PharmacoFore, Inc. Announces Positive Results from a Phase I Clinical Study of Its Hydromorphone Bio-Activated Molecular Delivery™ System, and Upcoming Presentation at the 2011 Biotechnology Industry Organization (BIO) Business Forum During the Annual Bio
Published: Jun 24, 2011
SAN CARLOS, Calif., June 23, 2011 /PRNewswire/ -- PharmacoFore, Inc., a privately held biopharmaceutical company developing next-generation abuse-resistant prescription drugs, today announced positive results from a Phase I human proof-of-concept (hPOC) study of its hydromorphone (HM) Bio-Activated Molecular Delivery (Bio-MD) product candidate, PF329. Greg Sturmer, VP, Finance and CFO, will present at the 2011 BIO Business Forum during the annual BIO International Convention at the Walter E. Washington Convention Center in Washington, D.C. Mr. Sturmer's presentation will be given on Thursday, June 30, 2011, at 10:00 a.m. EDT in the Georgetown Room. The presentation will include an overview of the company's Bio-MD and Multi-Pill Abuse-Resistance (MPAR)technologies and pipeline.
The Bio-MD technology is designed to release clinically effective opioid drug only when exposed to the correct physiologic conditions (i.e., when orally ingested). The result is activation and controlled release of an opioid drug in the gastrointestinal tract, which is then absorbed normally into the patient's blood stream. This approach achieves two important goals: (i) greatly reducing the opportunities for abuse of opioid drugs, and (ii) maintaining, unaltered, the opioid's potent analgesic effects in a safe manner.
The Phase 1 hPOC study demonstrated that PF329 is safe and releases HM in a dose-proportional manner and that the process of delivery is efficient. Time to maximal plasma concentration of HM following administration of PF329 is approximately two hours, slower than immediate release HM and more rapid than the published data for the commercial, once-per-day HM product, Exalgo®. By delivering PF329 in solution in this study, PharmacoFore demonstrated that the extended release profile is intrinsic to the molecule; that is, the Bio-MD technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. PF329's pharmacokinetic profile appears optimal for twice-daily dosing.
The Phase I study was a single-center, dose-escalation and fixed-dose crossover, cohort study to determine the safety and pharmacokinetics of a single oral dose of PF329 in healthy subjects. Fifty-one healthy volunteers received oral doses of PF329 in solution ranging from 1 48 mg, and 12 received immediate release HM in approximately molar-equivalent doses. The objectives of the study were to assess the safety, tolerability, and pharmacokinetics of PF329, as well as the pharmacokinetics of its pharmaceutically active moiety, HM. The secondary objectives of the study were to identify appropriate doses of PF329 for subsequent clinical studies and to evaluate the effects of food on the pharmacokinetics of PF329. HM exposures were independent of the fed / fasted state of the subjects.
Dr. Lynn Webster, a world leader in pain management and prescription drug abuse, explained, "PharmacoFore's Bio-MD system not only resists abuse via injection and inhalation, but, importantly, the most common method, which is oral abuse. As the Phase 1 study demonstrates, crushing or chewing will not affect the extended release profile of the delivery system. Further, unlike any other product on the market or in development, combining the Bio-MD and MPAR technologies will remove the incentive to abuse by consuming multiple pills, and protect against oral overdose."
According to Steven Passik, PhD, Professor of Psychiatry and Anesthesiology, Vanderbilt University Medical Center, "New and innovative abuse-deterrent technologies are greatly needed in our efforts to continue to treat pain and take reasonable and responsible steps to prevent abuse and diversion."
"We believe these data provide objective evidence of the viability of the Bio-MD platform," said Dr. Wes Sterman, PharmacoFore's President and CEO. "The success of this clinical study supports advancing a number of additional therapeutically important products into the clinic."
About PharmacoFore, Inc.
PharmacoFore, Inc., is a privately held biopharmaceutical company focused on creating novel medicines to improve upon the therapeutic utility of existing drugs, enhance patient care, and prevent the misuse, abuse, and overdose of prescription medications. The Company's novel Bio-Activated Molecular Delivery system (Bio-MDs), in contrast to current approaches, effectively addresses abuse via injection and inhalation, as well as abuse via the more common oral route (e.g., chewing pills prior to ingestion).
PharmacoFore has also created a complementary technology, uniquely applicable to drugs with its Bio-MDs' mechanism of activation, which provides multi-pill abuse-resistance (MPAR) that is, oral overdose protection. When several doses of MPAR-protected drugs are co-ingested, the systemic exposure of the opioid drug is dramatically limited. Ultimately, PharmacoFore's technology will (1) provide patients with the best treatment option for moderate-to-severe pain; (2) address the worldwide under-treatment of pain; (3) offer a comprehensive solution to the rapidly growing global issue of prescription drug abuse, and; (4) for the first time, provide protection against oral routes of abuse.
About Prescription Drug Abuse
Pain affects more Americans than diabetes, heart disease, and cancer combined, with chronic pain being the most common cause of long-term disability according to the U.S. National Institutes of Health. The U.S. economic impact of acute and chronic pain exceeds $100 billion per year.
Prescription drug abuse and addiction are major burdens to American society, resulting in significant costs, illness and deaths. More than 48 million Americans abuse prescription drugs in their lifetimes; in 2005, such abuse cost the government $467.7 billion.
Forward Looking Statements and Information
This press release contains forward-looking statements regarding, among other things, statements relating to expectations, goals, plans, objectives and future events. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause actual results to differ materially from those indicated by forward-looking statements. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
PharmacoFore, Inc. Contact:
A. Gregory Sturmer
VP, Finance and Chief Financial Officer
Tiberend Strategic Advisors, Inc.
SOURCE PharmacoFore, Inc.