|CEL-SCI Expands Its Pivotal Phase III Immunotherapy Cancer Trial; Karyopharm to Present Clinical Data Update for Selinexor (KPT-330)|
|By Josh Gee|
|Monday, 08 December 2014 19:43|
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.
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."
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