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.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the “Company”) today announced that its investigational LEAPS rheumatoid arthritis vaccine candidate has been accepted for a new program of technology commercialization and niche analysis managed by Foresight Science & Technology for the U.S. National Institutes of Health (NIH). CEL-SCI’s selection into this commercialization program, including market entry strategy and launch tactics, is an extension of the Phase I Small Business Innovation Research (SBIR) grant in the amount of $225,000 awarded to CEL-SCI in July 2014 from the NIH’s National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS).

Only a select number of SBIR recipients are additionally awarded the commercialization and launch niche analysis program, which will examine the market in depth for the LEAPS rheumatoid arthritis vaccine. This analysis will include interviews with experts and end-users, recommendations for a market entry, launch tactics and revenue projections. According to Visiongain, the world rheumatoid arthritis drug market will generate revenues of $38.5 billion in 2017.

“As we advance the clinical development program for our LEAPS rheumatoid arthritis vaccine, we are very pleased that the NIH has recognized the potential market value of this product. We believe the commercialization and program niche analysis will be of value to CEL-SCI as we apply for a Phase II SBIR grant to continue to support our efforts of bringing LEAPS into human clinical trials,” stated Daniel Zimmerman, Ph.D., Senior Vice President Research and Development, Cellular Immunology.

ROCKVILLE, Md., Nov. 05, 2015 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (RNN), a clinical stage biopharmaceutical company developing next generation therapeutics for the treatment of cancer, announced today that interim clinical data from an ongoing Phase IIa study of its novel anti-cancer drug candidate, Archexin®, will be presented on Friday, November 6, 2015 at the 14th International Kidney Cancer Symposium in Miami, Florida.

“We are excited to present interim data from the ongoing Phase IIa clinical trial showing that Archexin, in combination with everolimus (Afinitor®), appears to be safe and well tolerated at the doses tested to date. We have also noted early evidence of clinical activity at low doses in patients with metastatic kidney cancer,” commented Peter D. Suzdak, Chief Executive Officer. “We look forward to completing the randomized, open-label, 2-arm dose expansion study of Archexin in combination with everolimus versus everolimus alone in order to further evaluate Archexin in metastatic renal cell carcinoma.”

CAESAREA, Israel, Nov. 11, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, announced today that it has signed an exclusive distribution agreement with one of India’s leading pharmaceutical and medical device networks, Centaur Pharmaceuticals Pvt. Ltd. As one of India’s top ranked healthcare companies, Centaur’s network includes a sales force of 1,000 covering 250,000 doctors and 250,000 retailers.

“We are proud to partner with Centaur, a company that leads the market in bringing improvements and innovation to the health system in India. They are the perfect partner to bring the Dario™ blood glucose monitoring system to the market in India to help the millions of people with diabetes to self-manage and improve their health,” said LabStyle Innovations’ President and Chief Executive Officer Erez Raphael.

According to the International Diabetes Federation (IDF) diabetes is growing to epidemic proportions in India, with over 66.8 million people diagnosed. The prevalence of diabetes in the general population is 8.6%, with some regions reported to have up to 20% prevalence.

“Diabetes is the fastest growing epidemic across the region. In India it is a very challenging disease due to our large infrastructure and resource constraints. According to the IDF there is limited availability of much needed self-management education. The Dario Diabetes Management Solution is the perfect tool for the diabetes community in India. For the first time, Dario will enable self-management and education through digital and remote monitoring,” said Mr. S D Sawant, Chairman and Managing Director of Centaur. “We are enthusiastic about bringing the cutting-edge Dario™ platform to the Indian market to assist and improve the health and the quality of care.”

PETACH TIKVA, Israel, Sept. 17, 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 the U.S. Food and Drug Administration (FDA) has granted the Company’s drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA’s Orphan Drug designation.

Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 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 oral 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.

Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug’s development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.

“We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication,” stated Can-Fite CEO Dr. Pnina Fishman. “We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients.”

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.

HAIFA, Israel, Sept. 21, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today that Pluristem and the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), completed a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the development program for PLX-R18 cells in the treatment of Acute Radiation Syndrome (ARS). ARS is caused by exposure to dangerously high levels of radiation, such as those that could occur in a nuclear catastrophe. The FDA communicated that the data presented at the meeting allow for the design of large animal studies, which are the only studies required to prove efficacy for FDA approval under the Animal Rule; this is the regulatory pathway followed when human efficacy trials are not ethical or feasible. The FDA also offered to assist Pluristem with the design of these trials. The NIAID, which has supported and conducted two earlier studies of PLX-R18 in a mouse model of ARS, communicated its interest in supporting and completing trials in large animals as well, pending protocol review by the FDA.

The FDA advised Pluristem to conduct a pilot study in large animals to determine the optimal dose of PLX-R18 as a treatment for the hematologic component of ARS. Once the optimal dose schedule is determined, a pivotal trial in large animals could commence. If successful, this trial would provide sufficient efficacy data for an application to the FDA for approval of PLX-R18 as a treatment for ARS.

“This positive meeting with the FDA is a major step forward for our PLX-R18 program, and we expect to submit a protocol to the FDA for the dosing trial in large animals as soon as possible,” said Pluristem Chair and CEO Zami Aberman. “FDA approval of PLX-R18 for ARS could generate U.S. government interest in stockpiling it for use in the case of a nuclear disaster, since PLX cell products are ideally suited for rapid initiation of treatment of large populations. Our cells do not require tissue matching prior to administration and can be administered quickly via intramuscular injection.” Mr. Aberman added, “We value our close working relationship with the NIH/NIAID, and look forward to continuing to collaborate with them.”

Previous NIH/NIAID studies of PLX-R18 in ARS

The NIH has supported and completed two mouse studies of PLX-R18 as a potential treatment of the component of ARS that affects bone marrow function. ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells and platelets, as well as to other systems and organs. Severe damage to bone marrow quickly makes victims vulnerable to life-threatening hemorrhage, infection and anemia. A recently concluded NIH/NIAID study showed that administration of PLX-R18 resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, and described the cells’ mechanism of action. The NIH/NIAID’s first study of PLX-R18 showed a substantial, statistically significant improvement in 30-day survival and overall survival of irradiated rodents given PLX-R18 versus a control.

JERUSALEM, September 24, 2015 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the Company’s patent for its invention, titled “Methods and Compositions for Oral Administrations of Proteins” has been allowed by the United States Patent and Trademark Office.

Nadav Kidron, CEO of Oramed, stated, “This is an important milestone which paves our entrance into the US diabetes market which is the largest single diabetes market worldwide.”

About ORMD-0801 Capsule for Type 2 Diabetes

ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. Orally administered insulin should bring with it enhanced patient compliance. In addition, intestinally absorbed-oral insulin actually mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.

ROCKVILLE, Md., Sept. 28, 2015 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing next generation therapeutics for the treatment of cancer, announced today that preliminary clinical data from ongoing Phase I studies of its anti-cancer compounds, Supinoxin™ and RX-3117, were presented on Sunday, September 27, 2015 in two poster presentations at the joint 18th ECCO – 40th ESMO European Cancer Congress 2015 – a biennial congress focused on improving the prevention, diagnosis, treatment and care of cancer patients, taking place in Vienna, Austria, September 25-29, 2015.

“We were pleased to have the opportunity to showcase promising preliminary data from both the Supinoxin and RX-3117 clinical programs at this prestigious cancer meeting,” commented Dr. Peter D. Suzdak, Chief Executive Officer of Rexahn Pharmaceuticals. “The initial clinical results demonstrate that both Supinoxin and RX-3117 appear to be safe and well tolerated and also show encouraging preliminary evidence of clinical activity. We believe these results underscore the unique mechanism of action of both compounds and their ability to selectively target key molecular pathways involved in cancer biology.”
Supinoxin Clinical Program

Preliminary results from the Phase I Supinoxin clinical trial were presented on September 27, 2015 by study investigator, Dr. Gail Eckhardt, Professor of Medicine/Oncology at the University of Colorado Cancer Center, in a poster presentation entitled “Single Agent Supinoxin Targeting Phosphorylated p-68 Preliminary Phase I Data.”

The results demonstrated that, at the dose levels tested to date, Supinoxin administered orally appeared to be safe and well tolerated with no Grade 3 or Grade 4 adverse events and only one unrelated Grade 2 adverse event. The most frequently reported drug related adverse events were mild nausea, vomiting and fatigue. Pharmacokinetic analyses of the current data demonstrate both a predictable and desirable pharmacokinetic profile for an orally-administered route of therapy.

Clinical evidence of single-agent activity of Supinoxin was also observed in 4 patients who showed stable disease persisting from between 255 and 497 days as of September 14, 2015. Currently, 3 of the 4 patients exhibiting stable disease remain on active treatment and continue to be followed in the study.

“Supinoxin’s novel mechanism of action targets a new biological pathway that is involved in the proliferation and metastasis of numerous types of cancers,” said Dr. Eckhardt. “We are very excited about the novelty of this approach and the potential for Supinoxin to treat historically difficult-to-treat cancers, such as triple negative breast cancer, for which there is a tremendous unmet medical need.”

Dr. Ely Benaim, Chief Medical Officer of Rexahn Pharmaceuticals, remarked “We are very encouraged by the emerging data from the Phase I study, which demonstrate that Supinoxin can be administered safely to cancer patients with advanced disease and appears to have a pharmacokinetic profile suggesting its utility as an orally administered, novel targeted therapy to treat cancer patients. Moreover, the observation of stable disease for relatively prolonged periods of time in certain patients is particularly encouraging and certainly warrants further clinical investigation. We look forward to determining the maximum tolerated dose in the current study and then using that dose to treat selected patient populations in Phase Ib/IIa clinical proof-of-concept studies with Supinoxin next year.”

Supinoxin is a first-in-class, orally bioavailable, small molecule inhibitor of a cancer protein (phosphorylated p-68) believed to play a prominent role in cancer cell development and proliferation. Supinoxin is currently being evaluated in an ongoing Phase I multi-center, dose-finding, open-label, single agent clinical study in patients with advanced or metastatic solid tumors. Patients in the study were treated once weekly for 3 weeks, with 1 week off treatment, comprising a 28-day treatment cycle.

The Phase I clinical study is designed to evaluate the safety, tolerability, dose-limiting toxicities, and maximum tolerated dose (MTD) of Supinoxin and identify a recommended phase Ib/IIa dose and dosing schedule for continued clinical development. Secondary endpoints in the study include pharmacokinetics and anti-tumor activity.

Based on the favorable safety and pharmacokinetic profile seen at the highest dose levels (575 mg and 775 mg), Rexahn has initiated a dosing schedule modification to increase patients’ daily exposure of Supinoxin. All newly enrolled patients are now receiving Supinoxin either three or five times weekly as opposed to once weekly. The new dosing paradigm will increase drug exposure, maximizing potential therapeutic activity and enable more rapid determination of the MTD for further clinical study.

HAIFA, Israel, July 27, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, today announced the publication of a scientific study regarding PLacental eXpanded (PLX) cells in the prominent peer-reviewed journal Stem Cells. The paper, titled “Mesenchymal stromal cells prevent allostimulation in vivo and control checkpoints of Th1 priming: migration of human DC to lymph nodes and NK cell activation”, describes the findings of a recent mechanism of action study conducted by independent scientists at the Berlin-Brandenburg Center for Regenerative Therapy at Charite – University Medicine Berlin. The paper was co-authored by scientists from the Charite and Pluristem.

The study demonstrated mechanisms by which PLX cells and other mesenchymal stromal cells (MSC) influence the immune system in order to modulate immune reactions and to prevent immune reactions against the cells when they are administered as an off-the-shelf product (unmatched). It was demonstrated in vitro that MSC, and in particular PLX cells, control the induction of an immune response at several points. The main target for MSC and PLX cells in this process are dendritic cells, which are the key player in inducing a T-cell immune response. Moreover, in vivo data from patients suffering from critical limb ischemia who were treated with PLX cells in a phase I/II study confirmed that HLA-unmatched PLX cells did not provoke an immune response in immunocompetent patients. These findings confirm the feasibility of using PLX cells in an off-the-shelf manner, and explain the mechanisms that make this possible.

“Our findings in this study provide novel evidence for the regulation of several checkpoints of T-cell priming by PLX cells and other MSC, via modulation of the crosstalk between myeloid dendritic cells and natural killer cells. While the complete mechanism of immunomodulation by PLX cells requires further investigation, this study demonstrates how PLX cells might inhibit the immune responses of Type 1 T helper cell,” stated the study’s Principal Investigator, Dr. Hans-Dieter Volk, Director of the Berlin-Brandenburg Center for Regenerative Therapy and head of the Institute of Medical Immunology at the Charite.

“The investigation of the interaction between unmatched PLX cells and patient immune systems is central to Pluristem’s clinical research. This research may lead to a new understanding of how PLX cells influence, and potentially heal, the immune system, thereby possibly expanding the use of PLX cells for new indications,” stated Pluristem CEO Zami Aberman. “By modulating a patient’s immune response, PLX cells could potentially help treat severe diseases of the immune system such as aplastic anemia, which has been designated as an orphan indication, autoimmune diseases such as multiple sclerosis and lupus, as well as graft versus host disease (GVHD),” Aberman added.

GERMANTOWN, MD–(Marketwired – Jul 29, 2015) – Orgenesis Inc. (OTCQB: ORGS), a cell therapy and regenerative medicine company with a novel therapeutic technology dedicated to converting a patient’s own cells into functioning insulin-producing cells as a treatment for diabetes, today announced that its wholly owned subsidiary, MaSTherCell, a Contract Development and Manufacturing Organization (CDMO) has entered into a Memorandum of Understanding with France-based TxCell (TXCL.PA) (Euronext Paris: FR0010127662 – TXCL), to manufacture clinical batches of Ovasave®, TxCell’s lead product. Ovasave is an antigen specific autologous T regulatory somatic cell therapy in development for the treatment of Inflammatory Bowel Disease. As part of the Memorandum of Understanding, MaSTherCell and TxCell also agreed to enter into discussions for the long-term clinical and commercial manufacturing by MaSTherCell of TxCell products.

Ovasave batches manufactured by MaSTherCell will be used by TxCell in its ongoing Phase 2b trial, CATS29, for the treatment of Crohn’s disease. The first clinical batches could be manufactured by MaSTherCell as soon as Q2 2016. CATS29 is a multi-center, randomized, double-blinded, placebo-controlled, multi-dose and multi-injection 4-parallel groups study. The trial has been designed to include 160 severe refractory Crohn’s disease patients. It is currently on-going in 30 study sites in 6 countries including Austria, Belgium, France, Germany, Italy, the United Kingdom, and may be extended into the U.S. The United States Food and Drug Administration recently granted Fast Track Designation to Ovasave for the treatment of moderate to severe Crohn’s disease.

“MaSTherCell is a European leader in cellular therapy products manufacturing with a significant track record in production of clinical materials. This strategic relationship with MaSTherCell is very important to TxCell,” said Stéphane Boissel, Chief Executive Officer of TxCell.

Vered Caplan, Chairperson and CEO of Orgenesis, commented, “We are pleased that MaSTherCell has entered into a substantial cell manufacturing agreement with TxCell for Ovasave, in an indication that has a clear unmet need which may best be treated through a cutting edge cell therapy like Ovasave. We look forward to working very closely with TxCell to deliver unparalleled manufacturing services for its trial.”