Nascent Prepares for Pivotal Phase II Research with Fresh Manufacturing Run

Rhea-AI Summary

Nascent Biotech, Inc. prepares for a pivotal Phase II research by embarking on a fresh manufacturing run to ensure maximum potency of Pritumumab supplies for the upcoming clinical trial. The Company aims to prioritize patient outcomes and long-term shareholder value by taking careful steps in the trial process. The Phase I trial showed promising safety results, especially in treating Glioblastoma, with no dose-related toxicities. The Phase II trial will focus on clinical outcomes and efficient patient recruitment.

NORTH PALM BEACH, FL / ACCESSWIRE / April 16, 2024 / Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company developing monoclonal antibodies targeting various cancer types, announces that it is embarking on a fresh manufacturing run to ensure Pritumumab ("PTB") supplies are at maximum potency when patient dosing begins in the upcoming Phase II clinical trial.

"Taking the time to navigate this opportunity with proper care and diligence is a step that demonstrates our commitment to the best interests of our investors, partners, shareholders, and potential future patients," remarked Sean Carrick, CEO of NBIO. "No one likes delays, but patience and care at this critical stage is necessary in maximizing patient outcomes and long-term shareholder value. We want to be careful not to make hasty decisions while exploring all options.

This announcement comes as the Company prepares for a Phase II trial that follows a very successful Phase I trial-where safety at five ascending dose cohorts was observed-involving 15 patients who received PTB for various types of brain tumors. The most common and most challenging to treat tumor type in the trial was Glioblastoma. 12 of 15 patients had this diagnosis.

There were no dose-related toxicities. Overall, the study found that single agent Pritumumab is safe up to a dose of 16.2 mg/kg every 7 days in brain tumor patients. One partial response showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study.

Mr. Carrick continued, "Phase I demonstrated an excellent safety profile at various doses. Phase II will be focused on clinical outcomes, and we are taking no shortcuts. We have been in discussions with potential Phase II study sites to ensure patients are being actively recruited and the most efficient process in place once we are ready to begin dosing."

Management anticipates that some research sites will open for the start of Phase II testing late this summer with actual patients involved later in 2024.

ABOUT NASCENT

Nascent Biotech, Inc. (OTCQB:NBIO) is a phase 2 clinical-stage biotech company pioneering the development of human monoclonal antibodies to be used in the treatment of various cancers, helping people worldwide. The Company's lead candidate, Pritumumab (PTB), is a human monoclonal Antibody (Mab) that has progressed to Phase 2 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 | President | CEO | Nascent Biotech, Inc.
772.713.0541 Cell | sean.carrick@nascentbiotech.com

Public Relations

EDM Media, LLC
https://edm.media

SOURCE: Nascent Biotech Inc.

View the original press release on accesswire.com

FAQ

What is Nascent Biotech, Inc. preparing for?

Nascent Biotech, Inc. is preparing for a pivotal Phase II research by embarking on a fresh manufacturing run to ensure maximum potency of Pritumumab supplies for the upcoming clinical trial.

What did the Phase I trial of Nascent Biotech, Inc. involve?

The Phase I trial involved 15 patients receiving PTB for various types of brain tumors, with promising safety results and no dose-related toxicities.

What was the most common tumor type in the Phase I trial?

The most common and challenging to treat tumor type in the Phase I trial was Glioblastoma, with 12 out of 15 patients having this diagnosis.

What was the outcome of the Phase I trial in terms of patient response?

One patient showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study, indicating a positive response to treatment.

What is the focus of the upcoming Phase II trial?

The upcoming Phase II trial will be focused on clinical outcomes, with an emphasis on efficient patient recruitment and ensuring maximum patient benefit.