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news.Critical Outcome Technologies, the bioinformatics and accelerated drug discovery company, is pleased to announce that it has signed a letter of intent ("LOI") with The University of Texas MD Anderson Cancer Center in Houston ("MD Anderson"), for the Phase 1 clinical development of the Company's lead cancer drug candidate, COTI-2, in gynecological cancers.
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"COTI-2 is selectively active in in vivo and in vitro models with abnormal TP53. This is very exciting as TP53 is one of the "big three" of critically important genes that are not directly targetable. Further, TP53 is almost universally abnormal in high-grade serous ovarian cancer, the most common and most aggressive ovarian cancer. Thus the opportunity to test COTI-2 in ovarian cancer is both timely and exciting," said Dr. Gordon Mills Chair of Systems Biology and co-head of the Women’s Cancer Moonshot Program.
Dr. Shannon Westin, Assistant Professor in Gynecologic Oncology and co-principal investigator for the COTI-2 clinical trial, noted, "We have been eagerly anticipating the opportunity to target this common molecular aberration. COTI-2 has the potential to make a huge impact on the clinical care of women with advanced and recurrent gynecologic malignancies."
"We are looking forward to this partnership with MD Anderson and believe the collaboration will result in COTI-2 one day becoming a breakthrough therapy not only for ovarian cancer patients, but for many patients with other common cancers," said Dr. Wayne Danter, COTI’s Chief Executive Officer.
"MD Anderson ranks as one of the world’s most respected cancer centers focused on patient care, research, education, and prevention. It has the state-of-the-art facilities, technical capabilities, and expertise to successfully execute the clinical development of COTI-2. Dr. Mills and his team at MD Anderson have been conducting experiments with COTI-2 for the past 21 months and are now very familiar with its mechanism of action and we believe are in the best position to partner with us as we move the compound forward into clinical trials."
Under the terms of the proposed agreement, the Company and MD Anderson will work together to design and conduct a first in humans (Phase 1) study with oral COTI-2 in up to 40 women with advanced gynecological cancers who have failed conventional therapy.
For the purposes of the study, the term "gynecological" cancers refers to cancers of the ovary, endometrium, and cervix. The parties have negotiated a cost structure for the clinical trial that is very favorable to the Company. COTI’s contribution is estimated at approximately $1.25 million USD with the remainder of the costs provided by MD Anderson as in kind monitoring, testing, and pharmacy capabilities.
The parties anticipate that patient recruitment for the Phase 1 clinical trial will begin in early 2015. The co-principal investigators for the COTI-2 Phase 1 clinical trial will be Dr. Gordon B. Mills, Chairman, Department of Systems Biology, Wiess Distinguished University Chair in Cancer Medicine, Co-Director, Institute for Personalized Cancer Therapy at MD Anderson and Dr. Shannon Westin, MD, MPH Assistant Professor, Department of Gynecologic Oncology and Reproductive Medicine at MD Anderson.
Additional details will be communicated when the definitive agreement has been completed.