|Provectus Poster on PV-10 Clinical Data from Phase 1 Study for Cancers of the Liver Presentation; FDA Grants Orphan Drug Designation To GlycoMimetics' GMI-1271|
|By Josh Gee|
|Thursday, 14 May 2015 18:28|
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 13, 2015.
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT), a clinical-stage oncology and dermatology biopharmaceutical company, announced the abstract titled, "Phase 1 Study of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer Metastatic to the Liver," to be presented at the European Society for Medical Oncology’s 17th World Congress on Gastrointestinal Cancer, is scheduled for Thursday, July 2, 2015 from 10:30 to 11:00 a.m. and 4:55 to 5:25 p.m. local time. Sanjiv S. Agarwala, MD, of St. Luke's University Hospital and Health Network, Bethlehem, PA, will be the presenter.
Dr. Craig Dees, PhD, CEO of Provectus, said, "We are very pleased that Dr. Agarwala will be presenting this important information to the World Congress on Gastrointestinal Cancer. While our research into PV-10 as a treatment for melanoma continues, we are equally committed to determining its safety and efficacy in the treatment of other types of cancer. We are optimistic that PV-10 will prove to be a useful weapon against a wide variety of cancers.”
The ESMO 17th World Congress on Gastrointestinal Cancer will run from July 1 – 4, 2015 in Barcelona, Spain.
PV-10, a 10% solution of Rose Bengal that is currently being investigated as a potential cancer therapeutic, is designed for injection into solid tumors (intralesional administration).
About the European Society for Medical Oncology -- The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology and promoting a multidisciplinary approach to cancer treatment and care.
ESMO's mission is to advance cancer care and cure through fostering and disseminating good science that leads to better medicine and determines best practice. ESMO's scientific journal, Annals of Oncology, ranks among the top clinical oncology journals worldwide. ESMO events are the meeting place in Europe for medical oncologists to update their knowledge, to network and to exchange ideas.
To find out more about ESMO, please visit: www.esmo.org.
GlycoMimetics, Inc. (NASDAQ: GLYC) announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to GMI-1271, a novel and proprietary E-selectin antagonist in the company's pipeline for treatment of patients with acute myeloid leukemia (AML). GlycoMimetics is currently recruiting patients in a Phase 1/2, open-label multicenter study designed to evaluate the safety, pharmacokinetics and efficacy of GMI-1271 in combination with chemotherapy in adult patients with AML; a Phase 1 study in healthy volunteers was completed last year.
"Having the FDA designate GMI-1271 as an orphan drug for the treatment of AML is an important accomplishment for GlycoMimetics. This is a significant regulatory milestone for our program," said Helen Thackray, M.D., FAAP, Vice President of Clinical Development and Chief Medical Officer, GlycoMimetics. "We look forward to advancing GMI-1271 through clinical trials targeting E-selectin for multiple blood, or hematologic, cancers."
The FDA's Orphan Drug designation program is designed to promote the development of promising therapeutics for the treatment of rare diseases affecting fewer than 200,000 people in the United States. Orphan Drug designation includes benefits such as a potential seven-year period of U.S. marketing exclusivity after approval. Other potential advantages include protocol assistance, the ability to apply for research funding, tax credits for certain research expenses, and regulatory fee waivers.
3D Systems (NYSE:DDD) announced today the release of a virtual reality robotic prostatectomy training module and 3D printed soft tissue models that will assist urologists in the training and planning of robotic procedures. 3DS' anatomical 3D printed models and the RobotiX Mentor's new Prostatectomy Module will be showcased at the Annual Meeting for the American Urological Association (AUA), May 15 - 19, 2015 in New Orleans in booth #953.
Alliqua BioMedical, Inc. (Nasdaq:ALQA), a provider of advanced wound care products, today announced financial results for the first quarter ended March 31, 2015.
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, today announced that it has entered into a manufacturing agreement with Catalent Pharma Solutions (NYSE:CTLT), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, for clinical-grade production of MANF (mesencephalic-astrocyte-derived neurotrophic factor).
Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis® technology platform, today reported financial results for the first quarter ended March 31, 2015 and provided an update on the Company's clinical programs.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for the treatment of cancer and other life threatening diseases, today announced data supporting the development of AR-12 as a broad-spectrum, host-directed antiviral drug.
Avalanche Biotechnologies, Inc. (Nasdaq:AAVL), a clinical-stage biopharmaceutical company committed to improving or preserving the sight of people suffering from blinding eye diseases with an unmet medical need, announced that three posters, including one providing baseline demographics and characteristics from its Phase 2a clinical trial for AVA-101, will be presented at the American Society of Gene & Cell Therapy (ASGCT) 18th Annual Meeting in New Orleans.
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company with industry-leading expertise in the development of cardiovascular gene therapy, today announced financial results for the quarter ended March 31, 2015 and recent corporate updates.
ChromaDex Corp. (OTCQX:CDXC), an innovative natural products company that provides proprietary, ingredients and science-based solutions to the dietary supplement, food and beverage, cosmetic and pharmaceutical industries, announced today record revenue for the first quarter ended April 4, 2015.
GeneNews Limited (TSX:GEN) today reported operational and financial results for the three-month period ended March 31, 2015.
INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to Phase IV contract research organization, today completed the previously announced secondary public offering of 8,050,000 shares of the Company's Class A common stock by its existing shareholders and the repurchase of 5,053,482 shares of its Class A common stock.
Industrial hemp biosciences industry leader, AXIM Biotechnologies, Inc. (OTC:AXIM), is proud to announce that the Company has successfully secured an exclusive license from CanChew® Biotechnologies, LLC (CanChew), to further develop and produce CanChew® gum, a unique, patented controlled-release cannabinoid-infused chewing gum.
Immunomedics, Inc., (Nasdaq:IMMU) today announced that two of its five abstracts submitted to the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) have been accepted as oral presentations.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has acquired Accountability Healthcare, a post-acute care practice group headquartered in Birmingham, Alabama.
The Joint Corp. (Nasdaq:JYNT), a national healthcare operator and franchisor of chiropractic clinics, today reported financial results for the first quarter ended March 31, 2015.
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that David Roberts, President, will present at the 2015 Marcum MicroCap Conference on Thursday, May 28, 2015 in New York City at the Grand Hyatt Hotel.
Medical Marijuana, Inc. (OTC Pink:MJNA), a leading cannabis and industrial hemp industry innovator, sources, evaluates and acquires value-added companies with a focus on the medicinal cannabis and industrial hemp industries.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies through its MolDx program, has issued a favorable draft local coverage determination (LCD) for the Prosigna Breast Cancer Assay.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cell (CSC) and immuno-oncology pathways, today announced that Paul J. Hastings, Chairman and Chief Executive Officer, will present a corporate overview at the UBS 2015 Global Healthcare Conference on Wednesday, May 20, 2015 at 8:30 a.m. ET in New York
Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the first quarter ended March 31, 2015.
Pazoo, Inc. (Pink Sheets:PZOO) (German WKN#:A1J3DK) is pleased to present to the investment community an update on where Pazoo stands today.
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize energy to treat cancer, today announced year-to-date operational highlights and financial results for the first quarter ended March 31, 20151.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that management will be presenting at the UBS Global Healthcare Conference at the Sheraton New York Times Square Hotel in New York City.
StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing novel cell-based therapeutics for treating diseases of the central nervous system, announced today that Dr. Armin Curt, principal investigator, will present a summary of the safety and preliminary efficacy data from the Phase I/II study investigating Human Central Nervous System Stem Cell (HuCNS-SC) intramedullary transplantation in thoracic spinal cord injury. The summary will be presented today at 10:15 a.m. EDT at the 4th Joint International Spinal Cord Society (ISCoS) and American Spinal Injury Association (ASIA) meeting being held in Montreal, Canada.
Stemline Therapeutics, Inc. (Nasdaq:STML), announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the UBS Global Healthcare Conference on Monday, May 18, 2015 at 2:30 PM ET.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced the results of its Annual Stockholder Meeting, which was held today at 8:30 AM Eastern Time in Waltham, Massachusetts. Garry A. Nicholson has been elected to the TESARO Board of Directors.
TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, age-related macular degeneration and fibrotic diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of TRC105 in patients with advanced renal cell carcinoma (RCC) that have progressed following treatment with one inhibitor of the VEGF pathway in combination with standard dose Inlyta® (axitinib).
Vericel Corporation (Nasdaq:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today reported financial results for the quarter ended March 31, 2015.