|Provectus Submits Application to FDA for PV-10; GE Completes Acquisition of Strategic Assets from Thermo Fisher Scientific|
|By Staff and Wire Reports|
|Monday, 24 March 2014 18:34|
Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has applied to the FDA for Breakthrough Therapy Designation (BTD) for PV-10 for the treatment of melanoma. FDA guidelines state that the Agency will make a decision on the application within 60 days of receipt. The Agency's records for FY 2013 show that the Agency's Center for Drug Evaluation and Research (CDER) met that guideline 97% of the time.
Craig Dees, PhD, CEO of Provectus said, "The decision to apply for BTD stems from our Type C meeting held with the FDA's Division of Oncology Products 2 in December 2013. At the meeting FDA expressed willingness to work with Provectus toward initial approval for the novel investigational oncology drug PV-10 in locally advanced cutaneous melanoma. This included a statement in the minutes that data in a cohort of patients that received PV-10 to all existing lesions should be submitted in a formal BTD application."
Dees continued, "I want to make clear to our shareholders, the media and the market as a whole that BTD is not guaranteed and if the designation is conferred on PV-10 for melanoma, it does not bypass the need for a new drug application (NDA) and review, as both are required for commercialization of any drug. As I have stated previously, the Agency may yet recommend and it may be in the best interest of Provectus to undertake a small, short bridging study in patients where all tumor burden can be injected. This could occur either before or after we have approval to sell PV-10. Provectus has over $16 million in cash reserves and would not require additional capital or the resources of a partner to conduct such a study. If such a study is conducted, it also fits with needs for an international study supportive of licensure in Australia, Europe, China and India."
Dees concluded, "We are confident that the studies done thus far illustrate the effectiveness and safety of PV-10: if you inject PV-10 into melanoma tumors, the tumors go away. For recurrent, aggressive skin cancers this unique mechanism confers tangible benefit to patients."
In addition to PV-10 for melanoma, Provectus has recently initiated patient enrollment at St. Luke's Hospital in Bethlehem, PA, for protocol PV-10-LC-01, which is assessing safety and preliminary efficacy of PV-10 for treatment of tumors of the liver. This is the third site participating in the study, in addition to Sharp Memorial Hospital, San Diego, CA and The Southeastern Center for Digestive Disorders & Pancreatic Cancer, Tampa, FL.
Furthermore, St. Luke's, Sharp Memorial, M.D. Anderson Cancer Center in Houston, TX, and the University of Louisville in Louisville, KY, as well as key Australian centers, are participating in the expanded access study PV-10-EA-02, which affords access to PV-10 to patients with cutaneous or subcutaneous cancers who have exhausted all other treatment options.
FDA Expected to Make Determination Within 60 Days upon Receipt.
GE (NYSE:GE) announced it has completed the acquisition of Thermo Fisher’s HyClone™ cell culture media and sera, and gene modulation and magnetic beads businesses. The acquisition allows GE to expand its offering of tools, technologies and services for the discovery and manufacture of innovative new medicines, vaccines and diagnostics in its growing Life Sciences business.
Commenting on the close, Kieran Murphy, President and CEO of GE Healthcare’s Life Sciences business said, “GE Healthcare has built a world-class set of technologies for the life sciences sector, and these new businesses will strongly enhance our current offerings. As well as providing us with new tools for drug discovery and biomedical research, our customers in biopharmaceutical manufacturing will benefit straight away from an expanded range of “start-to-finish” technologies that will help them improve product yields and reduce time-to-market. Through this acquisition we immediately expand our cell culture media production capabilities in Asia, the Americas and Europe, enabling us to offer the biopharmaceutical industry greater confidence in the security of supply of a key part of their production process”.
Alliqua, Inc. (Nasdaq:ALQA), a provider of advanced wound care products and custom manufacturing solutions to partners in the medical device and cosmetics industry, reports its financial results for the quarter and year ended December 31, 2013.
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced the election of Dr. Claire Pomeroy to its Board of Directors.
Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in Circulating Tumor Cells (CTCs), Circulating Tumor DNA (ctDNA) and biomarker analysis, today announced that it has appointed Raaj Trivedi as Vice President - Commercial Operations.
Brooks Automation, Inc. (Nasdaq:BRKS), a global provider of automated sample storage systems for compound management and biorepositories, and BioCision, LLC, a leader in advanced technology to improve biomaterial sample handling and standardization, today announced they have established a relationship to support the development of technologies to improve temperature control and standardization in the use of biomaterials across multiple industries, including pre-clinical and clinical research and product development.
Cannabis Therapy Corp. (OTCQB: CTCO) (formerly OTCQB: FWSI) today announced it has received a listing for quotation with immediate effect on OTC Markets under the symbol "CTCO" as assigned by the Financial Industry Regulatory Authority, Inc. (FINRA).
Capstone Therapeutics (OTCQB:CAPS), will hold a conference call and webcast on Thursday, March 27, 2014 at 4:30 pm EDT.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products, today announced that the Company plans to release its financial results for the full year of 2013 ended December 31, 2013 on Monday, March 31, 2014, after the stock market closes.
Elite Pharmaceuticals, Inc. (OTCBB:ELTP) today announced that on March 21, 2014, the Company filed a Changes Being Effected in 30 Days (CBE-30) supplemental application with the U.S. Food and Drug Administration (FDA) for the site transfer of manufacturing for Isradipine 2.5 mg and 5 mg tablets to Elite's Northvale facility.
Fortitude Group, Inc. (OTC: FRTD) announced today their successful launch of 420cashcard.com.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB) participated in the 11th Biennial International Research and Clinical Conference held in San Francisco, California, USA, on March 20-23, 2014.
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it intends to file an appeal to challenge the Oslo, Norway District Court's decision in a patent invalidity case concerning Idenix's co-owned Norwegian patent NO 330 755 that covers certain 2'-methyl-2'-fluoro nucleoside compounds useful in the treatment of the hepatitis C virus (HCV) and other flaviviridae infections.
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced three poster presentations featuring clinical and preclinical data for the Company's nucleotide prodrug, IDX21437, and for samatasvir, Idenix's once-daily pan-genotypic NS5A inhibitor, at The International Liver Congress™ 2014, the 49th annual meeting of the European Association for the Study of the Liver (EASL), taking place in London, April 9-13, 2014.
IntelliCell BioSciences, Inc. (OTCQB: SVFC), a regenerative medicine company utilizing adult autologous vascular cells (SVCs) derived from the blood vessels found in adipose tissue, announced today that it will be entering into a research collaboration with Dr. Manuel Trujillo, Clinical Psychiatry NYU Department of Psychiatry and Medical Director of the Amen Clinic, to use its unique approach to the harvest and use of autologous adipose derived stromal vascular fraction cells (SVFC) for clinical studies of ALS (Lou Gehrig's Disease).
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, announced today that its genetically engineered spider silk, Monster Silk™, production program has more than doubled in productivity.
Lion Biotechnologies, Inc. (OTCQB:LBIO), a biotechnology company focused on the development and commercialization of novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TILs), today announced that Chief Executive Officer Manish Singh, Ph.D., will be presenting at the 4th Annual Cancer Immunotherapy Conference at the New York Academy of Medicine in New York City.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that Tesaro, Inc. will use Myriad's novel HRD (homologous recombination deficiency) test to identify tumor types that may respond to its investigational poly-ADP ribose polymerase (PARP) inhibitor, niraparib, currently in Phase 3 clinical development. Specific terms of the deal were not disclosed.
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, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Triferic (soluble ferric pyrophosphate citrate), the Company's late-stage investigational iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.
SK3 Group's (OTC Pink: SKTO) (PINKSHEETS: SKTO) Medical Greens subsidiary is pleased to announce that it now has an additional new distributor in the San Francisco Bay Area in California for its wholesale managed collective portfolio.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today reported its financial results and business highlights for the fourth quarter and year ended December 31, 2013.
United-Guardian, Inc., (Nasdaq:UG) announced today that both earnings and sales set new company records in FY-2013.