NetworkNewsBreaks – CNS Pharmaceuticals Inc. (NA
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Posted On: 06/29/2021 3:33:32 PM
NetworkNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Receives FDA Fast Track Status for Berubicin Study
CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, announced that the U.S. Food and Drug Administration granted Fast Track Designation for Berubicin, the company’s lead investigational drug. The status was received for the company’s evaluation of Berubicin for the treatment of patients with recurrent glioblastoma multiforme (“GBM”). An anthracycline, Berubicin falls in a class of anticancer agents that are among the most powerful chemotherapy drugs, proven to be effective against more types of cancer than any other category of chemotherapeutic agents. Fast Track Designation provides opportunities to expedite the development and review process for drugs intended to treat serious or life-threatening conditions when those drugs show potential to address unmet medical need. CNS has already begun patient enrollment in its upcoming study of Berubicin for the treatment of recurrent glioblastoma multiforme. “Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain,” said CNS Pharmaceuticals CEO John Climaco in the press release. “If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options, and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, announced that the U.S. Food and Drug Administration granted Fast Track Designation for Berubicin, the company’s lead investigational drug. The status was received for the company’s evaluation of Berubicin for the treatment of patients with recurrent glioblastoma multiforme (“GBM”). An anthracycline, Berubicin falls in a class of anticancer agents that are among the most powerful chemotherapy drugs, proven to be effective against more types of cancer than any other category of chemotherapeutic agents. Fast Track Designation provides opportunities to expedite the development and review process for drugs intended to treat serious or life-threatening conditions when those drugs show potential to address unmet medical need. CNS has already begun patient enrollment in its upcoming study of Berubicin for the treatment of recurrent glioblastoma multiforme. “Receiving Fast Track Designation from the U.S. FDA is a huge achievement in our advancement of Berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain,” said CNS Pharmaceuticals CEO John Climaco in the press release. “If there were ever a disease where the unmet clinical need demands action, it is GBM. Patients have almost no meaningful options, and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for Berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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