Curative Biotechnology Announces Good Laboratory Practice (GLP) Toxicology Studies with Metformin Eye Drop Formulations for Treatment of Macular Degeneration
Curative Biotechnology, Inc. (CUBT) announced a collaboration with the National Eye Institute (NEI) under a Cooperative Research and Development Agreement (CRADA) to advance its metformin formulation for treating Age-Related Macular Degeneration (AMD). The company is conducting a Good Laboratory Practice (GLP) toxicology study to evaluate the formulation's tolerability, pharmacokinetics, and ocular tissue distribution, crucial for an FDA Investigational New Drug (IND) filing. This study involves comprehensive ocular assessments by certified specialists.
- Collaboration with NEI enhances credibility and potential for clinical study advancements.
- Advancement into GLP toxicology study indicates progress towards FDA IND filing.
- CUBT is not generating revenues, raising concerns about financial viability.
- Reliance on forward-looking statements suggests uncertainty in achieving projected outcomes.
National Eye Institute (NEI) to Collaborate with Curative Biotechnology under Cooperative Research and Development Agreement (CRADA)
Boca Raton, FL, May 03, 2022 (GLOBE NEWSWIRE) -- Curative Biotechnology, Inc. (OTC: CUBT) (“Curative Biotech” or the “Company”), a development-stage biomedical company focused on novel treatments for rare diseases and conditions, announced today the company has advanced into its Good Laboratory Practice (GLP) toxicology study.
The current study is designed to gauge tolerability, pharmacokinetics and any local or systemic toxicity of reformulated metformin when administered by topical ocular delivery. The study will also assess its ocular tissue distribution.
The Good Laboratory Practice (GLP) toxicology study is a requirement for an FDA Investigational New Drug (IND) filing.
Ocular tolerance includes observations at dosing, general clinical observations twice daily (evaluation of behavior/clinical signs with particular attention paid to the eyes), ophthalmic examinations by a Board-certified veterinary ophthalmologist according to the modified Hackett-McDonald scoring scale, and ocular histopathology.
Under a Cooperative Research and Development Agreement (CRADA), the National Eye Institute (NEI) and Curative Biotechnology, Inc. will collaborate to evaluate Curative’s proprietary ocular metformin formulation in clinical studies for the treatment of intermediate and late-stage Age-Related Macular Degeneration (AMD) disease.
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About Curative Biotechnology, Inc. http://curativebiotech.com
Curative Biotechnology, Inc. (Curative Biotech) is a development stage biomedical company focused on novel therapies for rare diseases. The Company is focused on identifying, acquiring and developing disease modifying therapeutic drug candidates with a concentration on rare disease indications. Curative Biotech has ongoing programs in three different therapeutic areas: infectious disease, neuro oncology and degenerative eye disease. The Company's pipeline includes IMT504, CURB906 and Metformin Reformulation. IMT504 is a novel immune therapy to treat rabies and an adjuvant for vaccines, CURB906 is a fully humanized CD56 monoclonal antibody carrying a cytotoxic drug conjugate directly to the tumor cancer site to kill the tumor by inhibiting tumor growth and migration of the tumor. Metformin Reformulation is targeting the treatment of intermediate and late-stage Age-Related Macular Degeneration (AMD) disease.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. CUBT is not yet generating revenues. Although forward-looking statements in this release reflect the good faith judgment of management, forward-looking statements are inherently subjected to known, unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements, including but not limited our ability to generate sufficient market acceptance for our products and services, our ability to generate sufficient operating cash flow, and general economic conditions. Readers are urged to carefully review and consider the various disclosures made by us in our reports filed with OTC Markets from time to time which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. We assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
Contact:
Steve Chizzik
Investor Relations
Curative Biotech (CUBT)
201-454-5845
ir@curativebiotech.com
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