Provectus’ Data on PV-10 as Treatment of Melanoma; CEL-SCI Reports Patient Enrollment in Phase 3 Cancer Trial Print E-mail
By Mary Davila   
Tuesday, 02 June 2015 01:08
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 1, 2015.  
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or the “Company”), announced today that Dr. Sanjiv Agarwala, chief of medical oncology and hematology at St. Luke’s Cancer Center in Bethlehem, Pennsylvania, and professor of medicine at Temple University School of Medicine in Philadelphia, presented data on PV-10 as an investigational intralesional treatment of melanoma at the 2015 American Society of Clinical Oncology’s Annual Meeting on May 31, 2015. A copy of the presentation can be found at: http://www.pvct.com/presentation/A_Changing_topography_IL_Rx_in_Melanoma.pdf
   
Dr. Agarwala chaired an education session titled “Locoregional Therapies in the Setting of Systemic Treatment Advances: What’s Next?” The session was part of the conference’s track: Melanoma/Skin Cancers; Developmental Therapeutics and Translational Research.
  
He identified the potential goals of intralesional treatment as local disease control (durable tumor shrinkage and symptom control and palliation), systemic effect (immune mediated), delay or prevention of systemic therapy and neoadjuvant potential. Next, the session covered the phase 3 trial results for TVEC, the phase 2 results for PV-10 as well as a review of the newly begun phase 3 trial for PV-10, a review of the phase 2 results for DNA IL-12, pIL-12 Monotherapy, and Coxsackievirus A21 (CVA21). Among the conclusions in the session, Dr. Agarwala stated that “several agents in development appear promising.”
 
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CEL-SCI Corporation (NYSE MKT: CVM) announced in May it has enrolled 26 patients in its ongoing Phase III trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer. Over 463 patients have been enrolled as of May 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.
  
“We are now cleared to enroll patients in 23 countries and a number of additional clinical sites are expected to become active soon.”
   
“With over half of patients enrolled, we have reached a milestone, as we look forward to completing enrollment by the first quarter of 2016,” stated CEL-SCI Chief Executive Officer Geert Kersten. “We are now cleared to enroll patients in 23 countries and a number of additional clinical sites are expected to become active soon.”
   
A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in about 25 countries.
   
    
Also Monday:
   
   
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that Michael R. Minogue, Chairman, President and CEO, will present at the Jefferies 2015 Global Healthcare Conference on Wednesday, June 3, 2015 at 2:00 p.m. ET. 
   
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that Robert Bowen, the Company's Vice President and Chief Financial Officer since 2008, who will celebrate his 66th birthday this summer will retire from Abiomed next month and that Michael Tomsicek will be appointed as Vice President and Chief Financial Officer, effective July 15, 2015. 
   
DS Healthcare Group, Inc. (Nasdaq:DSKX), today announced a channel incentive rewards program that will open for enrollment in July.
   
Entellus Medical, Inc. (Nasdaq:ENTL), a medical technology company focused on designing, developing and commercializing products for the minimally invasive treatment of chronic and recurrent sinusitis patients, today announced the European launch of the XprESS™ LoProfile Multi-Sinus Dilation System. 
   
FibroGen, Inc. (Nasdaq:FGEN), a research-based biopharmaceutical company, today announced that management will present a company overview at the Goldman Sachs 36th Annual Global Healthcare Conference on June 10, 2015 at 2:00 p.m. PT.
   
Fibrocell Science, Inc. (Nasdaq:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced the appointment of Michael F. Marino as Senior Vice President, General Counsel and Corporate Secretary, effective immediately.
    
Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced today that Dr. Dov Tamarkin, Chief Executive Officer, will provide a corporate overview and business update at the Jefferies 2015 Global Healthcare Conference.
    
HealthEquity, Inc. (Nasdaq:HQY), one of the largest HSA non-bank custodians, today announced that the company will release the results for its first quarter ended April 30, 2015 after the market closes on Monday, June 8, 2015. 
   
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications and The University of Texas MD Anderson Cancer Center have entered into a 2-year Sponsored Research Agreement to support development of multiple next-generation sequencing (NGS)-based gene expression assays for lung cancer subtyping, fusion status and immune profiling.
   
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, today reported financial results for the three months ended March 31, 2015.
    
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, announced today that it has appointed Ron Greeno, M.D., FCCP, MHM to the newly created position of Chief Strategy Officer, where he will be responsible for leading the company's strategic initiatives.
    
Materialise NV (Nasdaq:MTLS), a leading provider of 3D software and sophisticated 3D printing solutions, and pioneer in medical image based knee guide technology, today announced that Consensus Orthopedics Inc. will use its Knee Guide System.
    
Matinas BioPharma Holdings, Inc. (OTCQB:MTNB), a clinical-stage biopharmaceutical company, today announced top-line results for its head-to-head comparative pharmacokinetic and pharmacodynamic study versus Vascepa® (icosapent ethyl). 
    
MediWound Ltd. (Nasdaq:MDWD), a fully-integrated, biopharmaceutical company developing, manufacturing and commercializing innovative therapies to address unmet needs in severe burn and wound management, announces that Company management participate at the Jefferies 2015 Global Healthcare Conference taking place from June 1-4, 2015 in New York City. 
    
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, will present updated data from the Phase 1 trial evaluating necuparanib in combination with nab-paclitaxel (nabP; Abraxane®) and gemcitabine (GEM) in patients with advanced metastatic pancreatic cancer (ClinicalTrials.gov Identifier NCT01621243) at the 2015 ASCO Annual Meeting, today from 8:00 to 11:30 am CDT (Abstract #4114).
    
Premier, Inc. (Nasdaq:PINC) has introduced CommunityFocus, an automated, cloud-based SaaS (software-as-a-service) solution designed to help health systems easily acquire, integrate and manage community-level health data, as well as create targeted interventions to improve population health management.
    
Protea Biosciences Group, Inc. (OTCQB:PRGB) announced today a new, silicon chip technology that enables the rapid identification and quantitation of small molecules in biofluids.
    
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that the Centers for Medicare and Medicaid Services (CMS) has granted a unique product reimbursement code for Triferic. 
    
StemCells, Inc. (Nasdaq:STEM) today announced that the underwriters of the Company's public offering that initially closed on April 29, 2015 have purchased an additional 2,757,250 shares of the Company's common stock at a price of $0.699 per share, before the underwriting discount, in connection with the exercise of their option to purchase additional shares of common stock (the "Over-Allotment Option"). 
    
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the Jefferies 2015 Healthcare Conference on Wednesday, June 3, 2015 at 3:00 PM ET. 
     
Terra Tech Corp  (TRTC) subsidiary, MediFarm is pleased to announce they are beginning construction within the next 30 days on their medical cannabis dispensary located in the City of Las Vegas. MediFarm's 3,900 sq. ft. facility is located adjacent to the Las Vegas strip at 1921 Western Avenue. 
    
TG Therapeutics, Inc. (Nasdaq:TGTX), today announced clinical results from its ongoing study with TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody in combination with the Company's oral, once-daily, PI3K delta inhibitor, TGR-1202 and ibrutinib, a BTK inhibitor.  Data from this Phase I dose escalation study was presented today by Dr. Nathan Fowler, Director, Developmental Therapeutics, Department of Lymphoma, MD Anderson Cancer Center at the Lymphoma Oral Session during the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.



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