New Study of Pluristem's PLX Cells To Commence; Pluristem's Phase I/II Muscle Injury Trial Successful Print E-mail
By Staff and Wire Reports   
Monday, 03 February 2014 20:24
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 3, 2014.

Pluristem Therapeutics, Inc.  (NASDAQ:PSTI)
, a leading developer of placenta-based cell therapies, today announced that the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), will commence a mechanism-of-action study of Pluristem's PLacental eXpanded RAD (PLX-RAD) cells for the treatment of acute radiation syndrome (ARS). The study aims to investigate the effect of PLX-RAD cells on body weight, blood count parameters, cytokine concentrations and bone marrow or spleen cellularity at various time points following the administration of PLX-RAD cells to animals receiving total body irradiation. The study is scheduled to begin in February 2014.

Following positive data from NIAID's first study of PLX-RAD cells on irradiated animals' hematological systems, Pluristem had announced on July 18, 2013 NIAID's intention to expand the scope of its PLX-RAD research. NIAID's initial work showed that the overall survival of irradiated rodents treated with PLX-RAD cells significantly increased compared to that of the control group.

"In this study, NIAID will expand the focus of its work to better understand the mechanism-of- action of PLX-RAD cells. We are pleased that NIAID has recognized the therapeutic potential of these cells in treating ARS," stated Zami Aberman, Chairman and CEO of Pluristem.

Pluristem has a preclinical hematology program in which the company is evaluating PLX-RAD cells in the treatment of bone marrow failure following radio- or chemotherapy. Data from the NIAID studies are expected to be beneficial to our hematology program.

ARS studies of PLX-RAD cells also have been conducted by Prof. Raphael Gorodetsky, lead investigator of the study and head of the Biotechnology and Radiobiology Laboratory at the Sharett Institute of Oncology at the Hadassah Hebrew University Medical Center. Those studies showed an up to four-fold increase in the survival rate of irradiated animals treated with PLX cells versus those treated with placebo, as well as improvements in additional parameters. The preclinical results for PLX-RAD cells have been published in peer reviewed journal PLOS ONE.


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Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced top-line results from its Phase I/II clinical trial testing the safety and efficacy of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury. The trial indicated PLX-PAD cells were safe and statistical significance was reached (p=0.0067) for the primary efficacy endpoint of the study, the change in maximal voluntary isometric contraction force of the gluteal muscle at six months after total hip replacement. Patients treated with PLX-PAD had a greater improved change of maximal voluntary muscle contraction force than the placebo group. These results provide evidence that PLX cells may be efficacious in the treatment of orthopedic injuries including muscles and tendons.

This Phase I/II trial was a randomized, placebo-controlled, double-blinded study conducted at the Orthopedic Clinic of the Charité University Medical School under the auspices of the Paul-Ehrlich-Institute (PEI), Germany's health authority. The injured muscle studied was the gluteus medius muscle in the buttock. Total hip replacement surgery via the standard transgluteal approach necessitates injury of the gluteus medius muscle, and post-operative healing is crucial for joint stability and function.

The 20 patients in the study were randomized into three treatment groups. Each patient received an injection in the gluteal muscle that had been traumatized during surgery. One group was treated with 150 million PLX-PAD cells per dose (n=7), the second was administered 300 million PLX-PAD cells per dose (n=6), and the third received placebo (n=7).

The primary safety endpoint was clearly met, with no serious adverse events reported at either dose level. The study showed that PLX-PAD cells were safe and well tolerated.

The primary efficacy endpoint of the study was the change in maximal voluntary isometric contraction force of the gluteal muscle at six months post-surgery. Efficacy was shown in both PLX-PAD treated patient groups, with the group receiving the 150 million cell dose displaying a statistically significant 500% improvement over the placebo group in the change of the maximal contraction force of the gluteal muscle (p=0.0067). Patients treated at the 300 million cell dose showed a 300% improvement over the placebo (p=0.18).

An analysis of the macrostructure of the gluteal muscle using magnetic resonance imaging (MRI) indicated an increase in muscle volume in those patients treated with PLX-PAD cells versus the placebo group. This efficacy endpoint was demonstrated in both PLX-PAD treated patient groups, with the group receiving the 150 million cell dose displaying a statistically significant superiority over the placebo group. Patients treated at the 150 million cell dose showed an approximate 300% improvement over the placebo in the analysis of muscle volume (p=0.004). Patients treated at the 300 million cell dose showed an approximate 150% improvement over the placebo in the change of muscle volume (p=0.19). The complete dataset that includes biopsy results and functional assessments will be presented at a medical conference once the final analyses are completed.

The study's Senior Scientist, Dr. Tobias Winkler of the Center for Musculoskeletal Surgery, Julius Wolff Institute Berlin, Charité -- Universitaetsmedizin Berlin, Germany, commented, "I am very impressed with the magnitude of the efficacy results seen in this trial. PLX cells demonstrated safety and suggested that the increase in muscle volume could be a mechanism for the improvement of contraction force."

Zami Aberman Chairman and CEO stated, "This was a very important study not only for Pluristem but for the cell therapy industry in general. The study confirms our pre-clinical findings that PLX-PAD cell therapy can be effective in treating muscle injury. Having a statistically significant result for our primary efficacy endpoint is very encouraging and consistent with our understanding of the mechanism of action associated with cell therapy. Based on these results, we intend to move forward with implementing our strategy towards using PLX cells in orthopedic indications and muscle trauma."


Also Monday:


Advaxis, Inc. (Nasdaq:ADXS)
, a biotechnology company developing the next generation of cancer immunotherapies, announced that Daniel J. O'Connor, Chief Executive Officer of Advaxis, will be presenting a company update at the 16th Annual BIO CEO & Investor Conference on Tuesday, February 11, 2014 at 3:30 p.m. ET.

Anavex Life Sciences Corp. (OTCQB:AVXL)
today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will be presenting at the 16th Annual BIO CEO & Investor Conference on Monday, February 10, 2014, at 1:00 p.m. ET in the Conrad Room.

Athersys, Inc. (Nasdaq:ATHX)
announced today that the Company will present at the 2014 BIO CEO & Investor Conference to be held at the Waldorf Astoria from February 10-11, 2014 in New York City.

BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, announced today a significant victory in the patent infringement case against Mednet Healthcare Technologies, Inc. and its subsidiaries, Heart-Care Corporation of America, Universal Medical Inc., and Universal Medical Laboratory, Inc. as well as other named defendants.

Celator Pharmaceuticals, Inc. (Nasdaq:CPXX)
, a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that Scott Jackson, Chief Executive Officer, will now present an overview of the company at the 16th Annual BIO CEO and Investor Conference on Monday, February 10, 2014, at 9:00 a.m. EST.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT)
, a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced its scheduled presentation to provide an overview of the company's programs and outlook at the Biotechnology Industry Organization (BIO) CEO & Investor Conference at 1:00 p.m. ET on Monday, February 10, 2014, in New York.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that the Company will present at the 16th Annual BIO CEO & Investor Conference, being held at the Waldorf Astoria Hotel in New York City, New York.

Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today that it was granted a patent by the Canadian Patent and Trademark Office for the use of INFAT® for the promotion of intestinal development and maturation, and further announced that it was granted a patent by the U.S. Patent and Trademark Office for the use of INFAT® in enhancing infant bone strength.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer of Five Prime, will present at the 16th Annual BIO CEO & Investor Conference on Monday, February 10, at 2 p.m. Eastern Time.

Health Enhancement Products, Inc. (OTCQB: HEPI)
, which investigates and licenses algae-derived, high-value bioactive molecules that benefit human and animal health, announces preliminary research results for efficacy in addressing canine joint health.

Horizon Technology Finance Corporation (NASDAQ: HRZN)
, a leading specialty finance company that provides secured loans to venture capital and private equity backed development-stage companies in the technology, life science, healthcare information and services, and clean-tech industries, today announced it led an $8 million venture loan for AccuVein, Inc. ("AccuVein"), a developer of vein illumination technology.

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced today that Joseph Loscalzo, M.D., Ph.D., has joined the company's Board of Directors. 

LHC Group Inc. (Nasdaq:LHCG)
, a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that it has signed a definitive stock purchase agreement with BioScip®, Inc. (Nasdaq:BIOS) to purchase two of its operating subsidiaries, doing business as Deaconess HomeCare and Elk Valley Health Services, for $60 million.

Lion Biotechnologies, Inc. (OTCQB:LBIO)
announced that Chairman and CEO, Manish Singh, Ph.D., has issued the following letter to the shareholders.

Luminex Corporation (NASDAQ: LMNX)
today announced financial results for the fourth quarter and year ended December 31, 2013. 

Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a leading global provider of bio-based pest management and plant health products, announced it has secured a license of certain intellectual property rights from Kao Corporation for a plant health active ingredient.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Merge Cardio™ has been named Best in KLAS for the cardiology software category within the "2013 Best in KLAS: Software & Services" report.

MMRGlobal, Inc. (OTCQB: MMRF)
, through its wholly owned subsidiary MyMedicalRecords, Inc., today announced that the California Superior Court ruled in favor of MMR and denied a demur brought by Surgery Center Management, LLC this morning.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that the Company and its subsidiary, Progenitor Cell Therapy, LLC, will present at multiple conferences in February.

NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY)
, a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today announced that Ron Najafi, Ph.D., Chairman and CEO, will present a corporate and clinical update at the BIO CEO & Investor Conference, held February 10-11, 2014 in New York City.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of deadly diseases, announced today that its subsidiary, Medical Marijuana Sciences, Inc., plans to use the unique and proprietary cellulose-based live-cell encapsulation technology known as Cell-in-a-Box™ to develop treatments for serious and deadly forms of cancer.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced the issuance of its fourth broad U.S. patent relating to antibodies that target the RSPO-LGR cancer stem cell pathway.

Catholic Health Partners (CHP), Ohio's largest health system, has received Premier, Inc.'s (Nasdaq:PINC) 2014 Richard A. Norling Premier Alliance Excellence Award for its leadership in accelerating innovation in care delivery.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that Kenneth I. Moch, President and CEO of Chimerix, will present at the 16th Annual BIO CEO & Investor Conference on Monday, February 10, 2014 at 4:30pm EST at the Waldorf Astoria in New York City.

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 and cell adhesion, announced today the closing of a previously announced underwritten public offering of its ordinary shares owned by Elan Science One Limited (the "Selling Shareholder"), an indirect wholly owned subsidiary of Perrigo Company plc ("Perrigo").

Portola Pharmaceuticals (Nasdaq:PTLA)
today announced that it has entered into a second clinical collaboration agreement with Bayer HealthCare and Janssen Pharmaceuticals, Inc. to evaluate its investigational Factor Xa inhibitor reversal agent, andexanet alfa*, in Phase 3 registration studies with the U.S. Food and Drug Administration (FDA)-approved oral Factor Xa inhibitor XARELTO® (rivaroxaban).

Relypsa, Inc. (Nasdaq:RLYP)
, a clinical-stage biopharmaceutical company, today announced that John Orwin, Chief Executive Officer, will speak at the 16th Annual BIO CEO and Investor Conference on February 10, 2014 at 9:30 am ET at the Waldorf Astoria in New York City, NY.

ScripsAmerica, Inc. (OTCBB:SCRC)
today announced that the Company has entered into a joint venture with Global Pharma Hub, an international pharmaceutical marketing and distribution company, to license, market and distribute its RapiMed® Children's pain reliever and fever reducer.

TearLab Corporation (Nasdaq:TEAR) (TSX:TLB)
today announced total revenue for the fourth quarter of 2013 is expected to be approximately $4.5 million, bringing expected full year 2013 revenues to approximately $14.7 million.

ThermoGenesis Corp. (Nasdaq:KOOL)
a cellular therapy medical device company and TotipotentRX Corporation, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular and orthopedic disease, announced the TotiPotentRX cellular therapy clinical team in partnership with Fortis Healthcare, Gurgaon (New Delhi) has achieved its 20th pediatric bone marrow transplant (BMT).

University General Health System, Inc. (OTCQB: UGHS)
a diversified, integrated multi-specialty health delivery system, today announced significantly improved revenue for the third quarter and first nine months of 2013.

Vision-Sciences, Inc. (Nasdaq:VSCI)
, a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced financial results for the third quarter and first nine months of fiscal year 2014, ended December 31, 2013.

ZELTIQ®, (Nasdaq:ZLTQ)
a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that Mark Foley, President and Chief Executive Officer, and Patrick F. Williams, Chief Financial Officer, are scheduled to present at the Leerink Global Healthcare Conference at the Waldorf Astoria in New York City.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced that Jonathan Lewis, M.D., Ph.D., Chief Executive Officer, and Francois Lebel, M.D., Senior Vice President, Clinical Development and Medical Operations, will present at the 16th Annual BIO CEO & Investor Conference on Monday, February 10th, 2014 at 10:00 a.m. ET at the Waldorf Astoria in New York City.



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