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BioCorRx Announces Orange County Research Center as Clinical Trial Site for First-In-Human Clinical Trial of BICX104

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BioCorRx Inc. (OTCQB: BICX) announced the completion of a clinical trial agreement with Orange County Research Center for its first-in-human trial of BICX104, a biodegradable naltrexone pellet aimed at treating opioid use disorder (OUD). This collaboration, led by Dr. Joel M. Neutel, signifies a major milestone for BioCorRx, as they seek FDA approval for the pellet. The trial is expected to commence once clinical samples are ready and participants are recruited. BICX104 is being developed with the National Institute on Drug Abuse, providing potential dual indications for OUD and Alcohol Use Disorder.

Positive
  • Completed clinical trial agreement with Orange County Research Center for BICX104.
  • BICX104 aims to treat opioid use disorder, with potential for dual indication for Alcohol Use Disorder.
  • Collaboration with National Institute on Drug Abuse supports BICX104's development.
Negative
  • None.

ANAHEIM, CA, Feb. 14, 2022 (GLOBE NEWSWIRE) -- via NewMediaWireBioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and related disorders, is pleased to announce that it has completed its clinical trial agreement with Orange County Research Center (OCRC), located in Tustin, CA, for its first-in-human clinical trial of BICX104, an implantable biodegradable naltrexone pellet for the treatment of opioid use disorder (OUD), which is being developed under BioCorRx Pharmaceuticals, Inc., the Company’s controlled R&D subsidiary. The principal investigator for the trial will be Dr. Joel M. Neutel M.D.  Dr. Neutel is the Director of Research at the Orange County Research Center, where he has served as study principal investigator on several hundred multinational cardiovascular and metabolic trials.

Dr. Neutel has authored numerous abstracts, journal articles and book chapters. He has conducted extensive research in such disciplines as cardiovascular medicine, endocrinology, and central nervous system disorders, with special attention to the pharmacotherapy of the diseases in these areas.

Brady Granier, President and Director of BioCorRx Inc. and CEO of BioCorRx Pharmaceuticals Inc., stated, “The selection of OCRC as the clinical trial site for our first-in-human clinical trial of BICX104 marks another major milestone for our Company. We believe OCRC is the perfect research partner as they have participated in over 400 clinical trials, advancing the development of many new treatments.  We look forward to working with Dr. Neutel, as he brings extensive experience serving the biopharmaceutical industry in the areas of clinical and academic research and he has been the principal investigator on other clinical trials involving implants.  We expect to begin the trial as soon as clinical samples are ready for release and when subjects for the study are recruited and screened.”

BICX104 is a biodegradable, long-acting subcutaneous pellet of naltrexone being developed in collaboration with the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), under RFA DA-19-002, “Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional).” The Company had a previous pre-IND meeting with the FDA, at which time the FDA deemed the 505(b)(2) abbreviated pathway acceptable, as well the opportunity to seek eventual dual indication on the product for OUD and Alcohol Use Disorder (AUD). 

About Orange County Research Center (OCRC)

OCRC is a therapeutically-focused early and late stage clinical development site offering a 50+ bed PK unit and a Phase II-IV clinic. Enrolling, managing and executing cutting edge clinical research protocols for large pharmaceutical and mid-sized biotechnical companies, OCRC has developed into a premier, patient-centered provider offering therapeutic expertise across an impressive therapeutic spectrum including but not limited to Cardiovascular Disease, Dermatology, Diabetes, Hypertension, Liver Disease, Nephrology and Wound Healing.

For more information please visit www.ocresearchcenter.com

About BioCorRx

BioCorRx Inc. (OTCQB: BICX) is an addiction treatment solutions company offering a unique approach to the treatment of substance use and other related disorders. Beat Addiction Recovery is a substance use disorder recovery program that typically includes BioCorRx's proprietary Cognitive Behavioral Therapy (CBT) modules along with peer support via mobile app along with medication prescribed by an independent treating physician under their discretion. The UnCraveRx® Weight Loss Program is also a medication assisted weight loss program that includes access to concierge on-demand wellness specialists: nutritionists, fitness experts and personal support from behavioral experts; please visit www.uncraverx.com for more information on UnCraveRx®. The Company also controls BioCorRx Pharmaceuticals, a clinical stage drug development subsidiary currently seeking FDA approval for BICX104, an implantable naltrexone pellet for treatment of alcohol and opioid use disorders. For more information on BICX and its subsidiary pipeline, please visit www.BioCorRx.com.

BioCorRx Inc.
investors@BioCorRx.com
714-462-4880
Investor Relations:
Crescendo Communications, LLC
(212) 671-1020 x304
bicx@crescendo-ir.com

Media Contact:
CMW Media
(858) 264-6600
biocorrx@cmwmedia.com


FAQ

What is the purpose of the BICX104 clinical trial?

The BICX104 clinical trial aims to evaluate the safety and efficacy of a biodegradable naltrexone pellet for treating opioid use disorder.

When is the BICX104 clinical trial expected to start?

The BICX104 clinical trial is expected to begin once clinical samples are ready and subjects are recruited and screened.

Who is leading the BICX104 trial at Orange County Research Center?

Dr. Joel M. Neutel will serve as the principal investigator for the BICX104 trial.

What are the potential market implications of BICX104?

BICX104 has potential market implications as it addresses the opioid crisis, with a dual indication for opioid and alcohol use disorders.

What previous approvals has BioCorRx received from the FDA regarding BICX104?

BioCorRx had a pre-IND meeting with the FDA, which deemed the 505(b)(2) pathway acceptable for BICX104.

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