San Diego, CA August 13, 2015 – Nascent Biotech, Inc. (“Nascent Biotech, Inc.” or “the Company”) (OTC.NBIO).
Since March of 2014 Nascent has raised $2.1 million which has been used to advance the development of their core product, Pritumumab, to support the filing of an Investigational New Drug exemption (IND). Pritumumab is a fully human monoclonal antibody being developed initially for the treatment of malignant and non malignant Gliomas.
One of the biggest challenges in the development of any antibody product is to show that it can be manufactured, at appropriate scale, to clinical grade and in sufficient quantity for human trials. We have attained this goal and manufactured more than enough product to complete our initial Phase 1/Phase 2 human trials on Brain Cancers, with more than adequate amounts left over to initiate trials in other epithelial cancers such as breast, lung, colon and pancreas. Pritumumab is unique in its ability to react strongly with all these major malignancies.
An additional challenge is to understand the toxicity profile. We have completed a toxicology study, in compliance with FDA guidance, and we have demonstrated no in life toxicities in the two species studied (Monkey and Rat).
Another significant milestone worth noting is that the FDA granted Nascent Biotech an Orphan Drug Designation for Gliomas (brain cancer). “This will give us market exclusivity for a period of 7 years after the drug is approved,” says Nascent President Sean Carrick.
About Nascent Biotech, Inc.:
Nascent Biotech, Inc is a clinical-stage biotech company engaged in the development of monoclonal antibodies to be used in the treatment of various cancers. Its products are not commercially available. For further information please visit our website www.nascentbiotech.com.
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 October 28, 2014, and future 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.
Nascent Biotech, Inc.