News Column

Puma Bio More Than $100 After-Hours On Trial PB272; CEL-SCI Receives Regulatory Clearance To Expand Phase III Head And Neck Cancer Trial

July 30, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on July 22, 2014. {nfg}Puma Biotechnology (NYSE: PBYI) is trading more than 180 percent higher after-hours as news hit that the company released positive top line results from its Phase 3 PB272 trial in initial treatment for breast cancer.



The trial showed that with treatment, clients showed a 33 percent improvement in disease free survival versus placebo. According to the company website PB272 is:



"...a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors, or EGFRs, HER1, HER2 and HER4. We believe neratinib has clinical application in the treatment of several cancers, including breast cancer and gastric cancer. Our initial focus is on the development of neratinib as an oral treatment for patients with HER2-positive breast cancer."



A list of the 32 studies found for Puma Biotechnology at ClinicalTrials.gov







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CEL-SCI Corporation (NYSE MKT: CVM)
announced Turkey’s Ministry of Health has cleared the company to begin patient enrollment in CEL-SCI’s global pivotal Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). The Company expects to enroll patients through three clinical centers in Turkey. Turkey thus becomes the 16th country to participate in the world’s largest Phase III head and neck cancer trial.

“As we add more countries and subsequently more clinical centers, we see an acceleration of the pace of the Phase III trial. In the most recently reported three month period, we saw a 93% increase in patient enrollment over the prior three month period,” stated CEL-SCI Chief Executive Officer Geert Kersten. “We are pleased with the progress of our clinical program as we investigate the efficacy of Multikine immunotherapy to treat cancer.”



Head and neck cancer accounts for about 6% of all cancers, with approximately 600,000 new cases reported annually worldwide. CEL-SCI has received U.S. Orphan Drug designation for Multikine in head and neck cancer in the US.



Further expansion of the Phase III trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers by the end of 2015. Over 220 patients have been enrolled in the study to date.







Also Tuesday:





BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX)
today announced that its second quarter 2014 financial results will be released on Tuesday, August 5, 2014.



BioSpecifics Technologies Corp (Nasdaq:BSTC)
, a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications to date, will visit the NASDAQ MarketSite in Times Square.



BioTelemetry, Inc. (Nasdaq:BEAT)
will release its second quarter 2014 earnings on Thursday, July 31, 2014 at 4:00 PM Eastern Time.



Brewer Sports International (BSI), a multi-faceted global sports advisory firm, and Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to cell cycle dysregulation, endoplasmic reticulum stress, neurodegeneration and apoptosis, are proud to announce the Honorable Jim Greenwood, President & CEO of the Biotechnology Industry Organization (BIO), as a panelist for the 3rd Alzheimer's focused #C4CT (Coalition for Concussion Treatment) Concussion Awareness Summit, powered by MDM Worldwide on Thursday, July 31, 2014, at the United Nations in New York City, NY.



Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based diagnostics, today announced that an overview of the Company's business and commercial strategy will be given by CGI's Chief Executive Officer, Panna Sharma, at the Canaccord Genuity 34th Annual Growth Conference, being held in BostonAugust 13-14, 2014.



CombiMatrix Corporation (Nasdaq:CBMX)
, a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that it has entered into a contractual agreement with Stratose for coverage of CombiMatrix's diagnostic laboratory services.



Ekso Bionics Holdings, Inc. (OTCQB:EKSO)
, a robotic exoskeleton company, announced today that Kessler Foundation, a global leader in rehabilitation research, has presented preliminary data at World Congress of Biomechanics held in Boston, MA, July 5-10, showing that spinal cord injury (SCI) motor incomplete and complete users were able to actively increase step swing time, stride length and hip extension after walking with an Ekso™ robotic exoskeleton.



Endocyte, Inc., (Nasdaq:ECYT)
announced today that the company will host a conference call on Tuesday, July 29, at 4:30 p.m. EDT to discuss its second quarter 2014 financial results and provide an operational update.



eRAD, a division of RadNet, Inc. (Nasdaq:RDNT)
, an industry leader in Web-based RIS, PACS, and Teleradiology workflow solutions, announced today the company has taken several distributor-based orders from new customers during the second quarter of 2014. eRAD's products and services are available from a number of geographically dispersed valued-added resellers, brokers, and/or distributors in the United States and abroad, as well as direct from the manufacturer.



Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced it has entered into a definitive agreement to license the U.S. rights for the commercial product Zuplenz® (ondansetron) oral soluble film.



K2M Group Holdings, Inc. (Nasdaq:KTWO)
, a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, last week participated in the 21st International Meeting on Advanced Spine Techniques (IMAST) in Valencia, Spain.



MediWound Ltd. (Nasdaq:MDWD),
a fully-integrated, biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release financial results for the three and six months ended June 30, 2014, before the market open on Thursday, July 31, 2014.



MELA Sciences, Inc. (Nasdaq:MELA)
, developer of the MelaFind® system, an optical diagnostic device approved for use in the U.S. and the European Union to assist dermatologists in melanoma diagnosis, announced today that it entered into a definitive securities purchase agreement with entities affiliated with institutional investors in connection with a private placement of approximately $15.0 million aggregate principal amount of senior secured convertible debentures, 12,300 shares of Series B convertible preferred stock at a price of $1,000 per share, and warrants to purchase approximately 11.2 million shares of common stock at an exercise price of $2.45 per share.



MTBC (Nasdaq: MTBC)
, a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, announced the pricing of its initial public offering of 4,080,000 shares of common stock at $5.00 per share.



Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ)
, the leading developer and provider of clinically relevant imaging solutions for use in surgical and diagnostic procedures, will announce financial results for the second quarter of 2014 before markets open on Tuesday, August 5, 2014.



Nymox Pharmaceutical Corporation (Nasdaq:NYMX)
is pleased to announce new positive efficacy data for U.S. Study NX02-0022, the Company's repeat injection study of NX-1207 for BPH.



Quotient Limited (Nasdaq:QTNT)
, a commercial-stage diagnostics company, today announced that financial results for its fiscal first quarter ending June 30, 2014 will be released after market close on Monday, August 4th, 2014.



Roka Bioscience, Inc. (Nasdaq:ROKA)
, a molecular diagnostics company focused on providing advanced testing solutions for the detection of foodborne pathogens, will visit the NASDAQ MarketSite in Times Square.



Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
, a global biopharmaceutical company, today announced that it will host its second quarter 2014 financial results teleconference and webcast at 8:30 a.m. Eastern on Tuesday, August 5, 2014.



ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
, a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the expansion of synthetic immuno-oncology programs in conjunction with Intrexon Corporation (NYSE:XON) to include chimeric antigen receptor T-cell (CAR-T) therapy.


For more stories covering the world of technology, please see HispanicBusiness' Tech Channel



Source: BioMed Reports


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