BioCorRx Selects Covance for Non-Clinical Studies, Announces the Addition of Dr. Bal S. Brar to its Drug Development Team, Plans Pre-IND Meeting with FDA
ANAHEIM, CA, Nov. 28, 2016 (GLOBE NEWSWIRE) -- BioCorRx Inc. (OTC PINK: BICX) (the "Company"), a developer and provider of advanced solutions in the treatment of alcohol and opioid addictions, announces several operational developments as well as provides a strategic initiative update:
- BioCorRx has announced that it has selected Covance, Inc. as the Contract Research Organization (CRO) for non-clinical studies of its new injectable naltrexone formulation, BICX101, being developed under its BioCorRx Pharmaceuticals subsidiary.
- Covance, Inc. is scheduled to initiate first-study on December 22, 2016; and expects completion of first-study within 4-5 weeks from start date.
- BioCorRx is planning the request for a pre-IND meeting with the FDA and anticipates a meeting date sometime in Q1 2017.
- Dr. Balbir S. Brar has joined BioCorRx as a lead drug development study design consultant for the subsidiary.
BioCorRx Engages Covance, Inc. as its CRO:
Covance, Inc. is an international CRO with headquarters in Princeton, New Jersey, and provides drug development and testing services. The purpose of the studies with Covance is to help determine the optimal dose strength of BioCorRx’s proprietary lead-candidate formulation. BioCorRx’s once-a-month injectable naltrexone is being developed in partnership with TheraKine, Ltd. through an agreement announced earlier this year in which BioCorRx will retain worldwide rights to the new formulation for the treatment of addiction using TheraKine’s underlying patented delivery technology.
Naltrexone is a non-addictive opioid antagonist that has already been approved by the FDA in other forms for the treatment of alcohol and opioid dependence. It can reduce or eliminate cravings for alcohol and opioids as well as block dangerous effects of opioid use such as overdose (commonly seen in heroin use). BioCorRx seeks to approve a more efficient delivery of naltrexone with the prospect of better patient adherence to monthly injections; as well as easier administration of the injection by healthcare providers.
BioCorRx Announces First-Study Initiation:
The first study designed to select the extended release lead-formulation for clinical development is scheduled to commence on December 22, 2016 at Covance’s United Kingdom facility. Covance’s initial first-study efforts are slated to last approximately 4-5 weeks. BioCorRx expects to receive initial data after 14 days of treatment and then subsequently after 28-35 days.
If ultimately successful, BioCorRx’s lead-formulation is expected to last over 30 days with serum naltrexone levels at or above 2 ng/ml; which has been proven to be effective in craving-reduction of alcohol and opioids as well as in protecting opioid users from overdose if they attempt to use while an adequate level of naltrexone is in their system. BioCorRx is planning the request of a pre-IND meeting with the FDA and anticipates a meeting date sometime in Q1 2017 to present the data from the in vitro release and in vivo absorption studies. The Company is expecting to gain FDA approval on BICX101 via a 505(b)(2) application, which is considered “fast tracking” from a regulatory pathway standpoint and provides several cost and time to market benefits. This regulatory pathway is potentially available to BioCorRx in that naltrexone has been approved by the FDA in other delivery forms several times since 1985.
BioCorRx Announces Addition of Dr. Bal S Brar to Drug Development Team:
BioCorRx is also pleased to announce that Dr. Balbir S. Brar has joined the Company as a lead drug development study design consultant under the BioCorRx Pharmaceuticals subsidiary. Dr. Brar has over 25 years of experience for drug and device development. Dr. Brar also has worldwide regulatory submission of 50 IND's/510K's and 505(b)(2)’s; and approval of 8 NDA's. Among prior successful NDA efforts in which Dr. Brar was involved, several ultimately became successful drugs currently on the market. Dr. Brar’s experiences include working with major pharmaceutical companies – Lederle /Wyeth, GlaxoSmithKline, Allergan – where he was participatory to several successful development efforts. At Azmacort Dr. Brar participated in development efforts for asthma and topical Aristocort . At GlaxoSmithKline, as Senior Director of Drug Safety, Dr. Brar participated in the development of Tazarotene. At Allergan, as Vice President Drug Safety, Dr. Brar made major contributions towards regulatory submission and approval of Botox, Alphagan, Lumigan, Restasis, Ofloxacin, Azelex, and Avage.
For the past 10 years Dr. Brar has played a leadership role within several early stage biotechnology companies. Dr. Brar has served on the Board of Directors for multiple companies, acted as President, EVP R&D, and Chief Technology Officer; and held positions in the fields of Nephropathy, Oncology, Ophthalmology, Dermatology, and Pain and Cardiovascular. His responsibilities have included participation in capital raising, selection of CRO's for GMP chemical synthesis of API, formulation Drug Product development, manufacture of clinical/non-clinical supplies, stability testing, non-clinical studies, clinical studies, Phase I, II, and III, IND and 505(b)(2) filings for companies. Additionally, Dr. Brar brings with him a deep bench of strong contacts with CRO's and experience in working with FDA and regulatory agencies worldwide.
Dr. Brar has a Ph.D. in Toxicology/Pathology from Rutgers University and D.V.M. from India with finance training from Harvard Business School. Dr.Brar is a recipient of numerous achievements awards for excellence and belongs to a number of scientific organizations. Dr. Bra is also the author/coauthor of over 55 scientific publications.
Brady Granier, President, CEO and Director stated, “We are very excited to move into this next stage of our new injectable formulation and very pleased to have selected Covance to conduct the extended release and absorption studies for BICX101. Covance is a top notch CRO and came highly recommended by our team of advisors. We look forward to completing the studies very early in 2017 and towards presentation of data to the FDA in the pre-IND meeting. From what we have seen in the in vitro release lab studies thus far, we are very confident that we will have a very effective product to help fight this opioid epidemic and alcoholism problem. We are also ecstatic to have someone of the caliber of Dr. Brar on the team to help guide us through the development and regulatory pathway. Dr. Brar’s wisdom and experience are invaluable to our company and his excitement about the data he has seen thus far on BICX101 has added to our confidence in the prospect of successful commercialization.”
BioCorRx Inc. (OTC PINK: BICX) is an addiction treatment company offering a unique approach to the treatment of substance abuse addiction. The BioCorRx® Recovery Program, a non-addictive, medication-assisted treatment (MAT) program, consists of two main components. The first component of the program consists of an outpatient implant procedure performed by a licensed physician. The implant delivers the non-addictive medicine, naltrexone, an opioid antagonist that can significantly reduce physical cravings for alcohol and opioids. The second component of the program developed by BioCorRx Inc. is a one-on-one counseling program specifically tailored for the treatment of alcoholism and other substance abuse addictions for those receiving long-term naltrexone treatment. The Company also has an R&D subsidiary, BioCorRx Pharmaceuticals, which is currently developing a new injectable naltrexone technology (BICX101) through a partnership with TheraKine Ltd. The company plans to seek FDA approval for BICX101.
For more information on BICX, visit www.BioCorRx.com.
Safe Harbor Statement
The information in this release includes forward-looking statements. These forward-looking statements generally are identified by the words "believe," "project," "estimate," "become," "plan," "will," and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties. Although the Company believes that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof.
Released November 28, 2016