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PETACH TIKVA, Israel, July 29, 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, today announced that the World Health Organization’s International Nonproprietary Name group has accepted the proposed generic name “piclidenoson” for its lead drug candidate, CF101.

“We are pleased that the World Health Organization recognized the very unique pharmacological nature of CF101 and has granted it a new generic name,” stated Can-Fite CEO Dr. Pnina Fishman. “This is a very important step towards bringing a new drug to market and comes at an important time for Can-Fite as we prepare to enter advanced stage clinical trials for CF101 in rheumatoid arthritis and psoriasis.”

International Nonproprietary Names (INN) facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. The INN system’s aim is to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.

JERUSALEM, July 7, 2015 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has signed a non-binding Letter of Intent (LoI) for an investment and license agreement in China with Sinopharm Capital Management Co. Ltd. and Hefei Life Science & Technology Park Investments and Development Co., Ltd. (Sinopharm/Hefei) potentially valued at $50,000,000 plus royalty payments. Oramed will receive $500,000 in exchange for exclusively negotiating with Sinopharm/Hefei for 60 days, while the final terms of the agreement are negotiated and finalized.

The transaction which additionally includes 10% royalties on sales, will allow Sinopharm/Hefei to purchase a roughly 10% stake in Oramed Pharmaceuticals and acquire rights for oral insulin in China. The terms are to be broken down as follows: Oramed will sell Sinopharm/Hefei 1,155,367 shares of common stock for approximately $12,000,000. In addition, Oramed’s wholly owned subsidiary, Oramed Ltd, will license to Sinopharm/Hefei the exclusive rights to ORMD-0801, oral insulin capsule in China, for a total amount of $38,000,000, of which $18,000,000 will be paid upon the signing of the license agreement and the remaining $20,000,000 will be paid following the completion, and release of results, of Oramed’s current Phase IIb trial in the United States.

CAESAREA, Israel, July 14, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), today announced the Dario™ Diabetes Management Solution’s Smart Meter test strips are now reimbursed in Canada by most private insurance plans after the Dario™ was launched in Canada through major pharmacies including London Drugs and online at www.mydario.ca.

“Within a week of launching Dario in Canada over 75% of Canadian medical plans are now covering Dario™ test strips with reimbursement and we expect the balance to come on board over the coming weeks. Reimbursement of the recurring expense of test strips will make it even easier for Canadians to adopt Dario™, which we believe significantly enhances quality of life for people living and thriving with diabetes,” stated Erez Raphael, President and CEO of LabStyle Innovations.

The compact all-in-one system that helps people with diabetes monitor blood sugar levels and proactively manages their diabetes using their smartphone or tablet is distributed in Canada by Auto Control Medical. Dario™ connects via a headphone jack to turn a mobile device into a glucose monitor, and incorporates a lancing device and test strips together with the meter in an all-in-one easy to carry device to take blood glucose measurements on the spot. Unlike conventional glucose monitors, there is no carrying case or batteries to replace, and the system works on both Apple and Android devices. Dario™ provides the diabetes patient’s real-time and historical blood glucose data to spot patterns, recommend treatments and support behavior changes. Its web interface also makes it easy to share health information with healthcare providers and loved ones.

ROCKVILLE, Md., July 14, 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 was issued patent number 5749273 from the Japanese Patent Office entitled “Polymeric Systems for the Delivery of Anticancer Drugs” for the Company’s novel CPMA drug delivery platform. This new CPMA drug delivery platform technology, developed by Rexahn, enables more precise, targeted delivery of anti-cancer drugs directly into cancer cells.

“There is a significant unmet need in the oncology field for drugs which selectively target and kill cancer cells while sparing normal, healthy cells. By utilizing our proprietary CPMA polymer drug delivery technology and combining it with currently approved anti-cancer drugs, we hope to transport anti-cancer drugs directly into cancerous cells where their cytotoxic activity can be most effective, thereby increasing efficacy and minimizing the harmful side effects associated with traditional cancer therapy,” said Dr. Peter D. Suzdak, Chief Executive Officer. “Rexahn Pharmaceuticals is pleased to be at the forefront of the development of novel, targeted approaches to cancer treatment, which could yield meaningful improvements in quality of life for cancer patients.”

Dr. Suzdak continued, “Rexahn remains committed to ensuring the strongest possible intellectual property protection for our proprietary anti-cancer programs and platform technologies. We are pleased to be issued this latest patent, which expands our intellectual property estate and extends intellectual property protection for the CPMA platform.”

About Rexahn’s Proprietary CPMA Drug Delivery Platform

CPMA is a polymer based drug delivery platform for the targeted delivery of anti-cancer compounds directly to cancer cells. The highly versatile chemical properties of CPMA allow it to be covalently linked to a diverse range of anti-cancer compounds together with a signaling moiety directing it to cancer cells and bypassing healthy tissues. Once inside a cancer cell, the covalent linker is metabolized yielding the free anti-cancer compound. CPMA has the flexibility to covalently bind multiple anti-cancer compounds into a single formulation. Because it is highly water soluble, CPMA also enables compounds that are water insoluble to be more effectively delivered and bioavailable.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the “Company”) today announced it has added a second clinical site for its Phase I clinical trial evaluating peri-anal wart immunotherapy in HIV/HPV co-infected men and women with its investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection). Dr. Joel Palefsky, world renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, has joined the study as a Principal Investigator at the University of California San Francisco (UCSF). UCSF becomes the second clinical site for the study. The first site, the U.S. Naval Medical Center San Diego, continues to enroll patients under a Cooperative Research and Development Agreement (CRADA).

Dr. Joel Palefsky is the Chair of the HPV Working Group of the AIDS Malignancy Consortium (AMC) and is the head of the AMC HPV Virology Core Lab at UCSF. The AMC is a U.S. National Cancer Institute-supported clinical trials group founded in 1995 to support innovative trials for AIDS-related cancers. The AMC is composed of over 37 clinical trials sites worldwide, five Working Groups, an Administrative Office, a Statistical Office, and an Operations and Data Management Office. Collectively, these components develop and oversee the scientific agenda, manage the groups’ portfolio of clinical trials and other scientific-based studies, and help to develop new protocols. Dr. Palefsky has extensive experience in the biology of HPV infection, HPV infection in HIV-positive men and women, HPV vaccines and in the design and implementation of multiple clinical research trials of HPV-related disease.

Having published over 280 papers, Dr. Palefsky is Principal Investigator of the ANCHOR study, an $89 million NIH-funded study of the efficacy of secondary prevention of anal cancer. He is also the Principal Investigator on several laboratory-based and clinical research studies of HPV-associated neoplasia, particularly in the setting of HIV infection. He also specializes in the molecular biology and development of new treatments for HPV. Dr. Palefsky is the founder and immediate past president of the International Anal Neoplasia Society and is currently president of the International Human Papillomavirus Society. He is actively involved in training students in clinical and translational research. Dr. Palefsky has led the Doris Duke Charitable Foundation (DDCF) program at UCSF since its inception in 2001 and has been the leader of the Clinical Translational Science Awards (CTSA) TL1 program at UCSF since its inception in 2006.

“We are very pleased to welcome Dr. Palefsky as a Principal Investigator for our Phase I study and we believe his interest in Multikine is a very important testament of our immunotherapy’s potential in the treatment of HPV related diseases in HIV infected patients,” stated CEL-SCI Chief Executive Officer Geert Kersten. “Dr. Palefsky is widely recognized as one of the world’s top researchers in the field HPV infection in HIV co-infected patients. With his participation through UCSF we anticipate rapid patient enrollment in our Phase I study.”

Anal and genital warts are commonly associated with HPV, the most common sexually transmitted disease. The U.S. Center for Disease Control and Prevention (CDC) has named HPV the 4th largest health threat the U.S. will face in 2014. According to the CDC, 360,000 people in the U.S. get genital warts each year. Persistent HPV infection in the anal region is thought to be responsible for up to 80% of anal cancers. HPV is an even more significant health problem in the HIV infected population as individuals are living longer as a result of greatly improved HIV medications, but have difficulty clearing HPV due to their compromised immune system.

Combination Pan-Antigen Cytotoxic Therapy (ComPACT) Designed to Deliver T-Cell Priming and Co-Stimulatory Molecules in a Single Product

Conference Call and Webcast Today at 8:30am EDT

DURHAM, N.C., June 15, 2015 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (“Heat”), (HTBX), a clinical stage cancer immunotherapy company, today announced the development of its next-generation combination immunotherapy platform, which combines a pan-antigen T cell priming vaccine and T cell co-stimulator in a single product. This platform, named ComPACT, has been engineered to incorporate various fusion proteins targeting co-stimulatory receptors (OX40, ICOS, 4-1BB), enabling the combination of two important immunotherapy pathways in a single therapy. Data generated using the ComPACT platform are being presented today at the Cell Symposia, ‘Cancer, Inflammation and Immunity’ in Sitges, Spain. The Company will also be hosting a webcast today to present these data.

Taylor Schreiber, MD, PhD, Heat’s Vice President of Research, who led development of ComPACT, commented: “It is now widely recognized in the clinical community that combinations between checkpoint inhibitors, T cell co-stimulators, and vaccines can provide superior benefits to any single modality as monotherapy. The first challenge in developing these combinations is to systematically identify synergistic pathways from redundant or antagonistic ones. Another challenge is to deploy combination immunotherapies that may limit systemic toxicity and offer an advantageous overall cost structure compared to combining multiple biologic therapies. Heat’s ComPACT therapy is designed to achieve these goals.”

The presentation by George Fromm, PhD, Heat’s Director of Research, reveals the first preclinical analysis of ComPACT, incorporating OX40L-Fc, demonstrates significant benefits as compared to traditional OX40 agonistic antibodies. Dr. Fromm commented: “The magnitude of T cell stimulation with ComPACT was somewhat unexpected, but clearly demonstrates substantial increases for both primary and memory immune response to those seen by co-administration of a vaccine and OX40 agonist antibody.” The data illustrate that systemic OX40 stimulation through antibody therapy led to increased off-target T cell activation, and that the beneficial response with ComPACT may be due to increased specificity.

Although the data presented include combinations between gp96-Ig vaccination and stimulation of OX40, the platform has also been developed to target other T cell co-stimulatory receptors including ICOS, 4-1BB and other undisclosed co-stimulatory targets. Heat’s ComPACT therapy has the potential to provide a product that achieves the envisioned benefits of combination immunotherapy in a single therapy, without the need for multiple independent biologic products. Heat expects to file its first IND with the ComPACT platform in 2H, 2016.

HAIFA, Israel, June 17, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, today announced that its wholly owned subsidiary, Pluristem Ltd., has been awarded 11.1 million New Israeli Shekels (approximately $2.9 million) from the Office of the Chief Scientist (OCS) of the Israeli Ministry of Economy. The grant will support R&D activities for calendar year 2015.

“We are delighted to receive the OCS grant to support clinical trials of PLX cells, and innovations in the use of serum free medium in our cell cultures,” stated Zami Aberman, Chairman and CEO of Pluristem. “This OCS award is designed to promote hi-tech and biotech R&D in Israel. Israel has emerged as a global hub for breakthrough technologies, and the OCS’s funding program contributes to this phenomenon. Pluristem is very proud to be among Israel’s leading life sciences companies.”

About the Office of the Chief Scientist and Grant Terms

The OCS, empowered by the Law for the Encouragement of Industrial Research & Development — 1984, oversees all government sponsored support of R&D in the Israeli hi-tech and bio-tech industries. This broad-spectrum support stimulates the development of innovative, state-of-the-art technologies, enhances the competitive power of the industry in the global hi-tech market, and creates employment opportunities.

According to the OCS grant terms, Pluristem Ltd. is required to pay royalties of 3% – 4% on sales of products and services derived from technology developed using this and other OCS grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three-dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

JERUSALEM, June 16, 2015 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the Russian Federal Service for Intellectual Property has granted the Company a patent for its invention, titled “Methods and Compositions for Oral Administrations of Exenatide.”

About ORMD-0901 – Oral GLP-1

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently marketed in injectable form only, and is indicated for treatment of type 2 diabetes. Exenatide induces insulin release at increased glucose levels and causes a feeling of satiety, which results in reduced food intake and weight loss. Oramed’s oral GLP-1 capsule, based on the Company’s POD™ technology, could significantly increase compliance and become a valuable tool in the treatment of diabetes.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a 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 top 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). Having completed separate Phase IIa clinical trials, the Company anticipates the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition the Company is developing an oral GLP-1 analog capsule (ORMD-0901).

ROCKVILLE, Md., June 8, 2015 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that its drug candidate RX-21101 was selected by the National Cancer Institute’s (NCI) Nanotechnology Characterization Laboratory (NCL) for its preclinical characterization program to help facilitate the advance of RX-21101 towards human clinical trials. RX-21101 is a polymer conjugated form of docetaxel that contains a signaling moiety which directs the drug into the tumor. This approach may maximize the level of docetaxel in the tumor and may minimize the level of freely circulating docetaxel in the body, which may result in increased anti-tumor activity and a reduction of adverse events.

NCI developed the NCL to facilitate the translation of promising nanotechnology-based therapeutics for the treatment of cancer, working in concert with the National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA). NCL will conduct an extensive series of preclinical studies on RX-21101 including physiochemical characterization, in-vitro cytotoxicity/hematology/immunology studies, and in vivo rodent pharmacokinetic studies. These studies, together with the additional work being performed by Rexahn scientists, will provide the foundation for filing an investigational new drug (IND) application to start Phase I clinical testing.

“We are very pleased that NCI selected RX-21101 for its NCL program. We believe RX-21101 holds the potential to address the patient population currently being treated with docetaxel in a manner that offers higher efficacy with reduced systemic side effects. Rexahn welcomes the opportunity to work with NCI to advance RX-21101 toward clinical development,” commented Rexahn’s CEO, Peter D. Suzdak, Ph.D.

CAESAREA, Israel, June 8, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, presented a Late Breaking Poster titled, “Performance of Dario Blood Glucose Monitoring System Evaluated in a Clinical Study in Compliance with the New ISO 15197:2013 Standard,” at the ADA’s 75th Anniversary Scientific Sessions.

Dr. Paul Rosman, a member of the LabStyle Innovations Scientific Advisory Board, delivered the presentation at the ADA’s Scientific Session that brings together over 14,000 participants from 124 countries. The poster revealed the results of a 368 patient Diabetes Type 1 and Type 2 study that was performed in the United States.

Results of the study, which was carried out in Ohio, showed that the Dario™ Blood Glucose Monitoring System meets the acceptance criteria of new more stringent ISO 15197:2013. 97.8% of the Dario glucose results fall within + 0.83 mmol/L (15 mg/dL) at glucose concentrations + 15% at glucose concentrations >5.5 mmol/L (>100 mg/dL).

In addition the study demonstrated that usage of the Dario Diabetes Management Solution is simple and intuitive and that the instructional material provided with the device is sufficient to allow a layperson to easily use it.

“I am very excited to have this opportunity to present the very positive results of the performance study that was done at the prestigious ADA scientific session. Dario has been proven to deliver superb accuracy and excellent patient usability which is in line with the experiences patients are having when using Dario to manage their diabetes in their daily lives.” stated Dr. Rosman.

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