ROCKVILLE, Md.--(BUSINESS WIRE)--Precision Biologics is pleased to announce promising overall survival (OS) data from its ongoing Phase 2 study using its novel monoclonal antibody NPC-1C in patients with metastatic colorectal cancer who have exhausted all standard therapies. The data will be presented by Dr. Muhammad Beg from the University of Texas Southwestern (UTSW) Medical Center as well as investigators from Duke University and Johns Hopkins Hospital at the ASCO GI Symposium on January 16, 2015 in San Francisco, CA.
Thirty patients have enrolled thus far with treatment refractory metastatic colorectal cancer. Median Overall Survival (OS) is currently 10.2 months. This compares favorably to the Regorafenib Phase 3 study which showed OS of 5.0 months in the historical control group and 6.4 months OS for patients receiving Regorafenib.
In addition, at the maximum tolerated dose (MTD), NPC-1C (3.0 mg/kg IV every 2 weeks) is very well tolerated compared to the significantly more toxic Regorafenib regimen.
According to the Principal Investigator, Dr. Muhammad Beg at UTSW, “the ongoing data from NPC-1C demonstrates encouraging signs in this very difficult to treat population of patients; in addition, the drug has an excellent safety profile.”
This Phase 2 Study will treat a total of 43 patients with colorectal cancer at the MTD to establish superior OS compared to current available therapies.
Presentation Information: General Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract, Board A11.
Abstract Title: A phase I/II multicenter study of the chimeric monoclonal antibody NEO102 (NPC-1C) in adults with refractory pancreatic (PC) and colorectal cancer (CC).
In addition, Dr. Austin Duffy from the National Cancer Institute will be presenting at the Trials in Progress Poster Session on January 16th. He will present a multicenter randomized phase II study of gemcitabine and nab-paclitaxel with or without NPC-1C in patients with metastatic or locally advanced pancreatic cancer previously treated with FOLFIRINOX .(Abstract TPS499).
Detailed descriptions of these studies can be found at the following link from ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/results?term=NPC-1C&Search=Search
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Precision Biologics
Founded in February 2012 and commencing business in late September 2012, Precision Biologics, Inc. is a clinical stage biotechnology corporation focused on developing therapeutic and diagnostic products for the early detection and treatment of cancer. Precision Biologics is uniquely positioned to create innovative therapeutics through the use of proprietary cancer vaccines, several of which have demonstrated success in human trials.
Contacts
Press:
Sophia Lall, 212-414-1909
Cell: 718-483-0735
slall@rmtprmanagement.com
or
RoseMarie Terenzio, 212-414-1909
Cell: 917-913-7226
rterenzio@rmtprmanagement.com
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