Gentiva leads healthcare climbers; Given Imaging Initiates Pivotal Trial in Japan Print E-mail
By Staff and Wire Reports   
Tuesday, 15 November 2011 20:14
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 15, 2011.


Gentiva Health Services (NASDAQ:GTIV) led healthcare stock and closed at 5.97+0.79 (15.25%) following rumors that the firm may successfully secure an amendment related to an expect covenant breach in the fourth quarter. The chatter was first discussed in a Raymond James research note from Tuesday morning.

Gentiva is a provider of comprehensive home health and related services. The company serves patients through more than 500 direct service delivery units and through CareCentrix®, which manages home healthcare services for major managed care organizations throughout the United States. It was incorporated in 1999.

Given Imaging (NASDAQ:GIVN)
, a world leader in GI medical devices and pioneer of capsule endoscopy, announced the initiation of a pivotal PillCam® COLON 2 study in Japan intended to support the Company's planned regulatory submission to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

The study will compare patients with polyps which have previously been identified by optical colonoscopy with the PillCam COLON 2 capsule endoscopy procedure. The primary endpoint of the study is identifying polyps greater than or equal to six millimeters (6 mm) in size. Three sites will enroll a total of 72 patients, aged 40-75 years. Results will be read by two groups of readers; one at the investigator sites and the other at a central reading facility. The Company anticipates that the enrollment phase of the trial will be completed by the end of March 2012, with submission to PMDA in the middle of next year.

PillCam COLON 2 video capsules feature bi-directional communications between the PillCam COLON 2 capsule and the DataRecorder 3, and an Adaptive Frame Rate (AFR), which adjusts the image capture rate from 4 frames per second (fps) to 35 fps, based on capsule movement. The system also includes RAPID® v7 software, featuring unique tools to increase physician reading efficiency and aid in image interpretation.

PillCam COLON 2 received the CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, Australia and parts of Asia. An 800-Patient Multi-Center, Pivotal Trial for PillCam® COLON 2 is currently underway in the U.S. More than 2,000 patients have undergone PillCam COLON capsule endoscopy.

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Apricus Biosciences, Inc. (Nasdaq: APRI)
announced its NexACT® out-licensing partner, Exodos Life Science Limited Partnership, a privately-held company located in Chapel Hill, North Carolina, has completed a successful pre-IND meeting with the U.S. Food and Drug Administration regarding its plan to conduct clinical trials to establish the safety and effectiveness of its patented, topical painkilling drug, ELS115, containing NexACT® technology licensed from Apricus Bio.

Specifically, the meeting was a successful milestone in Exodos' effort to file an IND with the FDA for a topical, non-steroidal, anti-inflammatory drug, combining the existing drug, ketoprofen, with Apricus Bio's NexACT® technology. The NexACT® technology is designed to permit drugs to be delivered through the skin with enhanced absorption and bioavailability.



Also Tuesday:



ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, has announced its third quarter 2011 investor conference call and the recent progress in its MuGard program.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced today that it will present new data from its ALN-TTR program at the VIIIth International Symposium on Familial Amyloidotic Polyneuropathy being held in Kumamoto, Japan from November 20-22, 2011.

AstraZeneca (NYSE: AZN) today announced full results from the SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN) study, which demonstrated that aggressive treatment with a statin can lower LDL-C (“bad” cholesterol) to an average of 70 mg/dL or less, increase HDL-C (“good” cholesterol) to an average of approximately 50 mg/dL, and reduce plaque in the arteries of the heart.

BioDrain Medical, Inc. (OTCBB: BIOR) (OTCQB: BIOR), producer of the FDA-cleared STREAMWAY System for automated surgical fluid disposal, announced today that the Company has shipped its patented STREAMWAY Systems to fulfill a recent multi-unit purchase order totaling approximately $90,000 from an East Coast-based hospital.

Bio-Reference Laboratories, Inc. (NASDAQ: BRLI) announced today that it has been named the 8th Fastest Growing Company in New Jersey according to NJBiz at the 2011 50 Fastest Growing Companies of NJ award ceremony held in Somerset, NJ last night.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Adolor Corporation (NASDAQ: ADLR) today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with Cubist’s previously announced acquisition of Adolor.

CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to treat life-threatening illnesses, announced its financial results for the third quarter of fiscal 2011.

FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning™, reported today its first quarter of fiscal 2012.

InspireMD, Inc. (OTC BB: NSPR) ("Inspire" or the "Company"), a medical device company focusing on the development and commercialization of its proprietary stent platform technology, today announced that it has filed its Form 10-Q for the three months ended September 30, 2011 with the U.S. Securities and Exchange Commission.

International Stem Cell Corporation (OTCBB:ISCO)
today announced financial results for the three-month and nine-month periods ended September 30, 2011. ISCO is a development-stage biotechnology company that created, patented and is commercializing a powerful new stem cell technology called parthenogenesis which promises to advance significantly the field of regenerative medicine.

Masimo (NASDAQ: MASI) today announced that its management is scheduled to present at the 23rd Annual Piper Jaffray Health Care Conference at The New York Palace in New York on Tuesday, November 29, 2011 at 9:30 a.m. Eastern Time.

MedeFile International, Inc. (OTCQB: MDFI) (PINKSHEETS: MDFI), a leader in Internet-enabled Personal Health Record (iPHR) management solutions, today announced its financial and operational results for the three and nine months, ended September 30, 2011.

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that positive data from a Phase I/II clinical trial of EPODURE to treat anemia in chronic kidney disease patients was highlighted in a poster presentation at the American Society of Nephrology’s Kidney Week 2011, held November 8-13 in Philadelphia.

Mediware Information Systems, Inc. (NASDAQ: MEDW) announced that Michael Martens will step down as chief financial officer of the company effective February 15, 2012. Mr. Martens leaves the Company to rejoin a former employer.

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (“Oncolytics”) today announced that interim results from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

 


Palatin Technologies, Inc. (NYSE Amex: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced results for its first quarter ended September 30, 2011.

PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that it has been selected as one of two strategic partners by UCB, a global biopharmaceutical company, to provide clinical development services worldwide.

Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that its Focus Diagnostics business has CE marked its new Simplexa Cytomegalovirus (CMV) molecular test kit on the 3M™ Integrated Cycler for distribution to approximately 35 countries in Europe.

Remedent, Inc. (OTCBB: REMI), an international company specializing in research, development, and the manufacturing of oral care and cosmetic products, announced today that it filed a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission with regard to its form 10-Q report for the quarter ended September 30, 2011.

Rotoblock, Inc. (OTCBB: RTBC), a Nevada corporation (the "Company"), amended its previous Share Exchange Agreement for the acquisition of daifuWaste Management Holding.

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that it has signed a Stock Purchase Agreement with the Prentke Romich Company of Wooster, Ohio (PRC) to sell Simulations Plus’ wholly owned Words+ subsidiary to PRC for $2.1 million subject to ordinary adjustments for changes in net working capital.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that preclinical results presented at the AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference show that ganetespib, a potent Hsp90 inhibitor, is highly effective in overcoming mechanisms of resistance in models of multiple oncogene addicted tumors.

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
today announced that it has secured a freeze from certain debt holders to refrain from converting debt to equity through January 15th, 2012.

University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS), a diversified, integrated multi-specialty health delivery system, today announced improved financial results for the third quarter of 2011, during which total revenue increased 40% to $21.0 million, net patient revenue rose 26% to $19.0 million, operating income improved 117% to $2.5 million and EBITDA totaled $4.6 million, an improvement of 58%.

XenoPort, Inc. (Nasdaq: XNPT) announced today that it will provide access via the World Wide Web to its presentation at the 23rd Annual Piper Jaffray Health Care Conference.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company employing small molecule and synthetic biology approaches to cancer therapy, announced today new preclinical data from two separate studies of darinaparsin (Zinapar® or ZIO-101), a novel organic arsenic, in various solid tumor models at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place November 12-16 in San Francisco.




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