CEL-SCI Expands its Global Phase III Cancer Trial in Canada; Oncothyreon Plunges On Drug Fail Print E-mail
By Mary Davila   
Tuesday, 19 August 2014 19:19
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 19 2014.
CEL-SCI Corporation (NYSE MKT: CVM) announced its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) has added Centre Hospitalier Universitaire de Québec (CHUQ)’s L’Hotel Dieu de Quebec to its growing number of clinical sites in North America. CHUQ is a network of three teaching hospitals affiliated with the medical school of Université Laval and several specialized institutions in Quebec City. CEL-SCI plans to activate additional clinical sites for accelerated patient enrollment in Canada.

The Principal Investigator for CEL-SCI’s Phase III trial at CHUQ is Dr. André Fortin, a radiation oncologist and visiting professor.  He is responsible for the research protocols of radiation therapy for the oncology group at CHUQ. Dr. Fortin has extensive expertise in the treatment of cancers using radiation therapy for head and neck, pulmonary, and digestive cancers. He is very involved in clinical research within the department as evidenced by his numerous publications.

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. CEL-SCI’s Multikine investigational immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of these patients.

“We are adding many additional centers in Canada and the U.S. for the world’s largest Phase III trial in head and neck cancer. This will hopefully keep us on schedule to complete global enrollment with approximately 880 patients by the end of 2015,” stated CEL-SCI Chief Executive Officer Geert Kersten.



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 Oncothyreon (NASDAQ: ONTY)
plunged Tuesday after the company's tecemotide lung cancer treatment failed to show any effects in a trial in Japan.

Merck KGaA has exclusive rights to develop and commercialize the drug and informed Oncothyreon it would discontinue the Phase I/II study.

Tecemontide is one of four drugs in Oncothyreon's pipeline and Wedbush's Gregory Wade said the lack of tecemotide results in Japan raises doubts about the company's ONT-10 cancer drug.

Both tecemotide and ONT-10 stimulate the immune system to recognize and attack cells that express MUC1, a protein found on non-small cell lung, breast, colon, kidney, ovarian, pancreatic and prostate cancers.  ONT-10 is currently being evaluated in Phase I clinical trials in patients with solid tumors.

Wade maintained an Outperform rating on Oncothyreon, but cut his target from $6 to $3 per share.  Oncothyreon traded recently at $2.26, down 18.7 percent.




Also Tuesday:




Accuray Incorporated (Nasdaq:ARAY)
, announced today that its management is scheduled to present at the 2014 Morgan Stanley Global Healthcare Conference in New York City on Monday, September 8, 2014 at 12:50 p.m. ET/ 9:50 a.m. PT.

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
today announced that the U.S. Patent & Trademark Office has granted Achillion U.S. Patent No. 8,809,313, covering composition-of-matter and method of use claims for ACH-3102 and structurally related NS5A inhibitor compounds. ACH-3102 is Achillion's second generation Phase 2 NS5A inhibitor being investigated for the treatment of chronic hepatitis C virus (HCV) infection.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging pharmaceutical 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, announced today that the first patient has been enrolled in a Phase IIb Fragile X study of MDX.

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 that Gerald Commissiong, President and CEO, is scheduled to present to investors at the 16th Annual Rodman & Renshaw Healthcare Conference to be held September 8-10, 2014 at the New York Palace Hotel in New York City.

Anavex Life Sciences Corp. (OTCQB:AVXL)
, a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, announced today new data published in the current issue of Cell Death and Disease that the commonly used selective serotonin reuptake inhibitor (SSRI) Fluvoxamine has a high affinity for sigma-1 receptor (S1R) and thus can alleviate cell stress.

Auris Medical Holding AG (NASDAQ: EARS)
announced today that the underwriters of its initial public offering have exercised their over-allotment option to purchase an additional 713,235 shares of common stock.

Enzymotec Ltd. (Nasdaq:ENZY)
announced that it will hold an Annual General Meeting of Shareholders on Monday, September 29, 2014.

MRI Interventions, Inc. (OTCQB:MRIC)
today announced that neurosurgeons at UC San Diego Health System have utilized the ClearPoint® system's platform capabilities to facilitate three same-setting MRI-guided neurosurgical procedures for a single patient.

Radius Health, Inc. (Nasdaq:RDUS)
announced today that it will present new data from multiple studies of abaloparatide in women with postmenopausal osteoporosis at the American Society for Bone and Mineral Research (ASBMR) 2014 Annual Meeting, which takes place September 12-15, 2014 in Houston, Texas.

Sharps Compliance Corp. (Nasdaq:SMED)
announced today that David P. Tusa, President and Chief Executive Officer, will be presenting at the Baird Healthcare Conference to be held at the New York Palace Hotel.

SpectraScience, Inc. (OTCQB:SCIE)
today announced the Company will hold a conference call at 4:30 p.m. Eastern (1:30 p.m. Pacific) on August 26, 2014 to provide an update on its business.

Sunshine Heart, Inc. (Nasdaq:SSH)
today announced that the current condition of a heart failure patient implanted with the C-Pulse® System improved after six weeks of treatment, allowing him to attend his daughter's wedding.

Terra Tech Corp (TRTC)
is pleased to announce their subsidiaries MediFarm, MediFarm I and Medifarm II have submitted their applications to operate Medical Marijuana Enterprises (MME) to the state of Nevada. 

Urologix®, Inc. (OTCQB:ULGX)
, the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today reported financial results for its fourth quarter and fiscal year ended June 30, 2014.



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