On May 26th, biopharmaceutical company Critical Outcome Technologies, Inc. ($COT:CA) ($COTQF) announced that they had recently been granted investigational new drug status (IND) for the Company’s small molecule activator of misfolded mutant p53 protein in gynecological cancers, a drug known as COTI-2. This IND allows Critical Outcome to continue their groundbreaking work conducting human clinical studies with COTI-2, which has shown great promise in fighting gynecological cancers (endometrial, cervical and ovarian cancers) during pre-clinical development. In June of 2014 the FDA granted orphan drug status to COTI-2 for the treatment of ovarian cancer.
“In the last twelve years, there have been no significant new treatment options for women with ovarian cancer,” says Dr. Wayne Danter, President and CEO of Critical Outcome, “so there’s a strong interest among the public and at the FDA level for new drugs to address the large unmet medical need in this area.” That means the success of COTI-2 could be a major boon for cancer patients, medical professionals, and company investors alike, as the demand could quickly create a very lucrative position for Critical Outcome.
How COTI-2 Attacks Cancer
COTI-2 is a highly novel small molecule that normalizes several mutant p53 proteins arising from the p53 gene that is commonly mutated in cancers. In fact, more than half of all cancers in humans will have at least one p53 mutation. The gene mutation then creates an abnormal protein, which brings about changes in the cell that can lead to cancer. “COTI-2 takes that abnormal protein and returns it to a more normal or wild-type structure and function,” says Dr. Danter, “essentially reversing the effect of the gene mutation in the cell.” A few ways in which COTI-2 has demonstrated its potential to treat cancers are listed below:
In preclinical trials, COTI-2 demonstrated strong in vitro and in vivo (animal) efficacy.
In in vitro testing, COTI-2 demonstrates nanomolar activity in multiple human cancer cell lines, and does not induce cross-resistance compared to certain prescribed drugs tested such as cisplatin and paclitaxel;
When used in vivo, treatment with COTI-2 I induced marked tumor growth inhibition and regression in an ovarian tumor xenograft (OVCAR-3) model without any overt toxicity in mice.
COTI-2 also negatively modulates the PI3K/AKT/mTOR pathway, which has been implicated in cancer and is involved in cell proliferation, survival, motility and morphology.
Growing Acclaim for Critical Outcome and COTI-2
Critical Outcome Technologies went public on the Toronto Exchange in 2006, and since then, they have made a name for themselves as a foremost preclinical stage drug discovery and development company. The Company’s stated goal is to prove instrumental in saving thousands of lives by enabling accelerated development of new effective treatment options – a mission that COTI-2 puts them well on the path towards achieving.
In recent months, interest in COTI-2 has been rapidly growing within the medical community. Recently, a head and neck (H&N) cancer surgeon at UT MDACC Dr. Jeff Myers noted the drug’s “striking initial results” in H&N human cancer cell lines.
Meanwhile, Dr. John Yoo, H&N cancer surgeon at Western University, Canada praised COTI-2 as the “most active drug of 1500 candidates that we have studied so far,” even asserting “that the drug needs to get to patients with recurrent HNSCC immediately”. The Company is currently planning another Phase 1 clinical trial in recurrent HNSCC for early in 2016.
What’s Next for Critical Outcome?
The next step for Critical Outcome is beginning a Phase 1 clinical trial early in the second half of 2015, which the Company will be undertaking by partnering with University of Texas, MD Anderson Cancer Center in Houston. From there, Critical Outcome is planning to develop COTI-2 through the clinic to a successful – and potentially very lucrative – licensing deal.
Perhaps even more excitingly, the team at Critical Outcomes is committed to proving they aren’t a “one-trick pony” with COTI-2, but that they have the medical knowledge, dedication and business acumen to continue innovating for years to come. “Our next goal is to develop our next molecule through the preclinical process,” says Danter. “We want to build on the success of COTI-2 by developing other promising assets in our pipeline and foster growth into the United States.”
For investors, this is undoubtedly intriguing news. After all, though the pharmaceutical sector always brings with it significant risk during the research and trial stages, once a drug has been found to be successful, there’s a possibility for truly substantial profits. COTI-2 has given Critical Outcome Technologies a marked advantage over the competition in treating p53 based cancers, and with a medical team that is focused on making significant in-roads in the oncology sector, there’s every reason to believe Critical Technologies will prove to be a leading name in the years to come.
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