HOUSTON, TX / ACCESSWIRE / July 17, 2018 / Oncolix, Inc. (OTCQB: ONCX) (the "Company"), a biotechnology company focused on gynecological cancers, announced that the Company has appointed Robert Niecestro, PhD as its first member of its Regulatory Strategy, Scientific and Clinical Advisory Board.
"Dr. Niecestro is a valuable resource to Oncolix because we want to properly navigate Prolanta and new acquisitions through the worldwide regulatory processes, especially the Food and Drug Administration (FDA)," said Michael T. Redman, president and chief executive officer of Oncolix. "His experience in both clinical and regulatory development will be an outstanding asset to Oncolix."
Dr. Niecestro currently serves as the Vice President, Clinical and Regulatory of Axsome Therapeutics since October 2012 as a consultant. He assisted the founder of Axsome Therapeutics in developing a clinical-regulatory development pathway that has resulted in Phase 3 clinical trials in different CNS therapeutic areas, which include Special Protocol Assessments (SPA) granted by the FDA. Dr. Niecestro also serves on the Board of Directors for the Collaborative Study Group (an academic research group in nephrology based at Vanderbilt University) since 2014 as a regulatory advisor. Dr. Niecestro currently consults with Auris Medical, Avenue Therapeutics, Citius Pharmaceuticals, Cyprium Therapeutics, and RDD Pharma.
Dr. Niecestro served as the Executive Vice President of Clinical and Regulatory Affairs for TG Therapeutics from 2012 to February 2018 and played a pivotal role in negotiating the nonclinical and clinical development program for the combination of two experimental oncology agents, ublituximab (TG-1101) and umbralisib (TGR-1202) with the FDA and EMA with some of the Phase 3 clinical trials being conducted under a Special Protocol Assessment (SPA) granted by the FDA. Dr. Niecestro also assisted Checkpoint Therapeutics in the filing of their first IND for CK-101 (EGFR inhibitor) and the in-license of other drugs now in their pipeline. Previously, Dr. Niecestro served as the Vice President of Regulatory Affairs for Keryx Biopharmaceuticals from 2004 to 2012 and was responsible for the NDA filing of Auryxia® (ferric citrate) as a phosphate binder and developed the clinical program for Auryxia as an iron replacement therapy. Dr. Niecestro held numerous senior management positions in the pharmaceutical industry serving as the Vice President of Clinical Development for Andrx Laboratories; Senior Director, Clinical Development and Therapeutic Head for Gastrointestinal, Oncology and Stroke at Eisai Inc.; and Director, Clinical Operations and NDA Planning for Organon Inc. Dr. Niecestro has been involved in the filing of over 60 INDs; approval of 13 NDAs or BLAs (new drugs in the United States); has over 60 peer-reviewed scientific presentations, abstract and/or publications, and holds 3 patents. Dr. Niecestro completed his graduate and post-graduate work at the University of Illinois at Chicago.
"Prolanta has the potential to be effective in a number of gynecological cancers, said Dr. Niecestro. It is paramount we prioritize these potential disease indications so that we can effectively pursue the cancers with the highest unmet medical needs coupled with the strongest Prolanta preclinical efficacy data."
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.
Corporate contact:
Michael Redman
P: 281-402-3167
E: mredman@oncolixbio.com
SOURCE: Oncolix, Inc.
