PETACH TIKVA, Israel, Nov. 23, 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 diseases, cancer, and sexual dysfunction, today announced development of its drug candidate CF102, which is currently in Phase II trials for hepatocellular carcinoma (HCC) the most common form of liver cancer, will be expanded into treatment for non-alcoholic steatohepatitis (NASH).

NASH is characterized by excess fat in the liver along with inflammation and liver damage. It resembles alcoholic liver disease; however, it occurs in people who drink little or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. According to the National Institutes of Health, NASH affects between 2% and 5% of Americans and the prevalence of NASH has been increasing, potentially due to increasing rates of obesity and diabetes. By 2025, Deutsche Bank estimates the addressable pharmaceutical market for NASH will reach $35-40 billion in size. As of today, while there are several companies developing drugs to treat NASH that are in preclinical and clinical development, no specific U.S. Food and Drug Administration (FDA) approved treatment for NASH exists.

“Results from our recently concluded preclinical study of CF102 in liver disease revealed compelling data. Based on these findings, we’ve filed a patent for CF102 in the treatment of NASH,” stated Can-Fite CEO Dr. Pnina Fishman. “Because the prevalence of NASH continues to grow and no treatment currently exists, our data support the development of CF102 for the treatment of NASH.”

CF102 revealed its capability to improve liver pathology in a NAFLD (non-alcoholic fatty liver disease)/diabetes animal model of NASH. The data showed:

CF102 had a statistically significant reduction in NAFLD activity score compared to placebo.
CF102 reduced liver-to-body weight compared to placebo.
Representative photomicrographs of H&E-stained liver sections showed improved pathology in animals receiving CF102 vs. placebo.
CF102 decreased plasma ALT and triglycerides levels in the livers of NASH-model compared to placebo.
Liver sections from the placebo group exhibited severe micro- and macrovesicular fat deposits, hepatocellular ballooning and inflammatory cell infiltration, whereas the CF102 treated group showed a significant decrease in steatosis, ballooning and lobular inflammation compared to the placebo group.
In prior preclinical studies, CF102 has shown efficacy in the treatment of liver regeneration and function following liver surgery.

Can-Fite currently has a U.S. Investigational New Drug (IND) application active with the U.S. FDA for CF102. CF102 is currently being evaluated as a second-line treatment for HCC through a global Phase II trial. Can-Fite has received Orphan Drugs Designation for CF102 for this indication in Europe and the U.S., as well as Fast Track Status in the U.S. Data from the Phase II HCC study is expected in 2016.

JERUSALEM, Nov. 30, 2015 /PRNewswire/ — Oramed Pharmaceuticals Inc. (ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has signed definitive licensing and investment agreements valued at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., Ltd. (“HTIT”) for exclusive rights to market Oramed’s oral insulin capsule, ORMD-0801, in China, Hong Kong and Macau. The agreements were signed at the Israel Knesset (Parliament).

The license agreement payments include a $3 million payment due upon execution of the agreement, $8 million in near-term payments subject to Oramed entering into certain agreements and the balance payable upon achievement of certain milestones. In addition, if all conditions are met, HTIT will pay a 10% royalty on net sales of the related commercialized products.

In addition to the contemplated payments under the license agreement, pursuant to the investment agreement, Oramed will issue to HTIT 1,155,469 restricted shares of Oramed’s common stock at a price per share of approximately $10.39 and $12 million in total, subject to customary closing conditions.

“China recently became the country with the largest number of diabetics in the world. Having signed these definitive license and investment agreements, our oral insulin capsule could help serve the growing population of people in China living with diabetes,” stated Oramed’s CEO Nadav Kidron. “In addition to the $50 million in milestone payments and investments, we believe the royalties on net sales throughout China will have a very significant impact on Oramed’s future revenues and earnings, upon market approval of ORMD-0801 in China.”

About Hefei

HTIT, which is partially owned by Sinopharm Group Company Limited, has state of the art insulin production facilities in Hefei, China. HTIT has a business focus which includes industrial investment and incubation services; high-tech product R&D; technology transfer and related consulting services.

HAIFA, Israel, Dec. 03, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today announced that it has signed a Memorandum of Understanding (MOU) for a collaboration with Fukushima Medical University, Fukushima Global Medical Science Center. The purpose of the collaboration is to develop Pluristem’s PLX-R18 cells for the treatment of Acute Radiation Syndrome (ARS), and for morbidities following radiotherapy in cancer patients.

ARS is caused by exposure to dangerously high levels of radiation, such as could occur in a nuclear catastrophe, and incorporates potentially lethal damage to the gastrointestinal tract, lung, skin and bone marrow, as well as other systems. In this new collaboration PLX-R18 cells will be studied primarily as a potential treatment for radiation-induced damage to the skin, lungs and gastrointestinal tract. The parties intend to develop preclinical models of radiation damage in these tissues, and then use them in trials. Pluristem will contribute PLX-R18 cells and scientific knowledge, while Fukushima Medical University will conduct the studies, and provide the required resources.

The collaboration will proceed alongside research supported by the U.S. National Institutes of Health (NIH), which is studying PLX-R18 as a potential treatment for the hematologic component of ARS. Insufficient blood cell production by the bone marrow, which may be caused by various reasons including ARS and cancer treatments, can be life threatening because it may lead to hemorrhage, the inability to fight infection, and anemia.

Data from a preclinical study, published in the peer-reviewed scientific journal PLOS One, suggest that PLX-R18 cells, administered intramuscularly, may be a highly effective off-the-shelf therapy for bone marrow failure following total body exposure to high doses of radiation. The work with Fukushima Medical University, Fukushima Global Medical Science Center will further evaluate the efficacy of intramuscular administration for systemic treatment of ARS.

“The researchers at Fukushima have a strong interest in cell therapies that may offer a treatment for conditions caused by exposure to ionizing radiation. We are honored to work with the thought leaders in the field at Fukushima Medical University, Fukushima Global Medical Science Center to further develop PLX-R18 for ARS-related indications,” stated Pluristem CEO Zami Aberman.

“We anticipate that our work with Fukushima Medical University, Fukushima Global Medical Science Center will help to maintain the health of those involved in decommissioning the Fukushima reactors; the decommissioning process is estimated to take about 40 years. We hope that this collaboration can advance efforts to safeguard populations around the world from illness related to radiation exposure,” concluded Mr. Aberman.