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CNS Provides Update on Development Agreement for WP1122

HOUSTON, May 27, 2020 /PRNewswire/ --A CNS Pharmaceuticals, Inc., (Nasdaq: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided an update on the development of WP1122. As previously announced, CNS entered into an agreement with WPD Pharmaceuticals for the development of several preclinical drug candidates for antiviral indications, including WP1122, in certain territories. WPD Pharmaceuticals previously licensed rights to WP1122, from Moleculin Biotech, Inc. (Moleculin) for certain territories.
CNS Provides Update on Development Agreement for WP1122
Today, Moleculin announced that on May 1, 2020 it submitted a request to the US Food and Drug Administration ("FDA") for a Pre-IND Meeting to seek guidance on requirements for submitting an Investigational New Drug ("IND") application to study its drug candidate, WP1122, in a clinical trial for patients with COVID-19, and that on May 6, 2020, the FDA granted Moleculin's meeting request, and indicated that its goal for providing written responses is June 30, 2020, but that it plans to act early on this meeting request, provided there are no significant deficiencies in the Pre-IND package or unexpected shifts in its work priorities. Moleculin further stated that it may be able to submit its IND application in the second half of this year. More specific timing will depend upon the guidance Moleculin receives from its Pre-IND Meeting with the FDA.Additionally, Moleculin announced that it engaged ImQuest BioSciences ("ImQuest") and the Illinois Institute of Technology Research Institute ("IITRI"). IITRI is initially focused on preclinical toxicology testingA to help determine whether WP1122 can be considered safe for testing in humans. ImQuest conducted two rounds of preclinical assessment of the potential for WP1122 to address COVID-19. The first round was to demonstrate whether or not the improved pharmacology of WP1122 gave it a greater therapeutic window than 2-DG. The second round was to demonstrate the ability of WP1122 to inhibit coronavirus production in mammalian cell culture. The testing done by ImQuest was performed on a surrogate of SARS-CoV-2 called Human coronavirus strain 229E ("HCoV-229E").Although these in vitro results should not be considered conclusive or indicative of what will happen in vivo,A the initial results, received by Moleculin on May 4, 2020, showed that both 2-DG and WP1122 have an antiviral effect on HCoV-229E. WP1122 displayed a greater therapeutic index than 2-DG, while the virus yield reduction assay demonstrated a 5 to 10-fold inhibition of coronavirus production by WP1122 and 2-DG when compared to untreated virus control. Moleculin is having ImQuest repeat its tests to provide additional confidence in its findings.A In addition to having ImQuest repeat their tests, Moleculin announced that it is arranging for additional in vitro testing to include additional human cell lines and the use of a validated SARS-CoV-2 assay, as well as testing against other pathogenic viruses. The Company cautions readers that these results are initial and are not conclusive.A 
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