. Dario™ is a platform that combines an all-in-one, blood glucose meter, smart phone application (iOS & Android), website application and treatment tools to support more proactive and better informed decisions by patients, doctors and healthcare systems. The stylish and compact self-monitoring system combines a lancet to obtain a blood sample, a proprietary disposable test strip cartridge and a smartphone-driven glucose meter. LabStyle Innovations is led by an experienced management team with vast software, medical device and technology experience and guided by a world class board of directors and scientific advisory board. For more information: www.myDario.com

PETACH TIKVA, Israel, April 27, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today favorable data from further analysis of its Phase II/III double-blind, placebo-controlled study designed to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis.

The study included 326 patients through 17 clinical centers in the U.S., Europe, and Israel with a duration of 32 weeks where the primary endpoint was after 12 weeks. On March 30, 2015, Can-Fite announced the study did not meet its primary endpoint of a statistically significant improvement in the Psoriasis Area Severity Index (PASI) 75 score relative to placebo after 12 weeks of treatment. However, based on further analysis of the efficacy and safety results from the study as described below, Can-Fite intends to continue the development of CF101 for the treatment of psoriasis and has initiated work on the design of the next advanced–stage clinical trial protocol.

Further analysis of the entire study period revealed that by 32 weeks of treatment with CF101, 33% of the patients achieved PASI 75 while the mean percent of improvement in PASI score was 57% . This was a statistically significant cumulative and linear improvement during weeks 16 to 32.

Most significantly, by week 32 of the study, 20% of the study patients reached PASI 90, a result demonstrating a response rate of 90% clearing of skin lesions. PASI 90 is one of the most stringent and difficult to meet clinical endpoints for measuring responses to psoriasis treatments. Moreover, the PASI 90 subset analysis further suggests a higher and significant (p=0.026) CF101 response rate of 27% among patients previously untreated with systemic psoriasis therapy compared to patients pre-treated with systemic drugs. The Company believes this presents the opportunity that CF101 can be developed as a first-line systemic therapy for patients with moderate-severe psoriasis and for patients who do not want to be treated with the current systemic drugs due to safety issues. Currently there is no universally accepted first-line systemic therapy for patients diagnosed with psoriasis, and therefore CF101, an orally bioavailable drug with an excellent safety profile can be positioned for this unmet need.

“The cumulative and linear improvement in CF101’s efficacy treating moderate to severe psoriasis over a longer period of time is a very significant finding for Can-Fite and the psoriasis treatment market. Based on the very favorable safety data on CF101 from this and other trials, coupled with its oral administration, we believe CF101 offers a valuable potential treatment solution for psoriasis and we are committed to continuing our development program,” stated Can-Fite CEO Dr. Pnina Fishman. “We are particularly encouraged by the new data that show CF101 could serve as a first-line therapy for moderate-severe psoriasis based on the higher efficacy in patients who were previously not treated with systemic therapy.”

LabStyle Innovations develops and commercializes patent-pending technologies that provide consumers with laboratory-testing capabilities using smart mobile devices.

LabStyle’s flagship product is Dario™ the world’s first personalized smart meter. Dario combines a compact all in one glucose meter that plugs directly into a smart mobile device with personalized information and community support to make life easier for people with diabetes.

To learn more about LabStyle Innovations and Dario (DRIO) visit: www.mydario.com

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.