CEL-SCI Expands Its Pivotal Phase III Immunotherapy Cancer Trial; Karyopharm to Present Clinical Data Update for Selinexor (KPT-330) Print E-mail
By Josh Gee   
Monday, 08 December 2014 19:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 8, 2014.
CEL-SCI Corporation (NYSE MKT: CVM) announced during November it has added seven new clinical sites to its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection).  Patient screening has begun at new clinical centers in France, Turkey, Poland, Sri Lanka, Russia and Taiwan. 

“The addition of these seven centers is one of the ways in which we intend to increase patient enrollment beyond the 800% year-over-year increase we have already achieved between 2013 and 2014. By conducting a study on this global scale, in the U.S. and about 20 other countries, we are not only increasing the speed of enrollment, but are also positioning CEL-SCI, pending favorable clinical results, to apply for marketing approval in the U.S. and the majority of regulatory agencies around the world,” stated CEL-SCI Chief Executive Officer Geert Kersten.

A total of 880 patients are expected to be enrolled through over 100 clinical sites in about 20 countries by the end of 2015 in the world’s largest Phase III trial for head and neck cancer.

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 the 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.


 
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Karyopharm Therapeutics Inc. (NASDAQ: KPTI)
, a clinical-stage pharmaceutical company, today announced the presentation of positive clinical and preclinical combination data in multiple myeloma for its lead product candidate, Selinexor (KPT-330), a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE(TM) compound, at the 56th American Society of Hematology (ASH) Annual Meeting, held December 6-9, 2014 in San Francisco.

"We are encouraged to see the clinical response rates afforded by adding Selinexor to currently approved multiple myeloma therapies, including dexamethasone and carfilzomib," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "Given the promising durability and preclinical support for synergistic activity with approved agents, we look forward to further evaluating the clinical benefits of Selinexor combination therapy in multiple myeloma."

In an ongoing Phase 1 clinical trial being conducted by Karyopharm, Selinexor in combination with low-dose dexamethasone demonstrated high rates of durable responses, including a 67% overall response rate (partial response or better) and an 89% clinical benefit rate (minimal response or better) in nine evaluable patients with heavily pre-treated and refractory multiple myeloma (one patient was not evaluable for response). Six of these patients remained on study for at least 16 weeks, including two for 28 and 43 weeks, respectively, who remained on study as of December 1, 2014. The overall median duration of response (DOR), which measures time from response to progression, is approximately 7 months.

A Phase 1/2 investigator sponsored study (IST) to evaluate tolerability and efficacy of the combination of Selinexor with the proteasome inhibitor carfilzomib (Kyprolis(R)) and low-dose dexamethasone (Car-Dex) is being conducted by the University of Chicago. In the first three treated patients, all of whom have myeloma refractory to carfilzomib and dexamethasone, Selinexor-Car-Dex induced one very good partial response (VGPR) and two partial responses (PR) with good tolerability. Dose escalation in this Phase 1 clinical study is ongoing.

In a related preclinical study conducted at the University of Chicago, Selinexor combined with carfilzomib induced both autophagy and apoptosis in multiple myeloma cell lines and patient samples, suggesting synergy through a combination-based priming effect. The combination had minimal effects on normal lymphocytes.

"Although early, the activity demonstrated with Selinexor in combination with carfilzomib and dexamethasone in these heavily pretreated patients with carfilzomib- and dexamethasone-refractory multiple myeloma in this ongoing clinical study is very encouraging," said Andrzej Jakubowiak, MD, PhD, Professor of Medicine, Director, Myeloma Program, University of Chicago. "Despite the advent of several new treatments for multiple myeloma, patients continue to have relapsed and refractory disease, and new agents with distinct mechanisms of action are needed."


 
Also Monday:

 

Advaxis, Inc. (Nasdaq:ADXS)
, a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study to evaluate the combination of ADXS-PSA (ADXS31-142) with KEYTRUDA® (pembrolizumab), marketed by Merck & Co., Inc., in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).

Agios Pharmaceuticals, Inc. (Nasdaq:AGIO)
, a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today presented the first clinical data from its Phase 1 single (SAD) and multiple ascending dose (MAD) clinical trials of AG-348 in healthy volunteers.

Agios Pharmaceuticals, Inc. (Nasdaq:AGIO)
, a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced that Celgene Corporation has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement.

Amarantus BioScience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the development of diagnostics and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced the appointment of Joseph Rubinfeld, Ph.D. to its Board of Directors.

Amedica Corporation (Nasdaq:AMDA)
, a biomaterial company that has developed silicon nitride ceramics as a material platform to manufacture and commercialize orthopaedic implants, announced today that it has closed the previously announced firm commitment underwritten public offering of units on November 26, 2014. Amedica issued 11,441,646 units at a price to the public of $1.14 per unit.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today it has been licensed by the Clinical Laboratory Improvement Amendments (CLIA) to perform Focus::CLL™, the company's unique next-generation sequencing (NGS)-based panel for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Calithera Biosciences, Inc. (Nasdaq:CALA)
, a clinical stage biotechnology company focused on the development of novel cancer therapeutics, today announced preclinical data for its lead anti-cancer therapeutic candidate, CB-839, at the American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco, California.

Coherus BioSciences, Inc. (Nasdaq:CHRS)
, a late-stage clinical biologics platform company focused on the global biosimilar market, today announced that it will present at the 33rd Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2015, at 9:30 a.m. PT at the Westin St. Francis Hotel in San Francisco, CA.

Corium International, Inc. (Nasdaq:CORI),
a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced the appointment of Ivan Gergel, M.D. to the Company's Board of Directors.

Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, will present today an overview of the effects of using its nutrient-rich media (NRM) formulation in the ex vivo programming of CD34+ cells sourced from umbilical cord blood.

Flexion Therapeutics, Inc. (Nasdaq:FLXN)
today announced that it is offering to sell 3,500,000 shares of common stock in an underwritten public offering.

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that data from the Company's Phase 1 clinical trials of GALE-401, or Anagrelide Controlled Release (CR), were presented at the 56th American Society of Hematology (ASH) Annual Meeting & Exposition.

Idera Pharmaceuticals, Inc. (Nasdaq:IDRA)
, a clinical-stage biopharmaceutical company developing nucleic acid therapeutics for patients with cancer and rare diseases, today announced that data for its lead product candidate IMO-8400 were presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
today announced that Ron Bentsur, the Company's Chief Executive Officer, will present at the Oppenheimer & Co. Inc. 25th Annual Healthcare Conference, taking place December 10-11 in New York City.

NeoStem, Inc. (Nasdaq:NBS)
, a biopharmaceutical company developing novel cell based therapeutics, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), announced today that PCT has been awarded re-accreditation by AABB (formerly known as the American Association of Blood Banks) in the category of "Cell Therapy Activity: Cord Blood – Processing, Storage and Distribution" for its Allendale, NJ facility.

Nuvilex, Inc. (OTCQB:NVLX)
, a preclinical and clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that it has changed the name of its subsidiary, Medical Marijuana Sciences, Inc., to Viridis Biotech, Inc.

Prosensa Holding N.V. (NASDAQ: RNA)
, the biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with a high unmet medical need, is delighted to have won the Scrip 'Biotech Company of the Year' Award for 2014, announced last week in London, UK.

Proteon Therapeutics Inc. (Nasdaq:PRTO)
, a company developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases, announced today that Company management will present at the Oppenheimer 25th Annual Healthcare Conference in New York City on Thursday, December 11, 2014 at 8:35 am ET.

Prothena Corporation plc (Nasdaq:PRTA)
, a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve amyloid or cell adhesion, announced that Tran Nguyen, the Company's Chief Financial Officer, will be presenting at the Oppenheimer 25th Annual Healthcare Conference on Thursday, December 11, 2014, at 10:55 AM EST.

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS)
today announced the presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

TG Therapeutics, Inc. (Nasdaq:TGTX)
, today announced clinical results from its Phase 2 study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib (IMBRUVICA®), the oral BTK inhibitor from Pharmacyclics (Nasdaq:PCYC) and Janssen Biotech, Inc. Data from the Phase 2 study is being presented during the 56th Annual American Society of Hematology (ASH) meeting being held in San Francisco, CA.

Vital Therapies, Inc. (Nasdaq:VTL)
, a biotherapeutic company developing ELAD®, a cell-based therapy targeting treatment of acute liver failure, today announced enrollment of the first subject in its Phase 3 trial in severe acute alcoholic hepatitis (AAH) designated VTI-210.

Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE)
, a clinical-stage biotechnology company, today announced it was named one of the 100 Best Places to Work in PA for the fifth consecutive year.



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