Pluristem Receives Key 3D Cell Expansion Patent in Australia; OncoMed Pharma Initiates Second Phase 1b Clinical Trial for OMP-54F28 (Fzd8-Fc) Print E-mail
By Staff and Wire Reports   
Tuesday, 18 February 2014 19:45

Below is alook at some of the headlines for companies that made news in the healthcare sector on February 18, 2014.
Pluristem Therapeutics, Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced it has been granted a new patent by the Australian Patent Office. Patent #2007228341 covers the method and composition of matter for three-dimensional (3D) expansion of placental or adipose (fat) stromal cells, Pluristem's key technology platform. Patent claims also include methods of treatment using placental cells for numerous diseases including graft vs. host disease (GvHD), heart disease, stroke, burns, loss of tissue, loss of blood, anemia, and autoimmune disorders. Patents with similar claims have also been granted to Pluristem in Russia and in South Africa. This marks Pluristem's third patent issued in Australia and its 28th patent issued worldwide.

Pluristem's PLacental eXpanded (NYSE: PLX) PAD cells have been approved for a Phase I study in Australia for the treatment of Pulmonary Arterial Hypertension (PAH). United Therapeutics will be conducting the trial under a licensing agreement with Pluristem.

"Australia represents a significant and attractive healthcare market for the largest biotech and pharmaceutical companies. Because this patent covers manufacturing methods for producing commercial quantities of cells, it is very valuable intellectual property for Pluristem and the patent can be a key asset for potential partnership and licensing opportunities for us in Australia," stated Zami Aberman, Chairman and CEO of Pluristem.

Pluristem's Australian patent announced on January 8, 2014 covers the use of adherent placental cells for the treatment of ischemia, which is a restriction of blood supply to tissues, and for treatments of conditions requiring connective tissue repair or regeneration.

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OncoMed Pharmaceuticals (Nasdaq: OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that it has started a multi-center Phase 1b clinical trial of OMP-54F28 (Fzd8-Fc) with sorafenib (Nexavar®) in hepatocellular cancer (HCC). OMP-54F28 is a first-in-class Wnt-pathway-targeting decoy receptor and is part of OncoMed's collaboration with Bayer Pharma AG (Bayer). This is the second of three Phase 1b trials for OMP-54F28 to begin patient enrollment; earlier this year OncoMed initiated a Phase 1b of OMP-54F28 with nab-paclitaxel (Abraxane®) and gemcitabine in pancreatic cancer.

The Phase 1b clinical trial is a dose-escalation study of OMP-54F28 in combination with sorafenib in patients with first-line locally advanced or metastatic HCC. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for OMP-54F28 in combination with sorafenib. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of OMP-54F28, as well as the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.

Safi Shahda, M.D., Assistant Professor of Clinical Medicine at Indiana University in Indianapolis, IN, is the principal investigator who treated the first patient enrolled in this study. Dr. Shahda commented, "Hepatocellular cancer is a devastating form of liver cancer that is a significant cause of cancer-related death worldwide. Patients with more advanced disease have very few treatment options. OMP-54F28 holds the potential to make a real difference for these patients as it was designed to attack so-called cancer stem cells that can generate new cancer cells and are particularly resistant to currently available cancer drugs."

Five additional investigators and clinical sites are participating in this trial: Celina Ang, M.D., Mount Sinai Hospital, New York, NY; Crystal Denlinger, M.D., Fox Chase Cancer Center, Philadelphia, PA; Anthony El-Khoueiry, M.D., University of Southern California, Los Angeles, CA; Thomas Purcell, M.D., M.B.A., University of Colorado, Aurora, CO, and Andrew Zhu, M.D., Ph.D., Dana-Farber/Harvard Cancer Center, Boston, MA.

"Preclinical data suggest that OMP-54F28 adds significant anti-tumor activity to sorafenib by eradicating tumor-initiating cells in models for hepatocellular cancer. The safety profile for OMP-54F28 in the single-agent Phase 1 study is favorable, and we will now explore its ability to combine with sorafenib in preparation for future potential randomized studies," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed.

Interim results for the single-agent, first-in-human Phase 1a trial for OMP-54F28 in solid tumor patients were recently presented at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. Results from the Phase 1a study showed that OMP-54F28 is well tolerated and modulates the Wnt pathway starting at low doses, as evidenced by pharmacodynamic biomarker analysis of hair follicles.

"One of our goals for 2014 is to have all six of the planned Phase 1b combination clinical studies up and running for our anti-cancer stem cell candidates targeting the Wnt pathway. With two of three Phase 1b combination clinical studies now underway for OMP-54F28, and the initiation of all three planned Phase 1b studies for vantictumab late last year, we are very close to achieving that objective," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "Data generated from these studies will provide the basis for Bayer to exercise their option to license OMP-54F28 and vantictumab and the trials will also serve to inform future Phase 2 clinical studies of these novel drug candidates."


Also Tuesday:


Advaxis, Inc. (Nasdaq:ADXS)
, a biotechnology company developing the next generation of cancer immunotherapies, announced that it will participate in the Canaccord Genuity Orphan Drug One-on-One Day, Monday, February 24, 2014 at the Omni Berkshire Place in New York.

AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG)
today announced the publication of data from a multi-institutional trial of MuGard in the online edition of the journal Cancer available at http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.

Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that it has entered into definitive agreements with certain existing shareholders whom are accredited investors and participated in the previously announced $3M convertible note and warrant financing.

athenahealth, Inc.(Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced that athenahealth senior management will present a corporate overview and an update on the company's service offerings at two upcoming investor conferences.

Biogen Idec (NASDAQ: BIIB)
announced today that Chairman of the Board William D. (Bill) Young will retire from the Company’s Board of Directors, effective at the Company’s 2014 annual meeting of stockholders.

Cancer Genetics (Nasdaq:CGIX)
, an emerging leader in DNA-based diagnostics, announced today the addition of Paul Rothman, MD, Dean of the Medical Faculty and CEO of Johns Hopkins Medicine, to the Company's Board of Directors.

Celsius Holdings, Inc., (Other OTC:CELH)
the creator and marketer of Celsius®, the world's first and only Negative Calorie beverage backed by clinical science, is excited to announce the partnership with NASCAR driver Blake Koch for the 2014 Nationwide Series.

Cerner (Nasdaq: CERN) announced today that it will make its 2014 Investment Community Meeting available through a webcast February 25 from 9:30 a.m. to 11:30 a.m. EST.

Dehaier Medical Systems Ltd. (Nasdaq:DHRM)
, an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that it received the exclusive distribution right renewal from Timesco in related to CLX laryngoscope products. Pursuant to the renewal agreement, Dehaier will continue to have the exclusive right to direct sale, distribute and bid of optima range products, including CLX and Eclipse blades and handles in mainland China through 2014.

Elite Pharmaceuticals, Inc. (OTCBB:ELTP)
announced today successful results from a pilot bioequivalence study initiated in December 2013 for ELI-201, a twice-daily opioid abuse deterrent oxycodone product with abuse deterrent technology.

Flexion Therapeutics, Inc. (Nasdaq:FLXN)
announced today the closing of its initial public offering of 5,750,000 shares of its common stock at an initial public offering price of $13.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 750,000 additional shares of common stock.

Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I)
, a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the year ended November 30, 2013.

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT)
, a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver and intestinal diseases, today announced the appointment of Sanj K. Patel and Glenn Sblendorio to the Company's Board of Directors, effective immediately.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX),
a biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease, today announced the appointment of Abraham Ceesay as Vice President of Marketing and Operations.

MannKind Corporation (Nasdaq:MNKD)
today reported financial results for the fourth quarter and full year ended December 31, 2013.

Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a provider of bio-based pest management and plant health products for the agricultural and water treatment markets, announced today that the company will host a conference call and webcast on Thursday, March 6, 2014, at 4:30pm Eastern Time to discuss its quarterly financial results for the period ended December 31, 2013.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate in RBC Capital Markets' Global Healthcare Conference being held February 25-26 in New York City.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
today announced that the manuscript "MM-141, an IGF-1R- and ErbB3-Directed Bispecific Antibody, Overcomes Network Adaptations That Limit Activity of IGF-1R Inhibitors" has been published in Molecular Cancer Therapeutics and selected for the Highlights section in the current issue (Volume 13, Issue 2).

M Line Holdings, Inc. (OTCQB:MLHC),
a leading provider of products, assemblies and services to the precision high tech segment of both the aerospace and medical industries as well as a seller of high end pre-owned Japanese Computer Numerically Controlled Equipment, today announced that it has added four new and two old reactivated significant customers.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced it has published data in the Journal of Urology demonstrating that its Prolaris test accurately predicted, based on biopsy specimens, which men would develop biochemical recurrence (BCR) or metastatic disease following radical prostate surgery.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
announces the appointment of John Moretz as special advisor to its Board of Directors.

Prothena Corporation plc (Nasdaq:PRTA)
, a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, announced today that it will report its fourth quarter and full year 2013 financial results on Thursday, March 6, 2014, after the close of the U.S. financial markets. 

RadNet, Inc. (Nasdaq:RDNT)
, a national leader in providing high-quality, cost-effective diagnostic imaging services through a network of owned and operated outpatient imaging centers, announced today that it will host a conference call to discuss its fourth quarter 2013 financial results on Monday, March 3rd, 2014 at 7:30 a.m. Pacific Time (10:30 a.m. Eastern Time).

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP)
announced today the acquisition of six senior housing campuses with a total of 673 beds/units, covering the spectrum of care (292 skilled nursing beds, 213 independent living units and 168 assisted living units).

Swisher Hygiene Inc. (Nasdaq:SWSH) (TSX:SWI)
, a leading provider of essential hygiene and sanitizing products and services, today announced that it will be presenting at the Robert W. Baird 2014 Business Solutions Conference on Tuesday, February 25, 2014 at The Pierre in New York City.

Symmetry Medical Inc. (NYSE:SMA)
, a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that Thomas Sullivan, President and Chief Executive Officer, and Fred Hite, Senior Vice President and Chief Financial Officer, are scheduled to present at three upcoming investor conferences.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
today announced it has signed a non-binding term sheet to purchase the assets of the OcuHub business unit from AOAExcel, Inc., the for-profit subsidiary of the American Optometric Association.

Vitacost.com, Inc. (Nasdaq:VITC)
, a leading online retailer of healthy living products, will release results for the fourth quarter and full year ended December 31, 2013 on Thursday, February 27, 2014 before market open.




"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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