Nascent Submits Phase 2 Clinical Research Protocol to FDA for Review and Approval

Rhea-AI Summary

Nascent Biotech, Inc. (OTCQB:NBIO) has submitted the Protocol for its Phase 2 clinical trials of Pritumumab (PTB) to the FDA for review, marking a crucial step in advancing treatment for brain cancers.

The submission includes data from the Phase 1 Clinical Research focused on the safety and tolerance of PTB. This natural human antibody is designed to target and bind to vimentin, a protein found on epithelial cancer cells, thereby offering a targeted approach to immunotherapy.

The Company expects initial feedback from the FDA within 30 days of the submission. Nascent Biotech is dedicated to developing monoclonal antibodies aimed at treating various cancers and viral infections.

Positive

• Submission of Phase 2 clinical trial protocol to the FDA for Pritumumab (PTB).
• Data from Phase 1 trials demonstrating safety and tolerance of PTB.
• PTB's mechanism targets only cancer cells, minimizing damage to healthy cells.
• Anticipation of FDA feedback within 30 days.

Negative

• None.

NORTH PALM BEACH, FL / ACCESSWIRE / April 18, 2023 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in the brain cancer space, announced today that the Protocol for the Phase 2 clinical trials was submitted to the FDA for review and approval. The review is required for approval to commence the next phase in the development of Pritumumab ("PTB"). Data related to Phase 1 Clinical Research evaluating safety and tolerance for PTB as a treatment for Primary and Metastatic Brain Cancers has also been submitted to the FDA. The Company anticipates initial comments from the FDA approximately 30 days from the date of filing.

PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy and seek out only cancer cells without damaging healthy cells.

About Nascent Biotech

Nascent Biotech, Inc. (OTCQB: NBIO) is a clinical-stage biotech company pioneering the development of monoclonal antibodies to be used in the treatment of various cancers and viral infections, helping people worldwide. Its products are not yet commercially available. The Company's lead candidate, Pritumumab (PTB), is a monoclonal Antibody (Mab) that is being studied in Phase I clinical trials for the treatment of Brain Cancer.

For further information please visit our website www.nascentbiotech.com.

Forward Looking Safe Harbor Statement

Statements in this press release about our future expectations constitute 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time and our actual results could differ materially from expected results. These risks and uncertainties include, without limitation, Nascent Biotech Inc's ability to target the medical professionals; Nascent Biotech Inc's ability to raise capital; as well as other risks. Additional information about these and other factors may be described in the Nascent Biotech Inc's Form 10, filed on May 2, 2015, and future subsequent filings with the Securities and Exchange Commission. The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.

Corporate Contact
Sean Carrick | CEO | Nascent Biotech, Inc.
sean.carrick@nascentbiotech.com

Public Relations
EDM Media, LLC
https://edm.media
(800) 301-7883

SOURCE: Nascent Biotech Inc.

View source version on accesswire.com:
https://www.accesswire.com/749560/Nascent-Submits-Phase-2-Clinical-Research-Protocol-to-FDA-for-Review-and-Approval

FAQ

What is the purpose of the Phase 2 clinical trials for NBIO?

The Phase 2 clinical trials aim to further evaluate the safety and effectiveness of Pritumumab (PTB) as a treatment for primary and metastatic brain cancers.

When did NBIO submit the Phase 2 protocol to the FDA?

Nascent Biotech submitted the Phase 2 clinical trial protocol to the FDA on April 18, 2023.

What is Pritumumab (PTB) used for?

Pritumumab (PTB) is a monoclonal antibody being studied for its ability to treat brain cancers by targeting cancer cells while sparing healthy tissue.

How long will it take for NBIO to receive FDA feedback on their trial submission?

Nascent Biotech expects to receive initial comments from the FDA approximately 30 days after their submission.

What stage is Pritumumab (PTB) currently in regarding clinical trials?

Pritumumab (PTB) is currently in the Phase 1 clinical trials, with the protocol for Phase 2 under review by the FDA.