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
About Oncolix
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.
Forward-Looking Statements
This press release above may contain forward‐looking statements about the business, financial condition and prospects of the Company. Forward looking statements can be identified by the use of forward-looking terminology such as “believes,” “projects,” “expects,” “may,” “goal,” “estimates,” “should,” “plans,” “targets,” “intends,” “could,” or “anticipates,” or the negative thereof, or other variations thereon, or comparable terminology, by discussions of strategy or objectives. Forward-looking statements relate to anticipated or expected events, activities, trends or results. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties.
Although the Company believes that the expectations reflected in forward-looking statements are reasonable, there can be no assurances that such expectations will prove to be accurate. Security holders are cautioned that such forward-looking statements involve risks and uncertainties. The forward-looking statements contained in the press release speak only as of the date of the press release, and the Company expressly disclaims any obligation or undertaking to report any updates or revisions to any such statement to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such statement is based. Certain factors may cause results to differ materially from those anticipated by some of the statements made in the press release. Investors are urged to consider closely the disclosures in our Forms 10-K, 10-Q, 8-K and other filings with the SEC, which can be electronically accessed from the SEC's website at http://www.sec.gov/.
Corporate contact:
Michael Redman
P: 281-402-3167
E: mredman@oncolixbio.com
Investor contact:
The Ruth Group
Robert Flamm, Ph.D. / Kristin Ko, Ph.D.
P: 646-536-7017 / 7036
E: rflamm@theruthgroup.com / kko@theruthgroup.com