NetworkNewsBreaks – Genprex Inc. (NASDAQ: GNPX)
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Posted On: 08/10/2023 3:33:45 PM
NetworkNewsBreaks – Genprex Inc. (NASDAQ: GNPX) Granted FDA Orphan Drug Designation for REQORSA(R) for Patients with SCLC
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing treatments for patients with cancer and diabetes, today announced that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to the company’s lead drug candidate, REQORSA(R) Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (“SCLC”). In addition to ODD for the treatment of SCLC, in June 2023, the FDA granted Fast Track Designation (“FTD”) for REQORSA Immunogene Therapy, in combination with Genentech Inc.’s Tecentriq(R) in patients with extensive-stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The FDA has also granted Genprex FTD for two other indications of REQORSA Immunogene Therapy, including REQORSA in combination with Tagrisso for non-small cell lung cancer (“NSCLC”) in patients who have progressed after Tagrisso treatment, and REQORSA in combination with Keytruda for NSCLC in patients who have progressed after Keytruda treatment. “We are excited to receive Orphan Drug Designation from the FDA for REQORSA for patients with SCLC,” said Rodney Varner, president, chairman and CEO at Genprex. “This FDA Orphan Drug Designation in combination with our recently received FDA Fast Track designation underscores the great need for better treatment options for patients with SCLC, ES-SCLC and NSCLC. We look forward to initiating the Acclaim-3 clinical trial expected in the fourth quarter of 2023 in order to bring hope of an effective new therapy to patients suffering with this life-limiting cancer.”
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing treatments for patients with cancer and diabetes, today announced that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to the company’s lead drug candidate, REQORSA(R) Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (“SCLC”). In addition to ODD for the treatment of SCLC, in June 2023, the FDA granted Fast Track Designation (“FTD”) for REQORSA Immunogene Therapy, in combination with Genentech Inc.’s Tecentriq(R) in patients with extensive-stage small cell lung cancer (“ES-SCLC”) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The FDA has also granted Genprex FTD for two other indications of REQORSA Immunogene Therapy, including REQORSA in combination with Tagrisso for non-small cell lung cancer (“NSCLC”) in patients who have progressed after Tagrisso treatment, and REQORSA in combination with Keytruda for NSCLC in patients who have progressed after Keytruda treatment. “We are excited to receive Orphan Drug Designation from the FDA for REQORSA for patients with SCLC,” said Rodney Varner, president, chairman and CEO at Genprex. “This FDA Orphan Drug Designation in combination with our recently received FDA Fast Track designation underscores the great need for better treatment options for patients with SCLC, ES-SCLC and NSCLC. We look forward to initiating the Acclaim-3 clinical trial expected in the fourth quarter of 2023 in order to bring hope of an effective new therapy to patients suffering with this life-limiting cancer.”
Please see full terms of use and 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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