CytRx Wins FDA Acceptance for Protocol Trial; FDA Grants Priority Review to Lilly's Ramucirumab Print E-mail
By Staff and Wire Reports   
Wednesday, 23 October 2013 19:21
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 23, 2013.

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced additional preliminary data from its Phase 2b clinical trial demonstrating aldoxorubicin's potential advantage over doxorubicin in the treatment of soft tissue sarcoma (STS) will be presented at the 18^th Annual Connective Tissue Oncology Society (CTOS) Meeting on Thursday, October 31 at 4:30 p.m. Eastern time at the Sheraton New York Times Square Hotel.

The Company previously reported that patients in the trial treated with aldoxorubicin had an Overall Response Rate (ORR) of 22%, whereas those administered the widely used chemotherapeutic agent doxorubicin had an ORR of 0%. The Company expects to report top-line data for the global Phase 2b clinical trial in December 2013.

“Because CTOS draws thought leaders in the treatment of sarcoma from around the world, it provides an ideal forum to gain awareness of this compelling data and to acquaint the oncologists with our phase 3 study in patients with relapsed or refractory soft tissue sarcomas,” said CytRx President and CEO Steven A. Kriegsman. "Discoveries of new sarcoma treatments have been relatively few, particularly when compared with treatments for breast or prostate cancer, but the preliminary clinical results thus far drive our optimism that aldoxorubicin can fill an important medical need in patients with advanced soft tissue sarcoma. ”

STS is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. There are more than 30 types of STS, and according to the American Cancer Society more than 10,500 new cases are diagnosed each year in the U.S.

In addition to the Phase 2b trial for STS, the Company has received acceptance from the U.S. Food and Drug Administration (FDA) for a protocol to conduct a Phase 2 clinical trial with aldoxorubicin in glioblastoma, a difficult-to-treat and deadly brain cancer, and also plans to conduct a Phase 2 clinical trial in HIV-related Kaposi's sarcoma.


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Eli Lilly and Company (NYSE: LLY)
announced the U.S. FDA has assigned Priority Review to the regulatory submission for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.

"We are very pleased that the FDA has granted Priority Review to ramucirumab in advanced gastric cancer, as patients with this difficult-to-treat disease typically have a poor prognosis and limited treatment options," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "If approved, ramucirumab will be the first FDA-approved therapy for patients in this setting. Overall, stomach cancer is the second leading cause of cancer death globally and remains an area of high unmet need."

Priority Review status for a biologics license application, or BLA, means that the FDA's goal is to take action within eight months of a completed filing. Therefore, Lilly anticipates agency action on this application in the second quarter of 2014. The priority designation aims to expedite the review of applications for drugs that, if approved, would represent a significant advance in treatment.



Also Wednesday:



Abiomed Inc. (Nasdaq:ABMD)
, a leading provider of breakthrough heart support technologies, notes that there will be over 25 potential Impella presentations in the scientific sessions at the Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) 2013 scientific meeting, scheduled from October 27 – November 1, at the Moscone Convention Center in San Francisco, CA.

Air Methods Corporation (Nasdaq:AIRM)
, the global leader in air medical transportation, today announced that David Doerr joined the Company in the newly created position of Executive Vice President, Business Development.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced that Rush Health, a clinically integrated network of physicians and hospitals, has endorsed athenahealth's EHR and practice management services for its more than 300 affiliated private physician members.

Athersys, Inc. (Nasdaq:ATHX)
announced today that it has put in place a new equity facility with Aspire Capital Fund, LLC to replace the prior two-year agreement that has ended.

ATMI, Inc. (Nasdaq:ATMI),
a global technology company, today reported financial results for the third quarter of 2013.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL)
, a fully-integrated specialty biopharmaceutical company, today announced the first patient dosed in its Phase 2a study of collagenase clostridium histolyticum (or "CCH") for the treatment of edematous fibrosclerotic panniculopathy ("EFP"), commonly known as cellulite.  

BioMed Realty Trust, Inc. (NYSE:BMR)
today announced it will report results for its third quarter ended September 30, 2013 after the market closes on Tuesday, November 5, 2013.

The Boston Scientific Corporation (NYSE: BSX)
S-ICD® System has received the Prix Galien USA 2013 Award for Best Medical Technology.  The S-ICD System is the world's first and only commercially available subcutaneous implantable defibrillator (S-ICD) that treats patients at risk for sudden cardiac arrest (SCA) without wires touching the heart.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the completion of an underwritten public offering of 2,476,995 shares of its common stock at a price to the public of $16.50 per share. All of the shares were sold by certain existing stockholders.  

Cleveland BioLabs, Inc. (Nasdaq:CBLI)
today announced that Panacela Labs, Inc., a majority-owned subsidiary of CBLI, has entered into a contract valued at approximately 149 million rubles, or approximately $4.6 million, with the Ministry of Industry and Trade of the Russian Federation for development of Mobilan, a cancer vaccine in preclinical development.

CodeSmart Holdings, Inc. (OTCQB:ITEN)
, with its subsidiary, The CODESMARTTM Group, Inc. (collectively, "CODESMART"), a premier ICD-10 education and solutions group that offers CODESMARTTM UNIVERSITY, its on-line education solution and customizable training solutions, announced today that it has entered into a partnership agreement with Avisena, one of the nation's leading providers of revenue cycle management software and services for physician practices, to provide ICD-10 training and consulting services to their clients.

eHealth, Inc. (NASDAQ: EHTH)
, which operates eHealthInsurance.com, the nation's first and largest private online health insurance exchange, today announced that it is providing solutions for corporate retiree program beneficiaries, offering them access to a broad selection of Medicare and pre-Medicare health insurance choices.

Endocyte, Inc. (Nasdaq:ECYT)
, a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that the company will host a conference call on Tuesday, Nov. 5, at 4:30 p.m. EST to discuss its third quarter 2013 financial results and provide an operational update.

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 the appointment of Aron Knickerbocker, Senior Vice President and Chief Business Officer of Five Prime, to the company's Board of Directors and the appointment of Marc Belsky to the position of Chief Financial Officer.

GelStat Corporation (PINKSHEETS: GSAC)
, a consumer healthcare company primarily focused on the development and marketing of over-the-counter (OTC) products is pleased to announce that it has closed the acquisition of CBD Life Sciences, Inc.

Harvard Bioscience, Inc. (Nasdaq:HBIO) and Harvard Apparatus Regenerative Technology (Nasdaq:HARTV) jointly announce that five years after a 30-year-old woman was implanted with the world's first tissue-engineered trachea grown in a bioreactor she lives complication-free, according to an article published October 23 in The Lancet.

Hospira, Inc. (NYSE: HSP)
, the world's leading provider of injectable drugs and infusion technologies, today unveiled a new quality and analytical testing laboratory at its Rocky Mount, N.C., plant in a ribbon-cutting ceremony attended by North Carolina Governor Pat McCrory and other local and state government leaders.

Hospira, Inc. (NYSE: HSP)
, the world's leading provider of injectable drugs and infusion technologies, today announced the U.S. introduction of the Sapphire™ infusion system, representing a major step in the advancement of the company's global device strategy.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported that multiple cycles of therapy with the Company's pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 (90Y), in combination with low-dose gemcitabine, produced a median overall survival (OS) of more than 5 months in patients with metastatic pancreatic cancer who had received at least 2 prior treatments.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, today announced that the Company will report its financial results for the three and nine months ended September 30, 2013, before the opening of the stock market on Tuesday, November 5, 2013.

InspireMD, Inc. (NYSE MKT: NSPR)
, a leader in embolic protection stents, announced today that it will ring the Opening Bell at the New York Stock Exchange on Thursday, October 24, 2013 at 9:30 a.m. ET.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, announced plans to release its financial results for the third quarter of 2013 on November 7, 2013 after the close of the financial markets.

Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it plans to eliminate manufacturing operations in Burlington, Massachusetts.

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO)
today announced the election of Laurie Smaldone Alsup, M.D. to KaloBios' Board of Directors.

LHC Group Inc. (Nasdaq:LHCG)
, a national provider of post-acute care services, announced today details for the release of its results for the third quarter and nine months ended September 30, 2013.

Medical Marijuana, Inc. (OTC Pink:MJNA)
is pleased to inform shareholders and the general public that Cheryl Shuman, one of the most visible women in the medical cannabis reform movement and brand ambassador to HempMedsPX™—a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana, Inc.—defends medical cannabis and hemp-based cannabidiol (CBD) use on Dr. Phil this Friday, October 25th.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of clinical systems and innovations that seek to transform healthcare, announced today the scheduling of its third quarter 2013 earnings call, which will be held at 8:30 AM ET on Wednesday, October 30, 2013.

Merit Medical Systems, Inc. (Nasdaq:MMSI)
, a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced record revenues of $115.2 million for the quarter ended September 30, 2013, an increase of 20% over revenues of $95.9 million for the third quarter of 2012.

Mesoblast Limited (ASX:MSB)
, a world leader in the development of cell-based biologic products, Intrexon Corporation (NYSE:XON), a leader in synthetic biology, and ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the discovery and development of new cancer therapies, today announced a partnership to develop a new class of cancer therapeutics.

NeoGenomics, Inc. (NASDAQ: NEO)
, a leading provider of cancer-focused genetic testing services today reported its results for the third quarter of 2013.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ), a developer of real‐time medical imaging systems for use in the operating room, announced today that it has commenced an underwritten public offering of its common shares.

Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today financial results for the third quarter ended September 30, 2013.

Raptor Pharmaceutical Corp. (Nasdaq:RPTP)
and DaVita Clinical Research® (DCR®) (NYSE:DVA) today announced a collaboration to screen blood samples from patients with end-stage renal disease (ESRD) in an effort to identify patients with unrecognized late-onset nephropathic cystinosis.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today announced that Dror Ben-Asher, the Company's Chief Executive Officer, will present an overview of the Company at the 2013 Annual BioNetwork Conference, on Monday, October 28, 2013, at 12:15 p.m. EDT at the Ritz Carlton Hotel in Laguna Niguel, CA, U.S.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA)
today announced results of operations for the third quarter of 2013 and the impact of recently completed investments and updated its 2013 guidance.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
today reported third quarter 2013 financial results and accomplishments.

Sharps Compliance Corp. (Nasdaq:SMED)
, a leading full-service provider of solutions for the cost-effective management of medical waste, used healthcare materials and unused dispensed medications, announced today that Brandon Beaver has been appointed Senior Vice President of Sales to replace Berkley Nelson.

Sharps Compliance Corp. (Nasdaq:SMED)
, a leading full-service provider of solutions for the cost-effective management of medical waste, used healthcare materials and unused dispensed medications, today reported financial results for the first quarter fiscal year 2014 ended September 30, 2013.

Stereotaxis, Inc. (Nasdaq:STXS) today released certain preliminary financial results for the 2013 third quarter in anticipation of its previously announced rights offering of common stock, which is expected to commence in the near future.

Stereotaxis, Inc. (Nasdaq:STXS)
announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has classified its Niobe® Magnetic Navigation System as a C2 medical device.

Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
and its development and commercialization partner Takeda Pharmaceuticals U.S.A., Inc. (Takeda) today announced that Sucampo Pharma Americas, LLC (SPA) initiated a pivotal clinical trial of a liquid form of lubiprostone 24 mcg BID in adult subjects with chronic idiopathic constipation (CIC).

Techne Corporation (NASDAQ: TECH) today announced that management will host a conference call on Tuesday, October 29, 2013, at 7:30 a.m. CDT to review first quarter fiscal 2014 financial results.



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