|Cel-Sci Reports Another Record Month for Patient Enrollment for Multikine; SAGE Therapeutics Receives U.S. Orphan Drug Designation for SAGE-547|
|By Staff and Wire Reports|
|Thursday, 01 May 2014 20:16|
CEL-SCI Corporation (NYSE MKT: CVM) today announced that during the month of April 2014 the Company enrolled 21 patients with advanced primary, not yet treated, head and neck cancer into its global Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). This marks a substantial increase over the previous monthly record of 14 patients in March 2014.
CEL-SCI’s trial is now active in 46 clinical centers in 12 countries. Further expansion is underway to a total of about 20 countries and about 100 clinical centers. So far, 183 patients have been enrolled in the study.
“During the past months we have seen very rapid increases in rate of enrollment in this study. We think that increases in the enrollment rate in our trial in recent months are, in part, due to the addition of new centers and the intense site support by our clinical research organization Ergomed. In addition, we have observed a definite increase in interest by investigators in enrolling subjects in our study once they have gained some experience with Multikine in their own patients and once they become more familiar with it. As we continue to add new centers in our study and as the investigators become more experienced with using Multikine, we can expect that the rate of enrollment in our study will continue to increase and make it possible to reach our goal of full enrolment by the end of 2015,” commented Geert Kersten, CEL-SCI’s Chief Executive Officer.
Multikine was reported to be well tolerated and was used safely in CEL-SCI’s Phase II studies in head and neck cancer, as reported by the Phase II study investigators. In the Phase II trial, which formed the basis for the Phase III study, Multikine administration appeared to have caused, on average, the reduction/elimination of about 50% of the cancer cells of treated patients, as determined by pathology. Also, based on pathology reports, about 12% of patients had no remaining cancer cells after their treatment with Multikine Phase II results published (by Timar et al) in the Journal of Clinical Oncology.
About Multikine Phase III Study -- The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
About Multikine -- Multikine* (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.
SAGE Therapeutics (SAGE), a biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its neuroactive steroid, SAGE-547, for the treatment of status epilepticus. SAGE Therapeutics is currently evaluating SAGE-547 in a Phase 1/2 clinical trial for the treatment of super-refractory status epilepticus (SRSE).
“Receiving orphan drug designation may help SAGE with the development of SAGE-547 and may ultimately allow us to deliver this promising medicine to patients who suffer from status epilepticus,” said Jeff Jonas, M.D., chief executive officer of SAGE Therapeutics. “Status epilepticus is a life-threatening disease with limited treatment options, and this advancement demonstrates our commitment to delivering SAGE-547 and other therapies to patients with life-threatening, rare CNS disorders.”
Orphan drug designation, which is intended to facilitate drug development for rare diseases, provides substantial benefits to the sponsor, including the potential for tax credits for clinical development costs, study-design assistance, and several years of market exclusivity for the product upon regulatory approval.
About SAGE-547 -- SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. GABAA receptors are widely regarded as validated drug targets for a variety of CNS disorders, with decades of research and multiple approved drugs targeting these receptor systems. SAGE-547, developed by SAGE Therapeutics using its proprietary chemistry platform, is an intravenous agent in Phase 1/2 clinical development as an adjunctive therapy, a therapy combined with current therapeutic approaches, for the treatment of SRSE.
Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announced today that it will be presenting at two upcoming scientific forums.
Advaxis, Inc., (Nasdaq:ADXS), a leader in developing cancer immunotherapies, announced today that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead immunotherapy drug candidate, for the treatment of Stage II-IV invasive cervical cancer.
Air Methods Corporation (Nasdaq:AIRM) will report financial results for the first quarter ended March 31, 2014 after the close of the market on Thursday, May 8, 2014.
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, today announced that the United States Patent and Trademark Office ("USPTO") has issued a new patent covering MDX's use in the treatment of Cognitive Disorders.
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, today announced the publication of positive independent peer-reviewed data on MANF in the areas of Alzheimer's disease and Diabetes, as well as additional studies further supporting its critical role in proper cellular function.
Amicus Therapeutics (Nasdaq:FOLD) today announced a conference call and live audio webcast on Monday, May 5, 2014 at 5:00 p.m. ET to discuss financial results for the first quarter ended March 31, 2014.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced that it will participate in the Baird 2014 Growth Stock Conference in Chicago.
CAS Medical Systems, Inc. (Nasdaq:CASM), a leader in medical devices for non-invasive patient monitoring, today reported financial results for the three months ended March 31, 2014.
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the first quarter ended March 31, 2014.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today details relating to its first quarter 2014 results announcement, which will take place on Thursday, May 15, 2014, before the opening of the market.
Endocyte, Inc. (Nasdaq:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced that the company has rescheduled the call of its first quarter 2014 financial results and business update to Friday, May 2, at 8:30 a.m. EDT.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, will report its first quarter 2014 financial results on Thursday, May 8, 2014 after the U.S. financial markets close.
Immunomedics, Inc., (Nasdaq:IMMU) today announced that it is offering to sell, subject to market and other conditions, shares of its common stock pursuant to an effective shelf registration statement. In connection with this offering, Immunomedics intends to grant the underwriters a 30-day option to purchase additional shares of common stock.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, will present at the Deutsche Bank 39th Annual Health Care Conference on Thursday, May 8, 2014, at 1:30 P.M. Eastern Time in Boston, MA.
LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, announced today that its most recent study on Protandim was presented at the 2014 Experimental Biology Conference held April 26-30, in San Diego, California.
NanoString Technologies, Inc. (Nasdaq:NSTG), today announced that its management is scheduled to participate in the Bank of America Merrill Lynch Healthcare Conference in Las Vegas.
Novavax, Inc. (Nasdaq:NVAX) announced today that it will report its first quarter 2014 financial results on Wednesday, May 7, 2014 after the close of the U.S. financial markets.
Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that world renowned oncologist and gastroenterologist Professor Dr. Matthias Löhr of the famed Karolinska Institute in Stockholm, Sweden, has agreed to play a major role in Nuvilex's Phase 2b clinical trial in pancreatic cancer to be conducted in Australia, as well as other clinical studies and trials in which Nuvilex will be involved.
PMX Communities Inc. (OTCQB:PMXO) and their subsidiary PMX Gold Bullion Sales Inc., announces completion of their cannabis dispensing terminal.
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, announced today that it will host a live webcast and conference call on Friday, May 2, 2014 at 4:30 p.m. ET (or 1:30 p.m. PT) to review interim clinical data from the ongoing Phase 1 study of NEOD001 presented as part of the poster session at the XIV International Symposium on Amyloidosis earlier this week.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that its Chief Financial Officer, Graham Cooper, will be presenting at the Deutsche Bank Securities Annual Healthcare Conference at the InterContinental Hotel in Boston.
SIGA Technologies, Inc. (Nasdaq:SIGA), a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today reported its financial results for the quarter ended March 31, 2014.
StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, announced today that it will release financial results for the first quarter ended March 31, 2014 after the market close on Wednesday, May 14.
TESARO, Inc. (Nasdaq:TSRO) announced today that Lonnie Moulder, CEO of TESARO, and Dr. Mary Lynne Hedley, President of TESARO, will present at the Deutsche Bank Securities 39th Annual Health Care Conference on Wednesday, May 7, 2014 at 1:30 p.m. Eastern time at the InterContinental Hotel Boston.
TriVascular Technologies, Inc. (Nasdaq:TRIV) today announced that the Company will release 2014 first quarter financial results after market close on Wednesday, May 14, 2014.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to participate in the Bank of America Merrill Lynch 2014 Health Care Conference being held at The Encore at Wynn Hotel in Las Vegas.