Pluristem Says United Therapeutics to Begin Phase 1 Trial of PLX-PAD; Vertex Announces Initiation of VX-809 Print E-mail
By Staff and Wire Reports   
Tuesday, 26 February 2013 19:00

Below is a look at some of the headlines for companies that made news in the healthcare sector on February 26, 2013.

Pluristem Therapeutics Inc. (Nasdaq: PSTI) a leading developer of placenta-based cell therapies, announced afollowing favorable preclinical studies, United Therapeutics Corporation intends to begin a human Phase I clinical trial in Australia using Pluristem's PLacental eXpanded (PLX-PAD) cells in patients diagnosed with Pulmonary Arterial Hypertension (PAH) upon approval by the Australian regulatory authorities.

On June 20, 2011 United Therapeutics and Pluristem entered into a licensing agreement whereby United Therapeutics will develop, market and sell Pluristem's PLX-PAD cells for PAH.

PAH is characterized by abnormally high blood pressure in the arteries of the lungs and leads to an increased workload on the right side of the heart.

In the proposed clinical trial, PLX-PAD cells will be injected intravenously (IV) into humans for the first time, opening potential new fields for PLX cells.


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Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
announced the initiation of a global pivotal Phase 3 development program for fixed-dose combinations of VX-809 (lumacaftor) and ivacaftor in people with cystic fibrosis (CF) who have two copies (homozygous) of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Vertex plans to conduct two 24-week Phase 3 studies to support approval of the combination of VX-809 and ivacaftor in people with CF ages 12 and older. The studies, TRAFFIC and TRANSPORT, will each include two treatment groups that will evaluate VX-809 (600mg QD or 400mg q12h) in combination with ivacaftor (250mg q12h) compared to a placebo group. Vertex expects to obtain 24-week safety and efficacy data from both studies and to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), pending study results.

Vertex also plans to conduct a pharmacokinetics and safety study to evaluate VX-809 in combination with ivacaftor in children with CF ages 6 to 11 who have two copies of the F508del mutation. The company expects to use the data from this study for subsequent registration in children ages 6 to 11 in the United States and is continuing discussions with European regulatory agencies for patients in this age group.

Vertex will host a conference call for investors and media today, February 26, 2013 at 5:15 p.m. EST, to discuss the company's Phase 3 development plan.

“This Phase 3 development program is a significant advance in our efforts to develop new medicines that treat the underlying cause of cystic fibrosis for people with the most common type of the disease,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “Importantly, these studies will evaluate two doses of VX-809 in combination with ivacaftor for 24 weeks, and pending data, enable submissions to U.S. and European regulatory authorities. People with CF are in urgent need of new treatments, and we are committed to advancing this combination through Phase 3 development as quickly as possible.”

Cystic fibrosis is a rare, life-shortening genetic disease for which there is no cure. Approximately 70,000 people worldwide have CF, including 30,000 in the United States and 35,000 in Europe. Globally, nearly half of those with CF have two copies of the F508del mutation.


Also Tuesday:


3DIcon Corporation (OTCBB: TDCP),
a developer of volumetric, three-dimensional display technologies, and Digital Light Innovations (privately held), a full service company that designs, develops and produces products based on DLP® technology from Texas Instruments, announced that they have signed a Letter Agreement under which Digital Light Innovations (DLi) has agreed to bundle 3DIcon's Pixel Precision software with its DLi41xx Series of development kits for the Texas Instruments DLP® projection imaging technology as part of an existing and now expanded exclusive distribution agreement.

Applied Nanotech Holdings, Inc. (OTCBB: APNT)
announced that its subsidiary, EZDiagnostix ("EZDx"), has retained WoodRock Securities, L.P., a Houston, Texas-based investment banking firm ("WoodRock"), to assist the company in arranging capital.

Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)
, a specialty biopharmaceutical company, today announced financial results for the fourth quarter and the year ended December 31, 2012.  

Baxter International Inc. (NYSE:BAX)
today announced that the company has submitted a biologics license application (BLA) supplement to the U.S. Food and Drug Administration (FDA) for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, announced today that it launched the EPIC V-Series™ veterinary soft-tissue diode laser, at the 85th Western Veterinary Conference held this past February 18-20 in Las Vegas, Nevada.

Bio-Rad Laboratories, Inc. (NYSE: BIO) (NYSE: BIO.B),
a multinational manufacturer and distributor of life science research and clinical diagnostic products, announced financial results today for the fourth quarter and fiscal year ended December 31, 2012.

China Cord Blood Corporation (NYSE: CO)
("CCBC" or the "Company"), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced its preliminary unaudited financial results for the third quarter and first nine months of fiscal year 2013, which ended December 31, 2012.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer, is scheduled to present at Cowen and Company 33rd Annual HealthCare Conference on March 4, 2013 at 3:30 pm Eastern Time at the Boston Marriott Copley Place in Boston, MA.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious orphan lung diseases that are often life-threatening, today announced that members of Insmed's management team will be presenting the Company's corporate overview at the following investor conferences in March.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the Raymond James 34th Annual Institutional Investors Conference at the JW Marriot Grande Lakes in Orlando.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ)
today announced financial results for the full year and fourth quarter ended December 31, 2012.

LED Medical Diagnostics Inc. (TSX VENTURE:LMD) (OTCQX:LEDIF) (FRANKFURT:LME) ("LED Medical", "the Company"), a developer of tissue visualization detection technologies for the medical industry, is pleased to announce that today it began trading on the OTCQX International (symbol: "LEDIF"), a segment of the OTCQX® marketplace reserved for high-quality, non-U.S. companies listed on a qualified stock exchange in their home country.

Medicago Inc. (TSX: MDG; OTCQX: MDCGF)
, a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that the Company will be presenting at the following upcoming U.S. investor conferences.

NuVasive, Inc. (NASDAQ: NUVA),
a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is proud to announce that the very first eXtreme Lateral Interbody Fusion (XLIF®) procedures were performed yesterday and today at two different hospitals in Japan.

Omnicell, Inc. (NASDAQ: OMCL)
, a leading provider of medication and supply management solutions and analytics software for healthcare facilities, today announced they will present at the Cowen and Company 33rd Annual Health Care Conference at the Boston Marriott Copley Place in Boston, Mass.

Pall Corporation (NYSE:PLL)
today launched the Sentino Filter Dispenser to simplify membrane handling and maximize workflow in high throughput microbiology testing laboratories.

The Pulse Beverage Corporation (OTCQB: PLSB)
("Pulse"), makers of PULSE® brand of functional beverages and Cabana™ 100% Natural Lemonade, today congratulated Advisory Board Member, Dr. Pam Peeke, MD, MPH, FACP, on her NY Times Bestseller, "The Hunger Fix."

Response Biomedical Corp. ("Response or the Company") (TSX:RBM) (OTCBB:RPBIF)
is pleased to announce that Mr. Darby L. Darilek joined the Company on February 25, 2013 as its Director of U.S. Sales.

Savient Pharmaceuticals, Inc. (NASDAQ: SVNT)
announced today that the Company's fourth quarter and year-end 2012 financial results will be released prior to the market open on Tuesday, March 19, 2013.

Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today its financial results for the year ended December 31, 2012.

Sunshine Biopharma Inc. (OTCBB: SBFM)
, a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, is pleased to provide an update on the progress of the IND-Enabling studies of Adva-27a, the Company's flagship oncology drug candidate.

Synthetic Biologics, Inc. (NYSE MKT: SYN)
, a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that Brad Spellberg, M.D., joined the Company's Scientific Advisory Board.

Vasomedical, Inc. ("Vasomedical") (OTC BB: VASO)
, a diversified medical technology company specializing in the design, manufacture and sale of medical devices for noninvasive cardiology including EECP® Therapy systems - the gold standard of ECP therapy, and ECG Holter and Ambulatory Blood Pressure monitoring products, will attend and exhibit at the American College of Cardiology's Annual Scientific Session from March 9-11, 2013 in San Francisco, California.

Verenium Corporation (Nasdaq: VRNM)
, a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced that Michael Zak will be leaving its Board of Directors effective March 31, 2013, and that Holger Liepmann will be appointed to its Board of Directors, also effective March 31, 2013.




"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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