HAIFA, Israel, Feb. 18, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today the positive results of a recently completed trial conducted by the U.S. National Institutes of Health (NIH) to evaluate PLX-R18 cells to treat bone marrow damaged by exposure to high levels of radiation, such as can occur after a nuclear disaster. Injection of PLX-R18 cells into muscle, as compared to a placebo, 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. The data also suggested that the treatment may potentially be able to shorten time to recovery. High levels of radiation can destroy the body’s ability to produce these three blood lineages, and rapidly regaining that capacity is a key factor in surviving the hematologic component of acute radiation syndrome (ARS), a condition caused by high-dose irradiation that can involve severe, sometimes lethal damage to the bone marrow as well as other physiologic systems and organs.

The objective of this latest trial was to investigate the mechanism of action behind the significant improvement in survival in irradiated mice treated with PLX-R18 that was demonstrated in the NIH’s first efficacy study. The results of the current study indicate that intramuscular administration exerts a systemic healing effect on bone marrow, lending further support to the concept that Pluristem’s cells work systemically via secretion of therapeutic proteins, although the cells themselves remain in the muscle into which they were initially injected. While additional animal trials are needed prior to U.S. Food and Drug Administration (FDA) approval of PLX-R18 for use in ARS, no human trials would be required because product development is conducted under the FDA’s Animal Rule.

“Our PLX-R18 cell product was developed and targeted to become a strong candidate for government procurement programs designed to protect the population in the case of exposure to dangerous levels of radiation. PLX-R18 cells are an off-the-shelf cell therapy product with a long shelf life. They do not require matching before use and can be administered through intramuscular injection. These features are important to facilitate rapid initiation of treatment on a large scale. The study results also support Pluristem’s unique approach of injecting cells intramuscularly to enable the cells to remain in the body long enough to respond to signals from damaged tissues and adapt their therapeutic secretion profiles accordingly,” stated Zami Aberman, Chairman and CEO of Pluristem.

“We have had a productive working relationship with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which has independently conducted its studies with PLX-R18 cells provided by Pluristem,” Aberman added.

Pluristem is developing PLX-R18 cells for other potential indications including enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of bone marrow deficiency. Trials for this indication are ongoing at Case Western University and Hadassah Medical Center. Data from the NIH studies in ARS are expected to benefit Pluristem’s development of its hematology program.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced the Ministry of Health Malaysia has cleared the Company to commence patient enrollment for its Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Malaysia. Malaysia is the 20th country to approve CEL-SCI’s Phase III trial, which now has over 350 patients enrolled.

“Our plan called for having the trial cleared and conducted in a total of 21 countries, the United States plus 20 other countries. We are almost there,” stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine Phase III Study

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 improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.

DURHAM, N.C. and SAN DIEGO, Feb. 18, 2015 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (“Heat”) (HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, and OncoSec Medical Inc. (“OncoSec”) (ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced that they have entered into an agreement to evaluate the combination of the immunotherapy approaches developed by each company.

Under the agreement, Heat and OncoSec will jointly evaluate the preclinical efficacy of Heat’s proprietary gp-96-Ig based ImPACT immunotherapy platform using OncoSec’s core technology, ImmunoPulse, an investigational stage intratumoral DNA delivery platform.

“We are excited to initiate this collaboration with OncoSec, one of the leaders in the field of intratumoral DNA delivery,” said Taylor Schreiber, MD, PhD, Heat’s Vice President of Research and Development. “This collaboration with OncoSec reflects our desire to expand Heat’s ImPACT platform into DNA-based immunotherapies to stimulate immunity to both shared and private tumor antigens without introducing the complexities associated with personalized therapies,” Dr. Schreiber added.

“In this collaboration we will evaluate the efficacy of Heat’s proprietary DNA constructs with OncoSec’s clinical stage electroporation platform,” said Robert H. Pierce, MD, OncoSec’s Chief Scientific Officer. “Heat’s ImPACT platform is a unique approach that specifically activates tumor specific cytotoxic T-cells. We expect it will be effective with OncoSec’s proprietary intratumoral delivery platform that has already shown promising clinical activity in both local and distant tumors in patients with metastatic melanoma,” Dr. Pierce stated.

Heat and OncoSec are exploring this combination as part of their ongoing strategy to expand the application of their technologies to benefit cancer patients with unmet medical needs. Heat has two clinical stage programs based on the ImPACT platform, viagenpumatucel-L (HS-110) in a Phase 2 clinical trial in patients with non-small cell lung cancer and vesigenurtacel-L (HS-410) in a Phase 2 clinical trial in patients with non-muscle invasive bladder cancer. OncoSec’s core platform, ImmunoPulse, which is based on the intratumoral delivery of DNA IL-12, is currently in Phase 2 clinical trials, investigating the approach for treatment of metastatic melanoma, head and neck cancer, triple negative breast cancer, and cutaneous T-cell lymphoma.

PETACH TIKVA, Israel, Feb. 4, 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, announced today that all patients enrolled in its Phase II/III psoriasis trial for the Company’s drug candidate CF101 have completed the study’s 32 week treatment protocol. The trial has been completed and the final data is ready for analysis. The Company plans to publish top line results by the end of March 2015. Interim results from this Phase II/III trial and final results from the prior Phase II trial for CF101 in psoriasis were both positive.

“Following a thorough analysis of the data over the coming weeks, we look forward to announcing top line results on the efficacy and safety of CF101 in the treatment of moderate-to-severe plaque psoriasis. If these results are in line with the previously published favorable interim data, then we believe CF101 could offer a much-needed treatment alternative to patients living with psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.

The psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. According to Global Data, the psoriasis treatment market was worth $3.6 billion in 2010 and is forecast to grow to $6.7 billion by 2018.

This Phase II/III double-blind, placebo-controlled study is designed to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis. Can-Fite enrolled 326 patients through 17 clinical centers in the U.S., Europe, and Israel. The first study cohort was comprised of three arms with patients receiving: 1 mg of CF101; 2 mg of CF101; and placebo. All patients receiving placebo were switched to either 1 mg or 2 mg of CF101 after 12 weeks. The primary efficacy endpoints are a statistically significant improvement in standard measures used by dermatologists to assess psoriasis including the Psoriasis Area Sensitivity Index (PASI) score and the secondary end points among others are the Physicians’ Global Assessment (PGA) score as well as various safety parameters.