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HAIFA, Israel, April 22, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that Company executives are actively participating in a series of meetings in Washington D.C. regarding proposed legislation that may impact the future of cell therapy and regenerative medicine in the U.S.

“These initiatives are a very important effort by Pluristem, in collaboration with other industry thought leaders, to help bring about a legislative, funding, and reimbursement environment that can accelerate the commercialization of breakthrough cell therapies which have the potential to transform the lives of patients in need,” stated Pluristem CEO, Zami Aberman.

Alliance for Regenerative Medicine (ARM) Legislative Fly-In on April 29, 2014
Dr. William Prather, Senior Vice President Corporate Development, and Dr. Karine Kleinhaus, Divisional Vice President North America, will join fellow ARM members including patient advocacy organizations, research institutions and other regenerative medicine-focused companies at the organization’s annual Legislative Fly-In. This event is dedicated to meeting with key members of Congress and Administration officials to describe the immense near-term potential of regenerative medicine and the need for legislation and policies that support the development of life saving therapies. ARM supports an important bipartisan bill, the Regenerative Medicine Promotion Act of 2014, which has been introduced in the Senate and calls for a U.S. national strategy to support regenerative medicine. Dr. Prather currently serves on ARM’s Committee for Government Relations & Policy, Committee for Reimbursement, and the Sub-committee for Centers for Medicare & Medicaid Services Reimbursement. Dr. Kleinhaus serves on ARM’s Committee for Capital Formation.

Michael Werner, Executive Director of ARM, stated, “Regenerative medicine represents the single most promising new approach to mitigating the human and economic costs of disease, and changing the course of human health. Pluristem, which pioneered promising cell therapies for a number of indications, has played a vital role in advocating for regenerative medicine within the biotech community and we are pleased that they are actively involved with ARM to move the entire industry forward. To date, ARM has worked with the White House, the U.S. Food & Drug Administration, National Institutes of Health, National Institute of Standards & Technology and members of Congress to further define and promote adoption of a national strategy for regenerative medicine.”

U.S. Food and Drug Administration (FDA) Meeting on March 31, 2014
Dr. Ohad Karnieli, Pluristem’s Vice President of Development and Manufacturing met with representatives of the U.S. Food and Drug Administration at a public workshop titled, “Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products.” Participants in this meeting included key opinion leaders from industry as well as organizations advocating for standards and guidelines that can advance regenerative medicine, including Pluristem. Advocacy Organizations participating in the meeting included Alliance for Regenerative Medicine (ARM), International Society for Cellular Therapy (ISCT), American Association of Blood Banks (AABB), National Institute of Standards and Technologies (NIST), and The United States Pharmacopeial Convention (USP). Dr. Karnieli currently serves on ARM’s Science and Technology Committee and is Chair of the ISCT’s Process and Product Development Committee.

ROCKVILLE, Md.–(BUSINESS WIRE)–

Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced promising preclinical results for RX-21101, the Company’s first development candidate derived from its Nano-Polymer-Drug Conjugate System (NPDCS) platform. Results of the study were presented in a poster titled, “Synthesis of targeted docetaxel-polymer conjugate and its anti-tumor efficacy,” at the American Association for Cancer Research (AACR) Annual Meeting 2014 held earlier this month.

The preclinical study was conducted by Rexahn in collaboration with the University of Maryland and Ohio State University, and evaluated the effect of RX-21101 in both in vitro human cancer cell lines and in vivo mice xenograft tumor models using human cancer cell lines. Results of the preclinical studies were the following:

RX-21101 showed complete tumor growth inhibition, enhanced tumor regression, and extended survival in mouse xenograft models without significant changes in body weight compared to intravenously administered docetaxel
The maximum tolerated dose of RX-21101 in mice was more than 150 mg/kg, which is much higher than that of free docetaxel (~25 mg/kg)
RX-21101 inhibited the proliferation of a variety of human cancer cells in the in vitro study
The high water solubility of RX-21101 eliminates the need of toxic co-solvents that are used with systemically administered docetaxel
This study demonstrated that RX-21101 is a promising anti-tumor development candidate with reduced toxicity and prolonged survival
“We are very encouraged by these preclinical findings, which showed that RX-21101 can inhibit tumor growth, increase tumor regression, and decrease the toxicity normally associated with a chemotherapeutic drug. Drug candidates developed on the NPDCS platform represent a clinical development approach for Rexahn with low risk, as we work to improve upon FDA approved anticancer compounds that are already widely used. We believe that our NPDCS platform could offer opportunities to co-develop and introduce new and improved versions of chemotherapeutic drugs that currently are, or are soon to become generic,” commented Rexahn’s CEO, Peter D. Suzdak, Ph.D.

Rexahn’s NPDCS platform combines existing chemotherapeutic agents with a proprietary polymer carrier that contains a targeting moiety which directs the drug directly into the tumor. This approach minimizes the levels of freely circulating anti-cancer agents in the body, which can reduce potential adverse events, and maximizes anti-tumor activities by accumulating the drug in the cancer tumor. NPDCS is a broad platform that has the potential to generate multiple development candidates for Rexahn going forward.

RX-21101 is a polymer conjugated form of docetaxel, a common chemotherapy agent that is now generic but is marketed worldwide under the trade name Taxotere® and had annual sales of $3.1 billion when still under patent. Docetaxel is used in the treatment of breast, ovarian, prostate, and non-small cell lung cancer.

CEL-SCI Corporation (NYSE MKT: CVM), a late-stage oncology company, today announced that the Company is a Gold Sponsor of the European Congress on Head and Neck Oncology (ECHNO 2014), which will be held in Liverpool, England from April 24th through 26th, 2014. CEL-SCI will sponsor a symposium regarding its investigational immunotherapy candidate Multikine®* (Leukocyte Interleukin, Injection) and its ongoing Phase III head and neck cancer trial with Multikine. Company representatives will be available at conference booth #10.

In Europe alone CEL-SCI currently has 32 clinical sites participating in the Phase III clinical trial and plans to increase this number to 50 to 60 sites. The trial, which is the largest Phase III study for head and neck cancer in the world, is designed to include a total of about 100 sites in Europe, Asia, the Middle East, and North America.

ECHNO is the European Head and Neck Cancer Society’s meeting which is held every two years. At ECHNO 2014 an emphasis has been placed on addressing the need for a multidisciplinary approach to facilitate cooperation between the various clinical and research specialties involved in the management of head and neck cancer. ECHNO 2014 will provide attendees with the latest research and techniques in the ongoing effort to improve the lives of patients everywhere.

On Thursday April 24th from 13:30 to 14:30 local time, CEL-SCI executives, along with one of the principal investigators of its Phase III trial, will participate in a CEL-SCI hosted symposium and discussion on its Multikine Phase III clinical trial for head and neck cancer. The program will feature an overview of the Phase III head and neck cancer trial by Dr. Talor, Chief Scientific Officer of CEL-SCI, and a discussion of the clinical experience with Multikine by Professor Raphael Feinmesser, MD, Chairman of the Department of Otolaryngology Head & Neck Surgery at the Rabin Medical Center, Israel, and a Principal Investigator in the Multikine Phase III study.

“Our ECHNO 2014 presentation to many of the world’s leading experts in head and neck cancer comes at a pivotal time for our Phase III trial. Under the guidance of the new Clinical Research Organizations (CROs), we have accelerated the pace of the trial through a rapid increase in the number of participating clinical sites and a very substantial increase in patient enrollment. We expect that many of the investigators participating in our trial will be attending the conference and we look forward to a very meaningful exchange amongst the clinicians regarding their experience with Multikine. As we continue to expand our trial in Europe and beyond, ECHNO will be a great opportunity to interact with additional physicians and clinical centers interested in taking part in our study,” stated CEL-SCI Chief Executive Officer Geert Kersten.