Progenics Relaunches Registrational Trial of Azedra; Repros Granted Face to Face Meeting With FDA on Androxal Efficacy Print E-mail
By Staff and Wire Reports   
Monday, 25 November 2013 20:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 25, 2013.

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) announced it is resuming a phase 2b clinical study of safety and efficacy of a novel targeted radiotherapy, Azedra™, in patients suffering from pheochromocytomas. Existing options for these rare endocrine tumors that form in the adrenal glands can fail to result in effective disease treatment.

Daniel Pryma, M.D., Assistant Professor of Radiology and Nuclear Medicine/Molecular Imaging Modality Chief of the Department of Radiology at the University of Pennsylvania Perelman School of Medicine, and lead investigator in the trial, said, "I have seen in my own research evidence that Azedra is a promising agent for the treatment of metastatic pheochromocytoma and paraganglioma – two orphan oncology indications with tragically unmet needs. There currently are no medications approved specifically to treat pheochromocytomas and paragangliomas."

Azedra originally was developed by Progenics' Molecular Insight Pharmaceuticals (MIP) subsidiary, which commenced the phase 2b study under a 2009 Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA). The compound also has Orphan Drug and Fast Track designations, which are intended to get important new therapies to patients sooner by expediting the review of drugs for serious conditions filling unmet medical needs. In late 2010 MIP suspended the trial, with enrollment two-thirds complete, to seek additional funding. Progenics, which acquired MIP in early 2013, plans for patient recruitment to continue after making drug supply manufacturing arrangements for the trial.

Following a successful completion of this phase 2b study, Progenics intends to submit a New Drug Application (NDA) and request priority review to receive FDA action on the application within six months instead of the standard ten.

Hagop Youssoufian, M.Sc., M.D., Executive Vice President of Research and Development for Progenics, said, "Azedra has the potential to be the first approved treatment for pheochromocytomas. Our team is energized by this opportunity to potentially bring a treatment option with improved dosing, safety and efficacy to patients suffering with these devastating conditions."



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Repros Therapeutics Inc.® (Nasdaq: RPRX)
reported it has been granted a face to face meeting with the FDA to discuss the pivotal Androxal efficacy studies per the announcement of October 22, 2013. Prior to the meeting, the Agency will have had the final clinical study reports made available.

The meeting will also address the unmet medical need for therapy producing restoration of total testicular function, i.e. restoration of T levels without the characteristic suppression of spermatogenesis by marketed testosterone replacement products. To enhance this discussion, the Company has proposed attendance of two of its key opinion leaders, Wayne Hellstrom, M.D., F.A.C.S., Professor of Urology and Chief of Andrology, Tulane University and incoming President of ISSM and Edward Kim, Ph.D., Professor at University of Tennessee Graduate School of Medicine.

The Company will report the outcome of the meeting before the end of February 2014.




Also Monday:





Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, today announced it will present at the 2013 Oppenheimer Healthcare Conference on Wednesday, December 11, 2013 at 8:55 AM Eastern Time at the Crowne Plaza Times Square, New York.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, today announced that the Italian Medicines Agency (AIFA) has granted national phase approval to Vitaros®, indicated for the treatment of patients with erectile dysfunction ("ED").

Athersys, Inc. (Nasdaq:ATHX)
announced today that the Company will present at the 25th Annual Piper Jaffray Healthcare Conference taking place at The New York Palace on December 3rd and 4th, 2013 in New York City.

Bioheart, Inc. (OTCQB: BHRT)
, a biotech company focused on the discovery, development and commercialization of autologous cell therapies, has announced that it has initiated a new clinical site in collaboration with Global Stem Cell Group in Cozumel, Mexico.

Caliber Imaging & Diagnostics (OTCQB:LCDX)
, formerly Lucid, Inc., has appointed Robert P. Fischmann to the role of Vice President of Operations, a newly created position.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based diagnostics, is presenting data from its research collaboration with Memorial Sloan-Kettering Cancer Center ("MSKCC") at the American Society of Hematology ("ASH") 55th Annual Meeting and Exposition.

CAS Medical Systems, Inc. (Nasdaq:CASM)
, a leader in medical devices for non-invasive patient monitoring, today announced that its FORE-SIGHT Cerebral Oximeter has been approved by the China Food and Drug Administration (CFDA) for sale in that country.

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 independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 SEAMLESS study in acute myeloid leukemia (AML) has completed its third planned safety review and recommended that the study should continue as planned without any modifications.

Endologix, Inc. (Nasdaq:ELGX),
developer and marketer of innovative treatments for aortic disorders, announced today that Shelley Thunen, Chief Financial Officer, is scheduled to present at two investor conferences in December.

Graymark Healthcare Inc. (OTCQB: GRMH)
, which focuses on the development and management of surgical hospitals and ancillary service lines through its recent acquisition of Foundation Healthcare, announced that Stanton Nelson, CEO and president, will present at the LD Micro Conference held December 3-5, 2013 at the Luxe Sunset Boulevard Hotel in Los Angeles, CA. Graymark will present on December 4th at 7:30 AM, Pacific Time, track 4.

HPIL Holding (OTCQB: HPIL)
is pleased to announce that, through its wholly owned subsidiary HPIL ART&CULTURE, INC., is officially sponsoring and participating at the W.T.F.S.K.F. - 5th World Traditional Fudokan Shotokan Karate-Do Championship.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA),
a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that its presentation at the 2013 Deutsche Bank BioFEST Conference will be webcast on Monday, December 2 at 4:35 p.m. ET.

Nuvilex, Inc. (OTCQB:NVLX)
, a biotech company developing therapies for cancer, diabetes and other diseases based upon its live-cell encapsulation platform, today announced that Kenneth L. Waggoner, Esq. has been appointed Chief Executive Officer and President and that Dr. Robert F. Ryan, M.S., Ph.D., has been appointed Chief Science Officer.

OraSure Technologies, Inc. (Nasdaq:OSUR)
announced today that it is reaffirming its fourth quarter 2013 financial guidance, which the Company last updated in a press release it issued on November 21, 2013.

Portola Pharmaceuticals, Inc. (Nasdaq:PTLA)
today announced that it has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for andexanet alfa, its investigational Factor Xa inhibitor antidote.

Premier, Inc. (Nasdaq:PINC)
, a leading healthcare improvement company, today announced that it will participate in the 25th Annual Piper Jaffray Healthcare Conference on December 3, 2013, at the New York Palace Hotel in New York.

Prosensa Holding N.V. (NASDAQ: RNA)
the Dutch biopharmaceutical company focusing on rare diseases with a high unmet medical need, and Newcastle University, UK, have announced the award of a second Framework Programme 7 (FP7) research grant from the European Commission.

Rand Capital Corporation (NASDAQ: RAND)
a Buffalo, New York based Small Business Investment Company (SBIC) notes that Towers Watson (NYSE: TW) (NASDAQ: TW) a global professional services company, announced that it has acquired Rand portfolio company, Liazon Corporation (Buffalo, NY), a provider of private exchange solutions and online benefit marketplace's for a purchase price of $215 million.

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 the first patient has been recruited and dosed in the MAP US study - a Phase III clinical study designed to evaluate the safety and efficacy of fixed-dose RHB-104 in patients with moderately to severely active Crohn's disease.

Repros Therapeutics Inc.® (Nasdaq:RPRX)
today reported it has been granted a face to face meeting with the FDA to discuss the pivotal Androxal efficacy studies per the announcement of October 22, 2013.

Repros Therapeutics Inc.® (Nasdaq:RPRX)
today reported it will deliver an invited podium presentation at the 9th Men's Health World Congress entitled "Oral Enclomid (Androxal) Raises Total Serum Testosterone in Men with Secondary Hypogonadism: Comparison with a Topical Gel".

Response Biomedical Corp. (TSX:RBM)(OTCBB:RPBIF)
today announced that it has entered into agreements to distribute its Cardiovascular portfolio of RAMP® products with two new distributors in China, doubling Response's total number of distributors in a country that represents more than 60% of Response's worldwide sales.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
announced today that Edward Lanphier, Sangamo's president and CEO, will provide an update on the progress of Sangamo's ZFP Therapeutic® development programs and an overview of the company's business strategy at 8:00 am ET on Wednesday, December 4, 2013, at the 25th Annual Piper Jaffray Healthcare Conference, which will be held in New York City.

SK3 Group, Inc's (OTC Pink: SKTO)
subsidiary Medical Greens is pleased to announce that its managed wholesale collectives portfolio has reached a new distribution agreement for the sale of the Company's products in over 400 collectives throughout California, including: Dharmanol, Canna-Loz Organic Oil, T-Hydro-Can, Yak Capsules, Yeti Honeybud Oilers, Organakoil, Red Diamond Oil, Greenie Whole Plant Cookies, Haute Chocolate Instant Drink Mix, and Mocha-juana Instant Drink Mix.

SpectraScience, Inc. (OTCQB:SCIE)
, a medical device company utilizing light technologies to detect and diagnose cancers, announced today that Michael P. Oliver, President and CEO, will present at the 6th Annual LD Micro Conference in Los Angeles from December 3rd through 5th, 2013.

Tauriga Sciences Inc. (OTCQB:TAUG)
, a diversified company focused on generating profitable revenues through license agreements and the development of a proprietary technology platform in the nanorobotics space, has today announced the execution of a definitive agreement to acquire Cincinnati, Ohio based Pilus Energy LLC, a developer of alternative cleantech energy platforms using proprietary microbial solutions that creates electricity while consuming polluting molecules from wastewater.

TESARO, Inc. (Nasdaq:TSRO)
announced today that Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President of TESARO, will present at the 2013 Deutsche Bank BioFEST conference at the Four Seasons Hotel in Boston on Monday, December 2, 2013 at 2:15 p.m. Eastern time.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative, clinical-stage biopharmaceutical company today announced that it has initiated a multi-center, Phase I trial to evaluate the safety and efficacy of the combination of TG-1101 (ublituximab) and TGR-1202 for patients with relapsed and/or refractory Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL).

United-Guardian, Inc. (Nasdaq:UG) announced today that on November 22nd its Board of Directors declared a $0.50 per share cash dividend, payable on December 20, 2013 to all stockholders of record on December 6, 2013.

Ventrus Biosciences, Inc. (Nasdaq:VTUS) announced that it has completed patient enrollment and randomization in the second Phase 3 clinical trial of Diltiazem Hydrochloride 2% Cream (VEN 307) in patients with pain related to anal fissure (AF). Ventrus anticipates that data from this Phase 3 study will be available in the first quarter of 2014, and it expects to file a New Drug Application (NDA) for VEN 307 in the second quarter of 2014.



"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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