The Company completed a contract with Bovine Collagen Products (BCP) to manufacture its proprietary collagen scaffolds, the platform on which skin cells are grown to produce NovaDerm®. The Company also completed a contract with Pure Med Farma, LLC (PMF) which will supply closed herd collagen to produce the proprietary scaffold. The use of closed herd collagen is now a requirement outlined in FDA guidance documents to ensure animal source materials are safe for use in humans.
In August, Regenicin secured an Orphan Designation, as a biologic, from the Office of Orphan Products Development. The FDA's Orphan designation is granted to promote the development of unmet clinical needs with new therapies for rare diseases and disorders. Once approved as an Orphan Product, NovaDerm® would be granted 7 years of market exclusivity by the FDA. In addition, there are other financial benefits along with the FDA's support during the approval process.
In September, Regenicin submitted a pre-IND meeting request and met telephonically with FDA officials at the end of October 2016. The Agency addressed Regenicin's questions and provided guidance on the Company's planned NovaDerm® development pathway going forward. It was agreed that PMF would perform the testing and specifications as per the American Society for Testing and Materials to fulfill current ASTM F2212-11 requirements. Regenicin is working closely with PMF to ensure this testing can be completed promptly.
And finally, Regenicin selected a well-known and respected global Clinical Research Organization (CRO) that will assist with the final Investigational New Drug (IND) application submission and the clinical trial process, including site selection, documentation, physician training, patient recruitment and a final clinical report on the results of the trials. An IND application is the document filed with the FDA to request permission to proceed with clinical trials. This application includes the candidate product's research and development, chemistry manufacturing controls and processes, pre-clinical safety, related product studies, clinical trial protocols, and development history.
Milestones for 2017
The primary initiative for the first quarter of 2017 is to raise additional funds to finalize the data needed for submitting the IND application. It is estimated that the cost to complete the IND will be approximately $1.5 million, and the cost to complete the Phase I clinical trial will be approximately $2 million. The main focus in obtaining this funding is to minimize shareholders' dilution as much as possible. Consequently, Regenicin is primarily pursuing financing through the issuance of a debt instrument, as well as international licensing agreements.
Regenicin has begun the preliminary planning for the clinical trials to the extent the Company is able based on funding constraints. As mentioned above, Regenicin has chosen a CRO to assist in the IND submission and conducting the trials. Clinical site selection and patient recruitment should be faster than normally expected, as the Company is only scheduling 10 subjects at two burn centers.
In Summary, Regenicin intends to achieve the following milestones in 2017:
- Secure interim financing to finalize product development and testing needed to support the IND
- Complete a second round of financing in order to conduct 10 subject clinical trial with NovaDerm®
- Work with Pure Med Farma to finalize Collagen Scaffold Testing and Specifications for NovaDerm®
- Finalize contracts with the CRO and select the NovaDerm® manufacturer
- Retain a Principal lead investigator, medical advisor, surgical trainer and dermopathologist
- Select and execute contracts with two clinical study sites
- Enroll first subject into the trial
- Perform successful grafts of NovaDerm onto clinical trial subjects
Regenicin, Inc. (OTC Bulletin Board: RGIN), is a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs. Regenicin, which was founded in 2010, has assembled a world-class management team with a proven track record for developing and bringing innovative medical devices and biotechnology products to market. The company is publicly traded with headquarters in New Jersey. For more information on Regenicin, Inc., as well as its technologies and products, please visit the company website at www.regenicin.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company's current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company's business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Regenicin, Inc.