|CEL-SCI Authorizes Expansion of Phase III Clinical Trial to an Additional 4 European Countries; Repros Receives Official FDA Minutes From Type C Meeting for Androxal(R)|
|By Staff and Wire Reports|
|Tuesday, 27 December 2011 18:00|
CEL-SCI Corporation (NYSE:CVM) is in the process of expanding its Phase III clinical trial of the investigational therapy Multikine (Leukocyte Interleukin, Injection)* to 4 additional European countries - Spain, Czech Republic, Slovakia and Croatia. These four countries were selected because they have not only the required facilities and well trained scientific and technical personnel with the experience necessary for running this Phase III study, but also because they have a high incidence of head and neck cancer. CEL-SCIs partner, Teva Pharmaceuticals Industries, who has the marketing rights to Croatia has selected 2-3 clinical centers in Croatia that have the capability and interest in conducting this study. The Multikine Phase III study is currently being run in 8 countries, including the US, on 3 continents.
"We are encouraged by recent observations from the study and therefore feel that all resources should be put into getting this study completed as quickly as possible to definitively establish Multikines effectiveness. That is why we are adding as many as 15 clinical centers in these 4 countries, said Geert Kersten, CEL-SCI's Chief Executive Officer.
CEL-SCIs Phase III study is designed to determine if Multikine (Leukocyte Interleukin, Injection) investigational therapy administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for the treatment naive (yet untreated) subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only.
Repros Therapeutics Inc. (RPRX) ® (Nasdaq:RPRX) announced the Company has received the official FDA minutes from its recent Type C meeting held with the joint divisions of urologic (DRUP) and endocrinologic (DMEP) products. The Company believes the meeting and minutes will help it set the path forward for Androxal. As part of the request for the meeting, Repros asked three questions. The first two dealt with whether or not either the Endocrine or Urology Division would allow the normalization of testicular testosterone synthesis as the only primary endpoint needed for approval. In the third question Repros asked if it was appropriate for both divisions to review the dossier.
Both divisions concurred that a clinically meaningful outcome other than testosterone would be required for approval, and if the drug were to be reviewed in the Endocrine Division, metabolic outcomes would be required as for any other drug intended to improve glycemic indices.
In the meeting minutes the FDA noted, "DRUP reminded the Sponsor of the pathway provided at prior meetings for the treatment of hypogonadism while preserving semen quality." The minutes further state, "The Sponsor agreed to proceed with a path forward within DRUP. The Sponsor stated that they have data from some of their completed studies and will submit it to DRUP for review. The Sponsor also stated that they are planning to submit a Type B meeting request early next year."
Joseph S. Podolski, President and CEO of Repros Therapeutics, commented, "We are appreciative of the FDA's efforts and willingness to allow the joint meeting. We understand their position and we look forward to submitting the final clinical study reports for ZA-203 and ZA-204 to the Division of Reproductive and Urologic Products (DRUP) late in February to support a Type B meeting in March or April with the goal of reaching agreement for the Androxal Phase 3 study design."
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