News Column

CEL-SCI Reports 93% Increase in Its Phase III Head and Neck Cancer Trial; Agenus Announces Positive Phase 2 Results

July 1, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on July 1, 2014.

{nfg}CEL-SCI Corporation (NYSE MKT: CVM)announced during the month of June the Company enrolled 19 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). A total of 54 patients were enrolled over the past three months, with 21 enrolled in April, 14 in May, and 19 in June. This marks a 93% increase over the prior three month period when a total of 28 patients were enrolled, with 8 in January, 6 in February, and 14 in March. Since the beginning of 2014, the Company has enrolled a total of 82 patients. This compares with 10 patients enrolled in the first half of 2013.



“As a result of active patient recruitment ongoing in an increasing number of clinical centers around the world, we are seeing the kind of acceleration we expect in patient enrollment numbers. With the United Kingdom having recently cleared our study, we are well past the halfway mark for country approvals. We are looking forward to receiving approvals from multiple additional countries later this year before being fully approved in all participating countries,” stated CEL-SCI Chief Executive Officer Geert Kersten.



So far, a total of 218 patients have been enrolled in the study. The study is expected to complete enrollment of 880 patients by the end of 2015.







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Agenus Inc. (NASDAQ: AGEN)
, announced final results from a single-arm, multi-institutional, open-label, Phase 2 study showing that patients with newly diagnosed glioblastoma multiforme (GBM) who received Agenus' Prophage autologous cancer vaccine added to the standard of care treatment, lived nearly twice as long as expected. In this Phase 2 study, 50% of the patients lived for two years, an encouraging result for a cancer that often kills patients within one year 1-7. Prophage patients demonstrated a median overall survival of approximately 24 months and 33% of patients remain alive at 2 years and continue to be followed for survival.



“These data suggest that Prophage is generating an effective immune response which is translating into an extension in survival far beyond what is historically seen in patients with GBM. These data provide the impetus for a definitive, randomized clinical trial,” said Andrew Parsa, MD, PhD,Principal Investigator of the study and the Michael J. Marchese Professor and Chair of the Department of Neurological Surgery at the Feinberg School of Medicine at Northwestern University. “Glioblastoma tumors are often resistant to standard therapies and the extended progression-free survival and proportion of long-term survivors is very encouraging.”



In addition to the long-term survival data, vaccine treated patients had a median progression-free survival (PFS) of nearly 18 months, approximately two to three-times longer than patients treated with radiation and temozolomide alone1. Importantly, 22% of patients were alive and without progression at 24 months and continue to be followed for survival.



Interestingly, the response to Prophage seems to be more pronounced in those patients with less expression of the checkpoint ligand PDL-1 on the white blood cells, suggesting that combinations of Prophage with checkpoint modulators like PD-1 antagonists might make Prophage even more effective in a greater percentage of patients with GBM.



“We believe that Prophage may play an important role in changing the treatment paradigm for patients with GBM,” said Garo Armen, PhD, CEO and chairman of Agenus Inc. “We are exploring partnerships for Phase 3 studies of Prophage in GBM. Additionally, we are excited about the potential combinations of Prophage with PD-1 antagonists and other checkpoint modulators in GBM.”



Prophage is an autologous cancer vaccine, and each patient receives vaccine prepared from their own surgically resected tumor. As a result, the vaccine appears to help stimulate the patient's immune system to attack the tumor based on the spectrum of mutant proteins expressed by their own tumor. Since most cancers result from an accumulation of random mutations, which produce different mutant proteins in each patient, this approach is intended to individually tailor each patient's vaccine to optimally target the immune attack to that patient's actual tumor.







Also Tuesday:






Abiomed, Inc. (Nasdaq:ABMD)
, a leading provider of breakthrough heart support technologies, announced today that it has acquired ECP Entwicklungsgesellschaft mbH ("ECP"), a medical device company based in Berlin, Germany.



Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
announced that it has been added to the Russell 2000 and Russell Microcap Indexes.



Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced it has independently confirmed MANF's activity in mitigating tau hyperphosphorylation in pre-clinical models of Alzheimer's disease.



Amedica Corporation (Nasdaq:AMDA)
a biomaterial company focused on using its Silicon Nitride technology platform to develop, manufacture and sell a broad range of medical devices, today announced that it has secured up to $26.0 million in additional funding consisting of a $20.0 million debt financing with Hercules Technology Growth Capital, Inc. (NYSE:HTGC), and a private placement to MG Partners II Ltd., an affiliate of Magna ("Magna"), of 6% Senior Convertible Notes in an aggregate principal amount of up to $6 million.



Applied Genetic Technologies Corporation (Nasdaq:AGTC)
, a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced the appointment of Matthew Feinsod, MD, to the position of Product Development Officer.



BioCorRx, Inc. (OTCQB: BICX)
, a leader in addiction treatment and rehabilitation programs, announced it has closed another sale for the exclusive license and distribution rights of its Start Fresh Program to Sobriety and Addictions Solutions, LLC.



Foundation Healthcare, Inc. (OTC Markets:FDNH)
, which focuses on the development and management of surgical hospitals and related ancillary services, announced today the successful completion of a new $27.5 million term loan as well as a $2.5 million revolving credit facility.



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 the notice of allowance of a U.S. Patent for NeuVax™ (nelipepimut-S) covering the use of NeuVax alone or in combination to prevent recurrence of any HER2/neu expressing tumor having a fluorescence in situ hybridization (FISH) rating of less than about 2.0. NeuVax is a peptide immunotherapy for the prevention of cancer recurrence and is Galena's lead development agent in multiple ongoing and planned clinical trials.



GE (NYSE: GE)
today announced that it has agreed to acquire Monsal, a private U.K.-based water, waste, advanced anaerobic digestion and integrated biogas-to-energy business.



GlobeImmune, Inc. (Nasdaq:GBIM)
, today announced the pricing of its initial public offering of 1,500,000 shares of its common stock at a price to the public of $10.00 per share.



Marrone Bio Innovations, Inc. (Nasdaq:MBII)
, a leading global provider of bio-based pest management and plant health products, is celebrating the official opening of its Marrone Michigan Manufacturing (M3) facility today with a ribbon cutting ceremony and plant tours for invited guests.



Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that Chief Executive Officer and President Kenneth L. Waggoner and Chief Operating Officer Dr. Gerald W. Crabtree attended the 2014 BIO International Convention held June 23-26, 2014, in San Diego, California.



PositiveID Corporation (OTCQB:PSID)
, a developer of biological detection and diagnostics solutions, announced today that its Chairman and CEO William J. Caragol has conducted a new, audio-taped webcast interview with The Green Baron Report.



Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, announced the first patient screened and enrolled in the Phase 2 study of the human monoclonal anti-FGF23 antibody KRN23 (UX023) in pediatric patients with X-linked hypophosphatemia (XLH).



Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that it will host a live webcast of its second quarter conference call on Tuesday, July 22nd at 3:30pm CDT.



Zafgen, Inc. (Nasdaq:ZFGN)
, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today announced the appointment of Patrick Loustau to the position of President.


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



Source: BioMed Reports


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