JERUSALEM, June 21, 2016 /PRNewswire/ — Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a developer of oral drug delivery systems, today announced that Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT) is transferring a $6.5 million milestone payment from the previously-announced license and investment agreement between Oramed and HTIT. The payment follows Oramed’s positive top-line results from its Phase IIb U.S. Food and Drug Administration trial designed to evaluate the safety and efficacy of Oramed’s oral insulin capsule ORMD-0801 in patients with type 2 diabetes.

Per the terms of the agreement signed in December 2015, Oramed granted HTIT exclusive rights for commercialization of ORMD-0801 in Greater China. The up to $50 million license deal includes multiple milestone payments aggregating $38 million, with a $3 million upfront payment received by Oramed upon execution of the agreement, plus a $12 million investment made by HTIT in Oramed at $10.39 per share in December 2015. Oramed will receive a 10% royalty on net sales of ORMD-0801 and related commercialized products in Greater China.

“The completion of this milestone signifies our deepening partnership with HTIT as we move closer to bringing oral insulin to the vast and growing Chinese diabetes market,” said Nadav Kidron, CEO of Oramed.

“The positive Phase IIb data has further illustrated the huge potential this technology can have in China,” said HTIT CFO & Oramed Board Member Xiaopeng Li. “We are working diligently to lay the groundwork for the successful production and commercialization of ORMD-0801 focused on the Greater China market.”

About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD™) technology is based on over 30 years of research by scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).

JACKSONVILLE, Florida, June 21, 2016 /PRNewswire/ —

TapImmune,Inc. (TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, today announced reaching a major milestone of dosing its first patient in a Phase 2 trial for triple negative breast cancer with its cancer vaccine TPIV 200. The first patient enrolled is being treated at the University of Maryland – one of 8 sites being used in this study, conducted and funded by TapImmune.

The randomized, open label Phase 2 study is expected to enroll a total of 80 subjects. The primary endpoints are dosing regimens and safety. Secondary endpoints are T-cell specific responses and evaluation of objective responses.

Dr. Glynn Wilson, Chairman and CEO of Tapimmune stated, “Enrolling and treating this first patient represents the start of a robust and intensive Phase 2 clinical program for our lead product TPIV 200, a Folate Receptor Alpha T-cell vaccine.”

TPIV 200 is currently being investigated in two other Phase 2 trials at the Mayo Clinic and at Memorial Sloan Kettering.

“Enrollment has started in the Phase 2 40 patient study at Memorial Sloan Kettering in collaboration with Astra Zeneca in late-stage ovarian cancer. In addition, the large 280 patient Phase 2 trial being run at the Mayo Clinic with a grant from the Department of Defense is expected to start enrollment later this year,” Dr. Wilson added.

TapImmune has received Fast Track Status and Orphan Drug Designation for TPIV 200. The Company plans to initiate a fourth Phase 2 clinical study, in late 2016, designed to treat platinum-sensitive ovarian cancer patients.

“The clinical strategy for TPIV 200 is designed to examine the potential for this exciting T-cell vaccine in as many clinical settings as possible using the most cost-effective pathways. We are excited by the potential for this drug candidate and believe positive data from the Phase 1 study will be reflected in the results of our ongoing Phase 2 clinical investigations,” Dr. Wilson concluded.

Interested investors in TapImmune’s clinical studies can learn more by going to: http://www.clinicaltrials.gov

TEL-AVIV, June 24, 2016 /PRNewswire/ — Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced newly available data from its successfully completed Phase III study of KIT-302 suggest beneficial effects on kidney(renal) function. Damage to renal function is a serious side effect of NSAIDs.

The Company’s combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two U.S. Food and Drug Administration approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.

Further analysis of data obtained in the Phase III clinical trial, whose top line results were announced in December 2015,showed that celecoxib increased serum creatinine compared to placebo;impaired renal function is a major concern with nonsteroidal anti-inflammatory drugs (NSAIDs). In contrast, while amlodipine alone reduced serum creatinine (-2.55 umol/L), a greater reduction in plasma levels of creatinine was achieved in patients in the KIT-302 arm (-3.22 umol/L), suggesting better renal function.

Additional data supporting the conclusion that KIT-302 is beneficial to renal function were measurements of peripheral edema, a known side effect of calcium channel blockers, such as amlodipine. Peripheral edema was reported in 15.6% of patients receiving amlodipine but in only 8.2% of patients receiving KIT-302. These data suggest that KIT-302 protects against the widely recognized undesirable side effect of amlodipine in causing fluid retention by the kidneys.

Dr. Paul Waymack, Kitov’s Chief Medical Officer,said: “We are very pleased with the outcome of the renal function analysis. We believe it demonstrates that in addition to addressing hypertension side effects caused by celecoxib, KIT-302 also addresses fluid retention resulting from amlodipine: a known side effect caused by calcium channel blockers.”

“Given the potential marketing advantages of these findings,we intend to conduct a clinical trial designed to scientifically validate these beneficial renal effects in parallel with the New Drug Application we plan to submit at the end of 2016,” stated Chief Executive Officer Isaac Israel. The study may also provide an explanation for the synergistic antihypertensive effect, where the reduction in blood pressure demonstrated with KIT-302 was higher than that observed with amlodipine alone.”

HAIFA, Israel, June 22, 2016 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI), (PSTI)/(PLTR), a leading developer of placenta-based cell therapy products, today reported positive data from preclinical studies of its PLX-PAD cells in the treatment of Duchenne muscular dystrophy. The studies were conducted in conjunction with ADI, the Association Duchenne Israel, whose members are parents of children with Duchenne. They are committed to helping to find a cure for Duchenne muscular dystrophy through research, clinical trials, and advocacy.

Duchenne muscular dystrophy is the most common neuromuscular disorder, and affects roughly one in 3,500 boys. The disease causes progressive muscle weakness, and leads to severe disability and death. There is currently no cure.

Following Pluristem’s announcement of positive results from a Phase II clinical trial of PLX-PAD as a treatment for muscle injury, the Association Duchenne Israel approached Pluristem with a request to study PLX-PAD cells in Duchenne muscular dystrophy. Pluristem donated PLX-PAD cells for the preclinical studies, and the association supported the research in cooperation with Science in Action Ltd.

The studies demonstrated that, in a mouse model of muscular dystrophy, PLX-PAD cells reduced creatine phosphokinase (CPK), a marker of muscle degeneration or injury, by approximately 50% as compared to placebo. CPK levels were measured via a blood sample taken 5 days after each intramuscular PLX-PAD injection made at day 15 and day 29 of the study. Histological analyses of quadriceps and diaphragm muscles show PLX-PAD reduced levels of inflammation and necrosis, a type of cell death, and induced regeneration of muscle tissue.

Hila Krupsky, CEO of ADI, the Association Duchenne Israel, stated, “These preclinical data suggest that PLX-PAD cells could possibly be a breakthrough therapy to help treat symptoms of Duchenne muscular dystrophy. We are thankful for Pluristem’s donation of PLX-PAD and are eager to continue studying the cells since new therapeutic approaches are needed to manage this disease, save children’s lives, and give them hope and a chance for the future.”

“Because PLX-PAD cells have already displayed efficacy in muscle regeneration in a Phase II muscle injury study, we believe our cell therapy may potentially be beneficial in Duchenne muscular dystrophy in human clinical trials,” said Pluristem Chairman and CEO Zami Aberman. “We admire the commitment of the Association Duchenne Israel to find a cure for Duchenne muscular dystrophy, and we will work closely with them in an effort to develop a treatment for the children around the world who suffer from this disease.”