HAIFA, Israel, Nov. 13, 2013 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA), has approved Pluristem’s Investigational New Drug (IND) Application to conduct a Phase II study using PLX-PAD cells for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).

The IND approved by the MFDS mirrors INDs already approved by regulators in the USA, Germany and Israel. South Korea will be the fourth country participating in this multi-national trial involving the use of PLX-PAD in IC. CHA Bio&Diostech Co., Ltd. (KOSDAQ:KS), Pluristem’s South Korean partner, will fund the trial and conduct it in its healthcare facilities.

“Pluristem’s ability to extend our Phase II study of IC into South Korea is important for several reasons,” commented Zami Aberman, Pluristem’s Chairman and CEO. “Partnering with CHA Bio to conduct the clinical trial in their hospitals will accelerate the enrollment and strengthen our relationship with our South Korean partner. Additionally, Pluristem is proud of the fact that our PLX-PAD cells are the first placental-derived allogeneic cells allowed to be imported into South Korea. We at Pluristem believe this is a validation of Pluristem’s expertise in cell therapy in general and PLX potential cell therapy in particular.”

About the Study

Pluristem’s Phase II study of IC is a randomized, placebo-controlled trial that will evaluate the safety and efficacy of two courses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol targets enrollment of 150 patients with IC: Fontaine class IIb, Rutherford category 2-3.

The primary efficacy end point of the trial is the change in the maximal walking distance from baseline during an exercise treadmill test. Secondary endpoints are hemodynamic and quality of life measurements. Safety parameters are also being assessed.

About Intermittent Claudication

IC is a subset of PAD caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, such as aching, cramping, numbness or a sense of fatigue classically in the calf muscle, which occurs during exercise, such as walking, and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients and representing a cost of approximately $2.5 billion annually to the National Healthcare Bill (References:The SAGE Group and HCUP 2007 Inpatient Data).

About CHA Bio&Diostech

CHA Bio&Diostech Co., Ltd. is a leading biopharmaceutical company headquartered in South Korea; its R&D focuses on stem cells, cell therapeutics, medical device, and new drug development. The company is a member of CHA Health Systems Group, which is comprised of a medical university, medical centers and hospitals located in the US and Korea with in excess of two thousand beds under care, stem cell research centers, personal & preventive medicine, and bio venture divisions. CHA Bio&Diostech has multiple stem cell R&D pipelines in therapeutic areas including Stargardt’s disease, age-related macular disease, Parkinson’s disease, Alzheimer disease, Cerebral Palsy and glioblastoma in mid- to late-stages of development. With its extensive experience and research infra structure, CHA Bio&Diostech has built up multiple strategic relations with major research institutions in the fields of stem cell research and infertility. For more information visit www.chabio.com, the content of which is not part of this press release.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental 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.

BALTIMORE, MD–(Marketwired – Oct 28, 2013) – Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, announced today that it has initiated research coverage of WhereverTV Broadcasting Corp. (OTC Pink: TVTV), a low-cost net generation subscription television provider offering customers a portable television platform that enables subscribers to view live channels anywhere in the world.

WhereverTV is poised to change the way consumers across the globe access and watch live television and video programming. The Company is leveraging the fast-growing OTT (over the top) platform approach and a unique, proprietary Global Interactive Program Guide to emerge as a leader in the global online television and video market. Industry estimates suggest that this market will grow from $3.8 billion in 2010 to $28.9 billion in 2017.

In the Goldman Opportunity Research report on the Company, analyst Rob Goldman outlines his investment thesis.

“The OTT market is enjoying such unprecedented growth that some industry experts predict that Internet TV will be larger than Facebook and Twitter combined by 2017. With 150,000 free subscribers in 189 countries and more than 1,000 channels, WhereverTV has an enviable head start on potential Internet TV competitors. Given its positioning and unique programming approach, along with the growth of the OTT market, we believe the stock will enjoy a huge rise in conjunction with the execution of subscriber and programming milestones next year.”

This press release contains excerpts of our most recently published research report on WhereverTV. To view the sponsored research report, disclosures and disclaimers, or to download the report in its entirety, please visit www.goldmanresearch.com.

About Goldman Small Cap Research: Led by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces sponsored and non-sponsored small cap and micro cap stock research reports, articles, daily stock market blogs, and popular investment newsletters. Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.

A Goldman Small Cap Research report, update, newsletter, or article is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed. Please read all associated full disclosures, disclaimers, and analyst background on our website before investing. Neither Goldman Small Cap Research nor its parent is a registered investment adviser or broker-dealer with FINRA or any other agency. To download our research, view our disclosures, or for more information, visit www.goldmanresearch.com.

About WhereverTV Broadcasting Corp. (OTC Pink: TVTV): WhereverTV Broadcasting Corp. is the next generation subscription television service, providing consumers with licensed, live-streaming programming identical to existing cable & satellite providers through the Internet via an over the top (OTT) platform. WhereverTV provides a subscription TV over internet service that is an alternative to traditional cable and satellite services, with the added benefits of personalization and portability across many of the most popular mobile and fixed web connected devices. The WhereverTV platform manages licensed and free to air content across these devices and unlimited geographies wherever there is internet connectivity.

For more information, visit the Company’s website: www.wherever.tv.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) announced today that it has received approval from the Health Protection Administration, Ministry of Health, of the Croatian Republic to begin enrollment of subjects into the Phase III clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Croatia is the ninth country into which CEL-SCI has expanded its global Phase III trial. The trial is expected to be conducted in about 100 clinical centers worldwide. CEL-SCI expects to enroll approximately 40 patients in Croatia through four clinical centers.

CEL-SCI plans to accelerate enrollment in its Phase III clinical trial for Multikine by adding a large number of clinical centers in the eight countries where approval to start the trial was previously received and by adding new countries and centers around the world. These new centers are in addition to the Phase III clinical centers run by CEL-SCI’s partners (Teva, Israel and Orient Europharma, Taiwan).

“We are truly seeing major progress in advancing our study since engaging the two new CROs Ergomed and Aptiv Solutions, following our dismissal of the prior CRO that was managing the study, inVentiv, for lack of performance. Ergomed, which is responsible for about 95% of the patient enrollment in the trial, has invested $10 million of its own funds in the Phase III trial and, since then, has invested another $6 million in two other Multikine collaborations with CEL-SCI. Both CROs understand the potential of our science and share our vision, commitment, and diligence to bring this groundbreaking immunotherapy to market,” stated CEL-SCI CEO Geert Kersten.

On November 5, 2013 CEL-SCI announced that a second interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine investigational new drug immunotherapy was completed by the Independent Data Monitoring Committee (IDMC). The Committee, which is comprised of world class leaders in head and neck cancer, concluded that the data raised no safety concerns, and recommended that the Phase III study continue unmodified.

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant, 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.

CEL-SCI’s lead investigational therapy, Multikine, is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved by regulatory agencies (e.g. FDA) for use following completion of our clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that aims to employ our body’s natural ability to fight tumors.

On October 31, 2013 CEL-SCI announced that it had initiated an arbitration claim against inVentiv Clinical, LLC (f/k/a PharmaNet, LLC and PharmaNet GmbH (f/k/a PharmaNet AG)). CEL-SCI initially retained inVentiv Clinical to conduct the Phase III clinical trial of Multikine. CEL-SCI terminated inVentiv in or about April 2013 and replaced it with two clinical research organizations, Aptiv Solutions, Inc. and Ergomed Clinical Research Ltd. CEL-SCI’s arbitration claim is initiated under the Commercial Rules of the American Arbitration Association alleging (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud, and seeks at least $50 million in damages.

About CEL-SCI Corporation

CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body’s natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

For more information, please visit www.cel-sci.com.

JERUSALEM, November 12, 2013 /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 the last patient has left the clinic from its U.S. FDA Phase 2a safety study for ORMD-0801, an oral insulin capsule based on the Company’s platform Protein Oral Delivery (POD™) technology.

The Phase 2a trial, which enlisted 30 type 2 diabetes patients in an in-clinic setting for a seven-day period, was implemented in response to FDA feedback requesting a safety study on ORMD-0801 prior to initiating a larger multi-center trial in the US.

“We are thrilled to announce the last patient out of our Phase 2a clinical trial under the FDA. We look forward to announcing the results,” said Oramed CEO Nadav Kidron.

About ORMD-0801 Oral Insulin

Oramed’s ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite. Moreover, orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream. For more information on ORMD-0801, the content of which is not part of this press release, please visit http://oramed.com/index.php?page=14

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top research 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) currently in Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), with trials on healthy volunteers (Phase 1b) and T2DM patients (Phase 2a) underway. Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. The company’s corporate and R&D headquarters are based in Jerusalem.

For more information, the content of which is not part of this press release, please visit http://www.oramed.com