Enzolytics Reports Its Engagement of Scendea USA, Inc., a Leading International Product Development and Regulatory Consulting Group, To Guide the Progress Toward Clinical Trials and Market Approval for Its Itv-1 Anti-HIV Therapeutic
Enzolytics, Inc. has engaged Scendea USA, Inc. to advance its anti-HIV therapeutic ITV-1 toward clinical trials and market approval under both EU and FDA regulations. Scendea will focus on reducing development costs and time-to-market. Enzolytics has secured production agreements and is finalizing a comprehensive clinical development plan. The company is also developing a range of therapeutic monoclonal antibodies targeting infectious diseases. Despite advancements, ITV-1 is not yet FDA approved, highlighting inherent risks in achieving commercialization.
- Engagement of Scendea USA for regulatory consulting to expedite ITV-1 approval.
- Production agreements in place with Danhson for ITV-1.
- Comprehensive clinical development plan being finalized for ITV-1.
- ITV-1 is not yet FDA approved, posing risks to commercialization timelines.
- Forward-looking statements may not guarantee future success in clinical trials.
COLLEGE STATION, TX / ACCESSWIRE / December 29, 2021 / Enzolytics, Inc. has engaged Scendea USA, Inc. (www.scendea.com), a leading international product development and regulatory consulting group, to advance its anti-HIV therapeutic ITV-1 to production, clinical trials and market approval under both the European Medicines Act (EMA) and the U.S. FDA regulatory process.
Scendea is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. Scendea's service will focus on reducing time-to-market and minimizing development costs. Scendea's team offers strategic and operational support in quality/CMC, non-clinical/toxicology, clinical/medical, and regulatory, guiding the Company's product ITV-1 efficiently to market approval.
Scendea's critical role in the approval process is one of finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis and a necessary EU Regulatory Strategy.
Enzolytics Inc. currently has in place engagements for the product production by Danhson (https://danhson.bg/en/) and clinical trials at Clinic Design (https://clinicdesign.eu/) to advance its anti-HIV therapeutic ITV-1 to the final stage of regulatory approval by the European Medicines Agency (EMA), leading to patient use authorization. Additionally, Scendea will also assist with the FDA approval process to expeditiously introduce ITV-1 to the North American market.
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.
The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including the CoronaVirus, HIV, HTLV-1, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology, covered in pending U.S. Patent Application Ser. No. 63/245,122 for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.
Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.
While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.
Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.
I.R. contact:
TEN Associates, LLC
Tom Nelson, CEO
(480) 326-8577
Investor Relations Contact
Company Contact:
Enzolytics, Inc.
2000 North Central Expressway
Plano, TX 75074
and
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44
SOURCE: Enzolytics, Inc.
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FAQ
What is the purpose of ITV-1 by Enzolytics (ENZC)?
What role does Scendea USA play in the development of ITV-1?
What are the next steps for ITV-1 after this engagement?
What are the risks associated with ITV-1 according to the press release?
