BEVERLY, MA–(Marketwired – June 06, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce that the study database from the Phase 1 trial of Kevetrin (thioureidobutyronitrile) for advanced solid tumors will be “soft locked” this week. These locked results are the final protocol requirement for the study of Kevetrin in its next clinical trial and will be added to the already prepared documentation for submission to the U.S. Food and Drug Administration (“FDA”) in support of the planned Phase 1b/2 trial of Kevetrin in ovarian cancer patients with resistance to platinum-based therapies. Cellceutix is developing Kevetrin under an Orphan Drug designation from the FDA.
The first-in-human clinical trial evaluating the safety and pharmacokinetics of Kevetrin was conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The study enrolled a total of 48 patients, who had failed previous therapies, with various types of advanced solid tumors, including 11 patients with advanced ovarian cancer. A dose-escalation design was used with patients enrolled in 11 cohorts with the maximum dose administered at 750 mg/m2. Kevetrin was shown to be safe and well-tolerated, with no dose-limiting toxicities occurring among patients who received even the highest dose of Kevetrin.
Kevetrin has a unique multimodal mechanism of action. The drug enhances the activity of p53, a key tumor suppressor protein often referred to as the “Guardian Angel” gene, in both wild type and mutant p53-expressing tumors. In the majority of advanced ovarian cancer patients, p53 is inactive because of genetic mutations. In the completed trial, the hospital measured p53 activity by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. Samples were collected from patients at 7 and 24 hours after the initiation of the first Kevetrin infusion.
Preliminary data has been very encouraging. As previously released, regardless of tumor type, a total of 27 of 40 evaluable patients (67.5%) had an increase in p21 expression relative to pre-treatment levels. For patients with the greatest increases at either 7 hours or 24 hours, the mean percent increase at 7 hours (10 patients) was 38.5% (median 22%) and at 24 hours (17 patients) the mean percent increase was 24.5% (median 17%). For those patients who received Kevetrin at doses of ≤ 165 mg/m2, the mean percent increase was 21.7% (n=11). And for patients who received Kevetrin at doses ranging from 215 mg/m2 to 750 mg/m2, the mean percent increase was 35.2% (n=17). Concerning ovarian cancer in particular, analyses showed increased p21 expression in 8 of 11 (73%) patients.
The above data confirm the ability of Kevetrin to activate p53. The trial also validates the short half-life of Kevetrin in plasma. In an earlier February 2016 meeting with the FDA, the FDA agreed that a regimen of multiple doses each week is an appropriate approach. In the Phase 1 trial, patients received Kevetrin only once a week. In the planned Phase 1b/2 ovarian cancer trial, Cellceutix intends to treat patients three times weekly, with the expectation that multiple doses will enhance p53 activity and, thus, result in a corresponding improvement in therapeutic benefit. Patients will receive Kevetrin in combination with a currently approved chemotherapy (doxorubicin), as related laboratory studies produced extremely encouraging data-results that the Company hopes will continue to translate in the clinic.
“This data lock is exactly what we’ve been waiting for,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “It has been a long road, but we enrolled more patients and completed more cohorts than anyone originally expected. Underscoring this success was the strong safety profile and promising pharmacokinetic activity exhibited by Kevetrin in its first human trial. That leading scientists monitoring the study, as well as other clinical professionals both within the academic community and pharmaceutical industry, continue to want to learn more about our lead oncology drug also speaks to its potential.”
Leo Ehrlich continued: “Cellceutix certainly has diversified its pipeline over the years, but I joined this company with the intent of finding a new cancer drug after losing both my parents to the disease. Cellceutix, to date, has a perfect record of achieving success in all its clinical trials, meeting each trial’s primary endpoint. We attribute this to the rigorous study of our drugs in the laboratory setting before entering clinical trials. I’m thrilled to be moving forward with what I believe can truly become a breakthrough therapy in cancer treatment. And I am confident that by leaving the academic setting, Kevetrin’s potential in treating various cancers will be realized much more quickly.”
Cellceutix clinical trials on Clinicaltrials.gov:https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search