POTOMAC, Md.--(BUSINESS WIRE)--PreScience Labs, LLC (“PreScience”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved its Investigational New Drug (“IND”) application for Phase I clinical evaluation of its anti-cancer drug 3-bromopyruvate (“3-BrPA” or “PSL-001”). This Phase I clinical trial will be conducted in patients with primary and/or metastatic liver cancer.
Earlier this year, the FDA informed PreScience that it may commence immediate enrollment of human subjects into its much anticipated Phase I clinical trial evaluating its lead drug candidate, PSL-001, delivered intra-arterially into the liver. Over many years of research, this drug has shown extraordinary efficacy in both multiple cancer cell lines and numerous animal tumor models. Preclinical studies in various tumor types have demonstrated that this potent drug is not only extremely effective but also very well tolerated. These results have been reported in many published manuscripts and presented throughout the world at medical conferences. The planned Phase I study will evaluate the dosing regimen of the drug to determine the maximum tolerated dose (“MTD”) based on the safety data. This will allow PreScience to prepare for a Phase II study which will specifically study drug efficacy.
Commenting on the IND acceptance, Dr. Jeff Geschwind, Founder and CEO of PreScience, stated, “It is extremely gratifying to have seen the development of this compound from the bench to the clinic in a relatively short time. I am highly optimistic that this drug will prove as effective in patients suffering from cancer as it was for the animals. This would be a tremendous breakthrough for cancer patients.”
This will be the first formal evaluation in the world of this compound. PreScience plans to enroll patients in its Phase I study at leading medical centers in the U.S. It anticipates that the first patient will be enrolled in early-2014.
About PreScience Labs, LLC:
PreScience is a developmental stage bio-pharmaceutical company focused on the development of anti-cancer drugs. It has successfully completed preclinical mechanistic, in vitro and animal testing using intra-arterial delivery of its proprietary drug PSL-001. The FDA approved immediate enrollment of a Phase I, dose-escalating study, which PreScience intends to initiate at leading US cancer centers in 2014. The study will recruit primary and metastatic liver cancer patients. Additional information can be found at www.presciencelabs.com
PSL-001 is part of a patent portfolio fully and exclusively licensed from Johns Hopkins University by PreScience. PSL-001 is one of a new class of drugs that targets the tumor glycolysis pathway. This pathway is a signature of cancer cells and is considered one of the hallmarks of cancer. Tumor glycolysis has been exploited for diagnostic purposes (PET imaging) and is now being explored for therapeutic intervention. One of the key enzymes in tumor glycolysis, GAPDH, is the primary target of PSL-001. PSL-001 irreversibly binds to GAPDH resulting in a multi-prong assault on cancer cells, ultimately leading to their death. The predominant effect of this interaction is the profound depletion of ATP, depriving the cancer cells of any energy. Because glycolysis is the dominant metabolic pathway in cancer cells, those cells are acutely sensitive to any disruption of that pathway. In addition, because normal cells do not rely on glycolysis, but rather on oxidative phosphorylation for their energy needs, disruption of glycolysis is highly specific to cancer cells. The combination of high sensitivity and specificity makes targeting tumor glycolysis highly attractive. Through its ability to inhibit GAPDH, PSL-001 has proven extremely effective at shutting down the energy-producing capabilities of cancer cells which in turn destroys them. PreScience’s core technology and patent protection relies on both the novel PSL-001 compound and the targeted regional delivery of the drug, thereby treating only the cancer. PSL-001 will be further evaluated in a PreScience sponsored Phase I study to begin enrollment in early-2014.