Dosing expected to begin in 1Q18
HOUSTON, Jan. 08, 2018 (GLOBE NEWSWIRE) — Oncolix, Inc., (OTCQB:ONCX) announced today that the Company’s clinical site investigator has initiated patient recruitment for the second dosing group for the Prolanta™ Phase 1 clinical trial in patients with advanced ovarian cancer. Patient dosing is anticipated to begin during the first quarter of 2018. The drug supply for this dosing group is scheduled to be shipped to the clinic from the contract manufacturer during January.
“Initiating patient recruitment of the second dosing group of our first Prolanta™ clinical trial is an important milestone for the company,” said Michael T. Redman, chief executive officer of Oncolix. “Recently, we have been focused on meeting our objectives to strengthen our public company infrastructure. Now we are moving forward with our primary objective and core value driver, which is to evaluate Prolanta™ in ovarian cancer patients with the ultimate goal of demonstrating its efficacy and safety and providing it as a breakthrough treatment option to patients. We look forward to begin dosing patients during the first quarter of 2018 and to complete dosing prior to the end of the year.”
Prolanta™ is being evaluated in an open-label dose escalation Phase 1 clinical trial in patients with advanced ovarian cancer. Patients are divided into three dosing groups, or cohorts. Each sequential cohort will evaluate a higher dose of Prolanta™. Patients will be evaluated over a 99-day period. Initial dosing for 28 days is followed by a two-week safety assessment period, and then continues for an additional 56 days if no toxicities are observed. The first cohort, treated with the lowest dose, was completed, and has shown no serious adverse events or dose-limiting toxicity. For more information about the Phase 1 clinical trial please visit: https://clinicaltrials.gov/ct2/show/NCT02534922?term=Prolanta&rank=1
Oncolix is a clinical-stage biotechnology company developing Prolanta™ for the treatment of ovarian, uterine, breast and other cancers. The Company has a US FDA-cleared IND to commence human testing of Prolanta™ in its first indication, the treatment of ovarian cancer. This Phase 1 clinical trial is currently in progress. Prolanta™ is a prolactin receptor antagonist (or blocker) that has demonstrated efficacy in xenograft models through a unique mechanism of action, autophagy. In addition to ovarian cancer, there is strong preclinical evidence Prolanta™ may be effective in breast, prostate and other cancers. In the current Phase 1 dose-escalation safety trial for the treatment of ovarian cancer, to date there have been no observed serious adverse events and no dose-limiting toxicities. The FDA has approved the designation of Prolanta™ as an Orphan Drug for the treatment of ovarian cancer, which may result in reduced filing fees (currently $2 million), federal tax credits and marketing exclusivity.
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