GERMANTOWN, Md.--(BUSINESS WIRE)--Amarex today announced its work on behalf of Gibson Oncology has resulted in an Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) for the drug LMP744.
LMP744 treats gliomas, readily crossing the blood brain barrier (BBB) at 10 times the concentration required to kill cancer cells and sustains a high concentration for over 24 hours per dose.
“For decades glioblastoma brain cancer patients have not seen appreciable increases in overall survival rates with Temodar, the current standard of care treatment,” said Mr. Randall Riggs, President & CEO of Gibson Oncology. “Our goal is to advance both LMP400 and LMP744 to market via the shortest and quickest path, thus benefiting cancer patients in need.”
Obtaining ODD for LMP744 for all gliomas underscores the promising and novel treatment of the drug to inhibit two cancer targets: TOPO 1 and downregulate cMyc overexpression through the drug’s potent binding of the G4 quadruplex of cMyc.
“This crucial designation could not come at a more critical time for the families who are fighting this disease,” said Dr. Kush Dhody, President, Amarex. “Reaching this milestone sets the company up for future success and, most importantly, poises Gibson Oncology to continue its path to commercialization of this life-saving treatment.”
Through a multi-year collaboration with cMyc expert, Dr. Danzhou Yang of Purdue University, Gibson Oncology discovered that LMP400, which received ODD earlier in the year, and LMP744 are potent nM inhibitors of both TOPO 1 and cMyc oncogene. Together, the teams determined that LMP744, a small molecule, selectively targets two well-known drivers of human cancers, cMyc oncogene and TOPO 1.
The discovery of this compound’s unique anti-cancer mechanism of action (MOA) allowed Gibson Oncology to better position LMP744 and LMP400 to cancer targets with high unmet medical needs.
Presently, LMP744 and LMP400 is positioned to enter a Phase 2 human clinical trial in recurrent gliomas in collaboration with the National Institutes of Health (NIH).
Gibson Oncology believes it is important to leverage the Orphan Drug Designation both drugs have received from the FDA for all gliomas, not just glioblastomas, which includes children with gliomas. Rapid regulatory advancement empowers LMP400 and LMP744 to the shortest and quickest path to market, thus benefiting cancer patients in need.
About Gibson Pharmaceuticals
Gibson Oncology is a private biotechnology company with a unique portfolio of five small molecules for cancer therapy discovered at the National Cancer Institute and Purdue University. These agents have both TOPO 1 as well as cMyc activity and already have had five clinical trials completely supported by the NCI in recurrent solid tumors and lymphomas. Our lead agent, LMP744, is currently positioned for a Phase 2 trial in first recurrent glioblastoma patients, and LMP400 in first recurrent glioma patients with PTEN deficiency.
Gibson has a second generation of newly invented and patented drugs, also showing combined TOPO 1 and cMyc activity known as the 7-Azaindenoisoquinolines (the AZAs). Discovered by Dr. Mark Cushman at Purdue University and exclusively licensed to Gibson, these agents also show TOPO 1 effects not by traditional camptothecin mechanisms found in older drugs like Irinotecan and Topotecan. Gibson has demonstrated that the AZAs work on cMyc inhibition epigenetically through the G-quadruplex.
About Amarex Clinical Research, LLC
Amarex Clinical Research, LLC, is a global, full-service Contract Research Organization (CRO) with significant expertise conducting clinical research. The leadership team’s combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information visit www.amarexcro.com.
