ALLEN, TX / ACCESSWIRE / July 1, 2024 / Enzolytics, Inc. (OTC PINK:ENZC) ("enzolytics.com") (the "Company") announced today that the Company is entering into a worldwide exclusive licensing agreement for US Patent # 8067531-B2, "Inactivated pepsin fragments for modulating immune system activity against human malignant tumor cells," applying Immunotherapy Treatment to the global fight against cancer. ENZC continues to explore therapeutic applications of the patent, and is preparing to commence Federal Drug Administration ("FDA") in-vitro studies. ENZC has developed a Statement of Work with a major university in Texas to further this effort.
In the interim, the Company will pursue various regulatory paths under "Right to Try Laws" for application to terminally ill stage four cancer patients. This could be achieved by approval of an individual IND to help prolong lives. Immune treatment, such as ITP-immune therapeutic protein, does not substitute for existing chemo therapy treatments.
Additionally, Dr. Lachezar Ivanov, Director of ENZC and member of the Bulgarian Senate, is negotiating the acquisition of a pharmaceutical manufacturing facility in Bulgaria which meets the Good Manufacturing Process ("GMP") standard required by the European Medicine Association ("EMA"). The manufacturing facility will be an integral part of the ENZC portfolio of products for the nutraceutical market as well as the manufacturing and distribution of its other licensed immunotherapy treatments.
Sagaliam Acquisition Corp. ("SAGA") has provided the Company with an update on multiple efforts including its application with OTC Markets. Currently, SAGA has secured funding for completion of the necessary audits required for the next steps toward completion of its application for membership on the OTC board and has engaged a PCAOB auditor.
Operationally, SAGA has filed two new patent applications, one for its Multiple Sclerosis immunotherapy treatment, for which a provisional application was previously filed, and the other for the Peptide Complex modulation of the immune system. A worldwide license will be awarded by the patent owner for both treatments to SAGA. Progress is being made to move forward with clinical trials in Europe to assess the effects of ITV-1 on diabetic patients. Additionally, progress continues to be made on the permitting of ITV-1 for treatment of HIV/Aids with the EMA.
SAGA and ENZC are coordinating the dividend approval process of the shares issued in association with the sale by ENZC of Virogentics, Inc. to SAGA in September of last year. The make-whole provision will apply to all shares distributed to ENZC shareholders.
Harry Zhabilov, Chief Science Officer of ENZC and SAGA, stated, "Enzolytics' licensing of the Cancer immunotherapy treatment is an expansion of its cutting edge portfolio of technology IP and products. The continued growth of the product base of the Company and Saga will give us the opportunity to utilize the skills, experience and expertise of our management team and partners."
Steve Sharabura, the CEO of Enzolytics commented, "In addition to the exciting progress on intellectual property, we will continue to build a robust IP portfolio going forward. We are also enthusiastic about moving forward on our ETC Marketing initiative, with an initial focus on consumer sales of nutraceutical products. With the current explosion of online communities, we appreciate the value of digital marketing and the power of social media augmented by AI. As we expand our consumer engagement through ETC Marketing, we will also use these tools to increase engagement with our investors and expand awareness and education related to our well-being therapies."
Barry Kostiner, the CEO of Sagaliam commented, "We are looking forward to regaining compliance and getting SAGA listed on OTC. Historically, Enzolytics' valuation has exceeded $500M, reflecting the value of the ITV-1 intellectual property embedded in Virogentics. Once the SAGA OTC listing is in place, we will be able to issue the dividend of SAGA shares to Enzolytics, and complete the funding needed to move forward on clinical trials and bring ITV-1 to market. Our technology has been well established, and we have only a few regulatory steps needed to bring value to SAGA and ENZC shareholders and make significant contributions to global health. The application to HIV in Europe and Africa will be well on its way within 6 months of completing the SAGA OTC listing, and work on applications to diabetes and cancer would commence within another 6 months.
About Enzolytics, Inc.
Enzolytics, Inc. is transitioning from a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat debilitating infectious diseases to a sales, marketing and distribution entity focusing on medical devices, medical testing and nutraceutical products.
Forward Looking Statements
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CONTACT INFORMATION
Enzolytics, Inc. Steve Sharabura, Chief Executive Officer 3002 Royal Palm Baytown, Texas 77523 Tel: (845) 925-4597 X/Twitter: @EnzolyticsInc
