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.”