News Column

BrainStorm's Clinical Trial is Fast-Tracked to Phase IIa; CEL-SCI Expands Its Phase III Head and Neck Cancer Trial

July 17, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on July 17, 2014.

{nfg}BrainStorm Cell Therapeutics (OTC.QB: BCLI)
, a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the Israeli Ministry of Health has fast-tracked its current Phase I/II ALS safety trial to a Phase IIa dose-escalating trial, significantly expediting the company’s clinical development program and saving valuable time. The trial, which will evaluate the safety and preliminary efficacy of BrainStorm’s NurOwn stem cell therapy candidate, will be launched immediately at the Hadassah Medical Center in Jerusalem.



The Ministry of Health approved acceleration to a Phase IIa trial based on evaluation of only 12 of the initial cohort of 24 patients in the company’s Phase I/II trial at Hadassah. In the Phase IIa trial, the second group of 12 patients will receive combined intramuscular and intrathecal administration of NurOwn cells in three cohorts, with increasing doses. The study participants, who have already been recruited, will be followed for three to six months after transplantation.



“Acceleration to Phase IIa will save us critical time, enabling us to proceed much more quickly with achieving our goal of developing an effective treatment for ALS,” commented Dr. Adrian Harel, BrainStorm’s CEO.



Professor Dimitrios Karussis, Principal Investigator of BrainStorm’s Phase I/II trial at Hadassah, commented: “Based on the positive results we have seen for the first 12 patients, we are eager to begin the next stage of clinical testing, and are delighted that the Ministry of Health has given us the green light to proceed to Phase IIa.”



BrainStorm has been conducting a Phase I/II clinical trial in ALS patients at the Hadassah Medical Center in Jerusalem since June 2011, and plans to launch the Phase IIa study immediately. The company is also planning to expand its clinical development to the United States in 2013, pending FDA approval. Towards that goal, the Company has entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS human clinical trials at these institutions.





=======================



CEL-SCI Corporation (NYSE MKT: CVM)
announced Sri Lanka’s Ministry of Health has cleared the Company to commence patient enrollment for its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Sri Lanka. This follows similar clearance to conduct the Phase III study in the UK and Austria during the past weeks. Further expansion of the trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers in 20 countries by the end of 2015.



CEL-SCI’s global pivotal Phase III clinical trial is the largest trial for head and neck cancer in the world. The trial, which already has over 220 patients enrolled, is assessing the Company’s investigational immunotherapeutic agent Multikine 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.



“If Multikine can be proven to harness the immune system against cancer, we believe this could offer a new modality for the treatment of head and neck cancer that could work in concert with the other methods – surgery, chemotherapy, and radiation therapy, used today for the treatment of this debilitating disease.” stated CEL-SCI Chief Executive Officer Geert Kersten.



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.







Also Thursday:





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 pleased to announce their continued support of One Mind at 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.



Alcobra Ltd. (Nasdaq:ADHD)
, an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, held an Investor Forum on Tuesday, July 15, 2014 in New York City.



Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, will release its second quarter 2014 financial results on Thursday, July 31, 2014, after the close of the market.



athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHRs), practice management, and care coordination, today announced financial and operational results for the second quarter of fiscal year 2014.



Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX)
, a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, today announced the enrollment of the first two patients in a multi-center pivotal Phase 2/3 clinical trial of its investigational drug, SD-809 (deutetrabenazine), for the treatment of tardive dyskinesia (TD). Top-line data from the trial, designated the ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) study, are expected in mid-2015.



BioCorRx Inc. (OTCQB: BICX)
, a leader in addiction treatment and rehabilitation programs, announced it has closed a sale for the exclusive license and distribution rights of its Start Fresh Program to Addiction Recovery Centers, LLC ("ARC").



CDW Corporation (Nasdaq:CDW), a leading provider of technology solutions to business, government, education and healthcare, announced that it will host a webcast conference call to discuss its second quarter 2014 results on Thursday, July 31 at 8:30 a.m. ET/7:30 a.m. CT.



Celator Pharmaceuticals, Inc. (Nasdaq:CPXX),
a pharmaceutical company developing new and more effective therapies to treat cancer, today will present updates on its lead candidate CPX-351 and CombiPlex® technology platform at its Analyst Day meeting for analysts and investors.



Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF)
, a specialty pharmaceutical company focused on Parkinson's disease, today announced that following communication from the United States Food and Drug Administration ("the FDA") on July 16, 2014, Phase 2 clinical studies for APL-130277 will commence immediately. Specifically, clinical study CTH-105 will be initiated per the proposal submitted to the FDA under the Company´s Investigational New Drug (IND) application.



Firsthand Technology Value Fund, Inc. (Nasdaq:SVVC)
, a publicly-traded venture capital fund that invests in technology and cleantech companies, disclosed today that its top five holdings as of June 30, 2014 were Twitter, Facebook, IntraOp Medical, Turn, and Pivotal Systems.



Herborium® Group, Inc. (OTC Pink: HBRM), a Botanical Therapeutics® Company and the provider of unique all botanical medicinal products (Botanical Therapeutics®) that target dermatological problems such as acne, and other health and wellness concerns in the areas of sexual performance as well as energy depletion and stress, reports that its sales for the Second Quarter of 2014 grew by 132 % in comparison to the same period of 2013.



Nuvilex, Inc. (OTCQB:NVLX),
a clinical-stage, international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, today announced, in cooperation with its partner Austrianova, the results of a veterinary Phase I/II clinical trial in dogs with mammary tumors who were treated with Cell-in-a-Box® cellulose-based live cell encapsulation plus the widely used anticancer drug cyclophosphamide (Cytoxan®). These results were published in the Public Library of Science journal (PLOS ONE) on July 16, 2014.



RedChip Companies, Inc., today announced it has issued a research profile on Opexa Therapeutics, Inc. (Nasdaq:OPXA), a biotechnology company developing Tcelna® (imilecleucel-T), a novel T-cell immunotherapy for the treatment of Multiple Sclerosis.



Tauriga Sciences, Inc. (OTCQB:TAUG)
, a diversified life sciences company, is responding to a negligent article which disseminated materially false information about the Company.



ZELTIQ® (NASDAQ: ZLTQ)
, a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, announced today that it plans to release its second quarter 2014 financial results on Tuesday, July 29, 2014 after the market close.




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



Source: BioMed Reports


Story Tools






HispanicBusiness.com Facebook Linkedin Twitter RSS Feed Email Alerts & Newsletters