SAN JOSE, Calif., Oct. 24, 2018 /PRNewswire/ -- Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body's immune system to fight cancer, today announced that a Pre-Submission (Pre-Sub) meeting with the US FDA has been scheduled on Monday, December 17, 2018. The meeting is to discuss the proposed preclinical and clinical performance testing plan required to support a pre-market application, and to determine the appropriate regulatory pathway for the Cchek™ prostate cancer confirmation test.
The purpose of a Pre-Sub meeting is to permit a dialogue between the FDA and a diagnostic developer to facilitate a better understanding of the regulatory path enabling commercialization. With the Pre-Sub request, Anixa presented to the FDA a clinical trial plan and a group of questions on which it would like comment and clarification. After the meeting, and receipt of official minutes from the meeting, Anixa expects to have a better understanding of the regulatory pathway and anticipated timeline for commercialization.
"We are pleased that we were able to get our meeting with the FDA scheduled before the end of the year. We are looking forward to a productive discussion with the FDA that will help clarify the commercialization pathway for Cchek™ as a prostate cancer diagnostic test. I want to make clear that this new dialogue with the FDA is independent of and in addition to the dialogue we have already started regarding our CAR-T therapy. Both programs and corresponding interactions with the FDA will move forward independently at their own pace," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "For Anixa Biosciences, this is an exciting time as we now have two technologies and products, regarding which we are working with regulators."
About Anixa Biosciences, Inc. Anixa, a cancer-focused biotechnology company, is harnessing the body's immune system in the fight against cancer. Anixa is developing both diagnostics and therapeutics to detect cancer early, when it is most curable, and to treat those afflicted once diagnosed. It is developing the CchekTM platform, a series of inexpensive non-invasive blood tests for the early detection of solid tumors, which is based on the body's immune response to the presence of a malignancy. It is also developing chimeric antigen receptor T-cell (CAR-T) based immuno-therapy drugs which genetically engineer a patient's own immune cells to fight cancer. Anixa also continually examines emerging technologies in complementary or related fields for further development and commercialization. Additional information is available at www.anixa.com.
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