BioCorRx Announces Updates on Preclinical Studies of BICX101 and Pre-IND Meeting Request with FDA
ANAHEIM, CA / ACCESSWIRE / March 21, 2017 / BioCorRx Inc. (OTC PINK: BICX) (the "Company"), a developer and provider of advanced solutions in the treatment of alcohol and opioid addictions, today announced positive preliminary data from preclinical studies evaluating BICX101, a sustained release, injectable naltrexone for the treatment of opioid abuse and alcoholism. Thus far in the preclinical studies, the product is successfully delivering above adequate sustained release levels of naltrexone. The study has so far confirmed a number of the expected advantages of BICX101. The Company is also expecting Innovative Science Solutions (ISS) to finalize and submit the Pre-IND meeting request application in the first week of April.
Brady Granier, CEO, President, and Director, stated, "This third round of in vivo studies has produced some very exciting results thus far. We still have a couple more weeks or so before this study is completed and the final report from Covance is delivered. What is particularly exciting about this round of data is that we have discovered that we may have two different lead formulations that may lead to 2-3 different types of products in the future. Our primary goal is to achieve a once a month injectable product in a low volume and small needle, along with many other advantages over current products, but what we discovered in the last few weeks of studies may lend itself to another possible product. We have also discovered that we can deliver two weeks of drug release in vivo in a very low volume of approximately 0.5 ml. This could lead to the possibility of a self-administered, at-home product. The implications of this can be very profound in terms of how alcohol abuse and opioid overdose protocols are amended in the future. Alcohol Use Disorder (AUD) is a much larger problem than alcohol addiction, as many abuse alcohol without necessarily being addicted. A product such as this might be used for harm reduction for those who have an alcohol use problem, but not yet full-blown addiction. In terms of opioid overdose reversal using naloxone, there could be an opportunity for a product to be administered after naloxone, which can add further protection to that individual by extending overdose protection by a couple of weeks. Of course, more investigation will need to take place for these indications, but the feedback from addiction experts on these is very positive. With regard to our main objective of the monthly injectable, we have identified at least two formulations that are releasing the drug quite nicely in vivo and we are anticipating more data points in the very short term."
"We are also working with ISS to finalize the Pre-IND meeting request, as we feel confident that we have enough data to have a meeting with the FDA. We expect to have additional data by the time the actual meeting occurs. Once the meeting is requested, it can typically take 60 days for the actual meeting to take place, but that is not controlled by us. More updates on additional results of the preclinical studies, as well as the Pre-IND meeting, are anticipated in the coming weeks."
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 and/or its naltrexone implant product(s). 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.
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SOURCE: BioCorRx Inc.
Released March 21, 2017