HAIFA, Israel, April 28, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR) today announced that its new manufacturing facility has received the European Union’s Qualified Person Declaration. With this declaration, Pluristem is now approved to use cell therapies manufactured at its state-of-the-art facility located in Haifa, Israel, in all phases of its clinical trials conducted in the European Union, including Phase I, Phase II and Phase III.

The Qualified Person inspection was conducted in line with the European Union’s Good Manufacturing Practice (GMP) legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem’s new facility, equipment, utilities, and quality management systems. Pluristem’s manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.

“This Qualified Person declaration enables us to expand our clinical site locations into any European Union member nation through each phase of our trials,” stated Zami Aberman, Chairman and CEO of Pluristem. “We believe Pluristem’s advanced, commercial scale cell manufacturing facility is one of our Company’s key strategic assets and gives us significant competitive advantage in the industry as we move our clinical development pipeline forward.”

At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem’s facility has the ability to efficiently produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.

About Pluristem’s 3D Manufacturing

Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products. Pluristem’s manufacturing facility and its commercial scale manufacturing process have received approval from the U.S. Food and Drug Administration and the Paul-Ehrlich-Institute (PEI), Germany’s health authority.

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.

Please visit the following link to read the article entitled “Infection Control” in its entirety on Page #52:  http://edition.pagesuite-professional.co.uk/launch.aspx?pbid=587773cf-29c4-46f2-9d9d-2f87bf178b5c

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.

EnergyCentral.com, an Internet publisher for the electric power and energy industry, just published an article by Shlomi Palas, CEO of Bluesphere Corporation. Bluesphere, ticker BLSP, is an energy company that develops, manages and owns clean tech waste-to-energy projects.

The article is titled, “Post State of the Union Address – Waste-to-Energy addresses all of the President’s Issues on Environment”. In the article, Palas points out that clean-energy advocates have increasingly called on the president to ditch his agnostic “all of the above” approach to energy policy and embrace what they say is a “best-of-the-above” energy policy.

One technology in the “best-of-the-above” category riding a huge wave that is sweeping the US is Waste-to-Energy. Waste-to-Energy converts waste that would normally go into landfills into clean energy. It is in its very early stages of adoption in the U.S. There is demand for Waste-to-Energy from municipalities and some of the largest companies are investing in the segment.

Bluesphere is about to break ground on its first Waste-to-Energy facility in the U.S.. The facility is backed by $17.8 million in project financing from Caterpillar and over $6 million from a clean-tech fund. Major electric utility companies Duke Energy and National Grid have signed long term power purchase agreement with Bluesphere. Waste-to-Energy technology tackles and solves three major issues which are mentioned in Obama’s speech:
– Waste-to-Energy reduces carbon pollution
– It reduces the amount of waste going into landfills
– And it contributes to Obama’s target to reduce the use of fossil oil as we generate green electricity

As a result of the President’s focus and supporting budgets, the U.S. is beginning to see a tectonic movement in a global multi-billion industry and Waste-to-Energy is at the forefront of it.

To read the entire article please visit: http://www.energycentral.com/generationstorage/environmentalemissionsandcarbonmanagement/articles/2876/Post-State-of-the-Union-Address-Waste-to-Energy-addresses-all-of-the-President-s-Issues-on-Environment

JERUSALEM, April 10, 2014 /PRNewswire/ — Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the Intellectual Property Department of Hong Kong has granted the Company’s patent for its invention, titled “Methods and Compositions for Oral Administrations of Proteins.”

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 (POD™) 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 1 diabetes (T1DM) and type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral GLP-1 analog capsule (ORMD-0901). 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 www.oramed.com

Pompano Beach, Fla., April 10, 2014 (GLOBE NEWSWIRE) — DS Healthcare Group, Inc. (NASDAQ:DSKX), a leading developer of personal care products, today announced it has signed a distribution agreement with Drogaria Iguatemi, the leading high-end retail drug store chain in Sao Paulo, Brazil. This marks the second major distribution agreement signed by DS Healthcare in Brazil’s $43 billion beauty industry. The Company’s products are experiencing robust sales growth in the Rio de Janeiro metropolitan area, as well as through DS Healthcare’s Brazilian e-commerce site.

The Sao Paulo metropolitan area has a population of 20 million, in one of the fastest growing beauty markets in the world. According to a U.S. Department of Commerce report titled, Doing Business in Brazil, “Hair care products make up the largest segment of the Brazilian cosmetics and toiletries market. Shampoo sales, both imported and locally made, constitute about 50 percent of domestic sales; they are divided evenly between Brazilian and well-known multinational suppliers.”

Drogaria Iguatemi has Sao Paulo’s most affluent chain of pharmacies. Selecting to carry only the most important brands in medicine, cosmetics, derma-cosmetics and skin care products in the world. Drogaria Igautemi has already begun retailing DS Healthcare’s products.

Director of Drogaria Iguatemi, Leonardo Diniz commented, “DS Healthcare’s product line, and specifically its hair care products are a fantastic fit for our chain. Brazilians love their hair and attach much more importance to hair health and appearance than people of other cultures. This is evidenced in the high degree of spending per capita for hair care and beauty in Brazil. We are very excited to get these products on our shelves.”

“Brazil is one of the largest markets in the world for our products. Our in-country roll out strategy there is on schedule and we are pleased with the results so far. As the leading high-end pharmacy and beauty products chain in Sao Paulo, Drogaria Iguatemi offers us an ideal retail distribution channel to launch our product lines into this very important metropolitan beauty market,” added DS Healthcare President and CEO Daniel Khesin.

According to Euromonitor, a market research firm, the Brazilian beauty industry generated $43 billion in sales in 2011, an increase of 142% over the last five years, putting it in position to overtake Japan as the world’s second-largest beauty market within several years.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that the Henry Ford Health System in Detroit, Michigan is the latest U.S. clinical center to join the Company’s Phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). CEL-SCI is currently expanding and accelerating patient enrollment in its trial. The Company expects to rapidly expand the number of clinical sites active in the U.S. As the world’s largest Phase III trial for head and neck cancer, CEL-SCI’s study is already active in dozens of clinical centers in 12 countries and is expected to expand to a total of 20 countries by the end of 2015.

CEL-SCI’s Multikine investigational cancer immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of patients. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

According to a report published by the Metropolitan Detroit Cancer Surveillance System in 2010, there were 24,651 new invasive and in situ cancers diagnosed in residents of the metropolitan Detroit area of Wayne, Oakland, and Macomb Counties. In a national study researchers estimated that more than 52,000 men and women would be diagnosed in the U.S. with head and neck cancers in 2012, according to the National Cancer Institute.

Founded in 1915 by auto pioneer Henry Ford and now one of the nation’s leading health care providers, Detroit’s Henry Ford Health System is comprised of hospitals, medical centers and one of the nation’s largest group practices, which includes more than 1,200 physicians practicing in over 40 specialties.

The Josephine Ford Cancer Institute at Henry Ford is a leader in groundbreaking techniques, offering the most advanced diagnostic testing, and multiple treatment approaches including surgery and radiation therapy. Dr. Haythem Ali, a medical oncologist, is the Principal Investigator for CEL-SCI’s study at Henry Ford. His specialties include head and neck cancer and he has published several articles in peer reviewed journals.

“This is our first U.S. clinical center to open in the Midwest. Our intention is to rapidly add more clinical research centers located across North America so that patients seeking to enroll in our immunotherapy trial may have the opportunity to access a site. We are pleased that Dr. Haythem and one of the leading healthcare providers in the country, Henry Ford Health System, have chosen to participate in our groundbreaking study,” stated CEL-SCI Chief Executive Officer Geert Kersten.

POMPANO BEACH, Fla., April 4, 2014 (GLOBE NEWSWIRE) — DS Healthcare Group, Inc. (DSKX), a leading developer of personal care products, today announced financial results for the three and twelve months ended December 31, 2013.

2013 Year-End Highlights:

• Record net revenues of $13,652,000, up 22% over 2012
• Gross margin increases to 50% in 2013 from 40% in 2012
• Gross profits increase to $6,709,000, up 50% over 2012
• Net loss narrows 11% from 2012 to $(3,225,000)
• Adjusted EBITDA, a non-GAAP financial measure, in 2013 was a loss of $(1,170,000)
• Files first patent for its proprietary hair loss formula
• Begins preparation to file Investigational New Drug application with FDA for prescription hair loss product
• Continues global expansion with launch of products in Brazil and China, two of the world’s largest beauty markets, and integrates acquired Mexican distributor
• $3.144 million fund raise in December 2013 and January 2014 strengthens balance sheet
• Cash on hand of $2,873,000 as of December 31, 2013

Fourth Quarter (Q4) 2013 Highlights:

• Q4 net revenues up 10% year-over-year to $3,059,000
• Gross margin increases to 49% in Q4 resulting in a gross profit of $1,570,000
• Net loss narrows 66% from Q4 of 2012 to $(945,000)
• Adjusted EBITDA, a non-GAAP financial measure, in Q4 was a loss of $(110,000)

“In 2013 we continued to solidify our position as the leader in innovative over-the-counter hair thinning products as evidenced by our fifth consecutive year of record top line growth. Revenue growth was driven primarily by sales of our Revita Shampoo and Spectral treatment lines that are recognized around the world for their efficacy in hair re-growth. During the year we also made a very strategic start into the prescription hair loss market, where there is a clear and underserved need for effective solutions without side effects,” stated DS Healthcare President and CEO Daniel Khesin.

Mr. Khesin continued, “We are increasing market share for our over-the-counter branded products which are now sold through over 10,000 outlets in the U.S. and internationally. In 2013 48% of our sales were from outside of the U.S. We made key market moves into Brazil, the second largest beauty market in the world, and we fully integrated our former Mexican distributor, which we acquired at the end of 2012. Sales in Mexico made a significant contribution to our revenue growth in 2013 and we believe Brazil could do the same in 2014 and beyond. Notable milestones achieved in 2013 include our efforts that led to a 5-year agreement we executed in February of 2014 with one of the world’s largest healthcare companies. Through this agreement, we will provide one of our proprietary formulations, ingredients and technology to this Fortune 500 global healthcare company for use in a topical product to be launched and distributed by them. This kind of agreement validates the recognized uniqueness and value of our innovative formulations in the market.”

“During 2014 we plan to begin the clinical development of our pharmaceutical hair loss product, which we believe addresses a $10 billion market in need of a product that works. We laid the foundations in 2013 by filing for a U.S. patent for this prescription grade formulation, retaining Aptiv Solutions as our clinical research organization, and by preparing to file our investigational new drug application with the Food and Drug Administration. If approved, we believe our product would be only the third prescription grade hair loss product and the second topical prescription grade hair loss product to receive FDA approval in the U.S.,” Khesin concluded.

For the year ended December 31, 2013, DS Healthcare’s net revenues increased to a record $13,651,661, up $2,427,237 or 22%, from $11,224,424 in 2012. Revenue increase was driven by the Company’s Mexican subsidiary acquired at the end of 2012 and the fulfillment of backlog orders from the fourth quarter of 2012. The Company’s Revita and Revita COR hair re-growth stimulating shampoos and conditioners were the primary contributors to revenues, representing 40% of total sales.

Gross margin increased to 49% in 2013 from 40% in 2012, as a direct result of the Company’s ongoing effort to reduce chemical, packaging and labor costs, while continuing to deliver effective and cutting edge products worldwide. Gross profits in 2013 grew by 50% to $6,708,619 over $4,474,767 in 2012.

Selling and marketing costs decreased by 2% to $3,747,213 in 2013 from $3,836,540 in 2012. General and administrative costs increased 47% to $6,254,170 in 2013 from $4,249,470 in 2012, driven by an increase in costs from the Company’s acquired Mexican subsidiary, non-cash depreciation charges, and cash and non-cash professional fees for accounting and financial services, which were partially offset by a 56% reduction in bad debts as a result of improved collection results.

DS Healthcare’s net loss narrowed by 11% to $(3,225,289) or $(0.25) per basic and diluted share in 2013 from $(3,623,109) or $(0.33) per basic and diluted share in 2012, driven by record revenues and higher gross margins, partially offset by higher general and administrative costs.

On December 31, 2013 the Company had cash and cash equivalents of $2,872,946 and working capital of $4,049,402. Total stockholders’ equity on December 31, 2013 was $5,632,830 up 36% over December 31, 2012.

For the three months ended December 31, 2013, DS Healthcare’s net revenues were $3,058,626, an 11% increase over net revenues of $2,768,573 in the fourth quarter of 2012. The revenue increase was driven by increased demand for DS Healthcare’s products and the acquisition of the Company’s Mexican subsidiary.

Gross margin increased to 49% in the fourth quarter of 2013 from 7% in the same period of 2012, when the Company sustained a number of one-time charges that had downward pressure on the margins for that quarter. Fourth quarter 2013 margin also benefitted from increased efficiency, better formulations and improved packaging sources. Gross profits grew by 761% to $1,570,423 in the fourth quarter of 2013 from $182,304 in the same period of 2012.

Selling and marketing costs decreased by 30% to $913,951 in the fourth quarter of 2013 from $1,300,342 in the same period of 2012. General and administrative costs declined by 5% to $1,723,994 in the fourth quarter of 2013 from $1,639,480 in the same period of the prior year.

For the fourth quarter of 2013, DS Healthcare’s net loss narrowed by 67% to $(944,860) or $(0.07) per basic and diluted share from $(2,774,323) or $(0.23) per basic and diluted share in fourth quarter of 2012, driven by increased sales, improved gross profit margins and an overall restructuring of expenses.