Oncolix Initiates Patient Recruitment of Second Cohort of Prolanta™ Phase 1 Trial in Advanced Ovarian Cancer
January 08 2018 - 7:00AM
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,”
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Forward-looking statements relate to anticipated or expected
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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