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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.

Sneakerheads will get a kick out of the Brooklyn Museum’s latest exhibition which chronicles the history and impact of a piece of footwear that is largely responsible for the commercialization of athletics; a shoe that has transcended both race and status to create a culture all its own; the sneaker. Host Annamaria Stewart sat down with Lisa Small, curator of “The Rise of Sneaker Culture” exhibition, to talk about curating the exhibit, how the Jordan Brand reached icon status, the transition from sportswear to fashion, and the preservation of collectible sneakers.

This episode is currently airing on ClearVision, an innovative in-airport TV network which features the best entertainment, news, music, and sports programming for travelers.

This series is part of the Huffington Post Outspeak Network.

www.BrooklynMuseum.org
The Rise of Sneaker Culture
July 10 – October 4 2015

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.”

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.