Successful meeting with USFDA to file an IND application to initiate phase III clinical trial of centhaquine in patients with hypovolemic shock

Saturday, February 8, 2020 Clinical Trials News
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Excellent progress in enrollment of patients to evaluate Sovateltide (PMZ-1620), a first-in-class investigational product, for acute cerebral ischemic stroke

WILLOWBROOK, Ill., Feb. 7, 2020 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced the appointment of Dr. Guru Reddy as Executive Vice-President. Dr. Reddy was Vice-President at Spectrum Pharmaceuticals, Inc. before joining Pharmazz, Inc. He was an integral part of the team that managed development of 4 USFDA approved drug products and has more than 20 years of experience in pharmaceutical industry. Dr. Guru Reddy said that, "I am delighted to join Pharmazz and look forward to working with the talented team to develop and commercialize innovative therapies for life threatening conditions."

The company announces enrollment of 42 patients in its pivotal, phase III clinical trial evaluating sovateltide for the treatment of acute cerebral ischemic stroke. The first patient was dosed on November 10, 2019 as part of multicentric, randomized study (NCT04047563) in India. The trial is expected to enroll approximately 110 patients with acute cerebral ischemic stroke and top-line results from this phase III trial are expected by Q3 of 2020. The results of phase II study (NCT04046484) indicate that clinical outcomes of NIHSS, mRS and BI on day 6 showed highly statistically significant improvements in the sovateltide group compared to standard treatment.

Company had a successful face-to-face meeting with USFDA on December 3rd, 2019 to file an IND application to initiate phase III clinical studies in the USA.

The company further announces notice of allowance from United States Patent and Trademark Office that application titled "Compositions and Methods for Treating Neuropsychiatric Disorders Using an Endothelin-B Receptor Agonist" will issue as Patent No. 10,561,704 on February 18, 2020. Issuance of this patent strengthens our intellectual property on sovateltide in stroke and other neurodegenerative diseases.

About Pharmazz, Inc.  Pharmazz, Inc. is a privately held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company's website, www.pharmazz.com.  

Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties including the risk that Pharmazz, Inc. cannot execute its business plan for lack of capital or other resources, distribution, partnering or licensing/acquisition opportunities. Actual events or results may differ materially from those projected in any of such statements due to various factors. Any of these risks could cause Pharmazz, Inc. or its industry's, actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this presentation. Except as required by applicable law Pharmazz, Inc. does not intend to update any of the forward-looking statements to conform these statements to actual results.

ContactPharmazz, Inc.   Shruti Gulati630-780-6087shruti.gulati@pharmazz.com 

 

Cision View original content:http://www.prnewswire.com/news-releases/successful-meeting-with-usfda-to-file-an-ind-application-to-initiate-phase-iii-clinical-trial-of-centhaquine-in-patients-with-hypovolemic-shock-301001139.html

SOURCE Pharmazz, Inc.



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