By: Tomas Ronolski - AllPennyStocks.com News

Wednesday, December 2, 2015

In oncology, scientists have been trying to safely reach and normalize the p53 protein pathway for decades. It is well known that p53 plays a pivotal role in tumor suppression, however, p53 is commonly damaged in cancer patients, preventing it from performing its duty as a master cell cycle regulator. It is this protector role that has earned the gene the nickname the “Guardian Angel of the Human Genome.” The problem is that the p53 pathway is failing through one fashion or another (i.e. mutation, under-expression, etc.) in 42 percent of common cancers, more than 50 percent of pancreatic cancers and 70 percent of lung cancers. Understanding is one thing, but successfully repairing p53 without toxicity has proven to be a grand challenge for scientists. Research seems to be trending in the right direction. Scientists from Trinity College Dublin recently discovered that the protein PCL1 binds to and amplifies the function of p53, presenting the possibility of utilizing the dynamic duo in future research to roust cancer stem cells out of quiescence so they can be targeted.

In other studies, a team led by researchers at The University of Texas MD Anderson Cancer Center showed the specific interaction between p53, the micro RNA miR-34a and the protein PDL1. More succinctly, the team demonstrated that loss of p53 function can lead to overexpression of PDL1, which associates with tumor aggressiveness.

Cellceutix Corp.’s (OTCPK:CTIX) novel small molecule, Kevetrin, has been shown to induce activation of p53 as measured by the downstream biomarker p21. A phase 1 clinical trial of Kevetrin for advanced solid tumors being hosted at Harvard Cancer Center’s Dana-Farber Cancer Institute is near complete, positioning the company near the head of the class in the p53 drug development space. The U.S. Food and Drug Administration has awarded Cellceutix an Orphan Drug designation and Pediatric Rare Disease designation for Kevetrin for the treatment of retinoblastoma and an Orphan Drug designation for Kevetrin for ovarian cancer.

The FDA Orphan Drug program is meant to expedite development of drugs that demonstrate promise for treating rare diseases and conditions, defined as affecting fewer than 200,000 people in the U.S. In addition to potential access to other expedited developmental initiatives and benefits, a product that reaches market under an Orphan Drug designation is entitled to a seven-year exclusive marketing period in the U.S. for the specified indication.

London, Ontario-based Critical Outcome Technologies, Inc. (TSX-Venture:COT) (OTCQB:COTQF) is lining up to take its lead cancer drug candidate, COTI-2, into the clinic to evaluate its ability to change mutant p53 to wild-type-like p53 conformation to promote cell death (apoptosis). Critical Outcome Technologies is developing COTI-2, a third generation thiosemicarbazone, as an oral treatment for solid tumors and looking to validate pre-clinical studies that show the compound can restore mutant p53 function across an array of human cancers, including small cell lung, non-small cell lung, colon, brain, ovarian and pancreatic, to name a few. The company discovered COTI-2 using CHEMSAS, a proprietary drug discovery engine that uses artificial intelligence algorithms.

Critical Outcome Technologies plans to study COTI-2 in the U.S. with MD Anderson Cancer Center for the treatment of gynecological cancers and in Canada with Western University for treating patients with recurrent head and neck squamous cell cancer. The FDA awarded the company an Orphan Drug designation for COTI-2 for ovarian cancer in May 2014. Late in May this year, the U.S. FDA granted investigational new drug (IND) status paving the way for the gynecological trial. COTI had said on Wednesday that it expects the trial to begin in “mid-December.”

COTI also said that it is going after Orphan Drug designation for COTI-2 for the treatment of Li-Fraumeni Syndrome (LFS) and has submitted the requisite application to the FDA. LFS is a rare disorder that greatly increases the risk of developing several types of cancer, particularly in children and young adults.

"We believe that COTI-2's impact on cancer treatment will be far-reaching," said Dr. Wayne Danter, President and CEO at Critical Outcome Technologies. "As we have noted in the past, we are pursuing multiple cancer indications with our lead asset, COTI-2. The prevalence of p53 gene mutations among people with LFS makes this a highly relevant target for COTI-2 and its unique mechanism of action,” he added.

Toronto-listed shares of COT were flat following the news at 27 cents on roughly 76,000 in volume as the day winds towards the closing bell. US-listed shares were even at 20.7 cents, with only 7,000 shares changing hands.

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