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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 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.
About this update from Enzolytics Inc.
[{"type":"text","content":"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-...