61% Partial Response Rate of ADX-1612 in Combination with Platinum Therapy
LEXINGTON, MA, USA I September 25, 2018 I Aldeyra Therapeutics, Inc. (Aldeyra) (NASDAQ :ALDX ), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced positive top-line results from the MESO-2 investigator-sponsored Phase 1/2 clinical trial of ADX-1612 (ganetespib) in patients with pleural malignant mesothelioma. ADX-1612, when combined with standard pemetrexed and platinum therapy, resulted in partial response rates that exceeded historical standard of care. ADX-1612 is a selective inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone that controls the folding and activation of client proteins involved in DNA repair and cell division. Results will be announced at a presentation at the International Association for the Study of Lung Cancer (ASLC) 19th World Conference on Lung Cancer (Abstract #11921) on September 25, 2018.
“The MESO-2 results are highly encouraging. Addition of ADX-1612 to pemetrexed and either cisplatin or carboplatin achieved an overall response rate of 61%, the highest seen to date for addition of a novel agent to front-line chemotherapy” said Professor Dean Fennell MD PhD, Chief Investigator of the Cancer Research UK MESO-2 clinical trial. “Hsp90 inhibition could represent a new advance for the treatment of mesothelioma.”
The MESO-2 investigator-sponsored dose escalation clinical trial was designed to assess the safety, tolerability, and efficacy of ADX-1612 in combination with standard pemetrexed and platinum therapy, using either cisplatin or carboplatin. Twenty-seven patients with pleural malignant mesothelioma were enrolled at a single site in the UK and divided into one of three cohorts receiving 100, 150, or 200mg/m2 of ADX-1612 on days 1 and 15 every 21 days. Of 23 evaluable patients, 22 patients (96%) manifested stable disease or clinical response, and one patient (4%) with non-epithelial histology progressed, as measured by via RECIST (Response Evaluation Criteria in Solid Tumors) criteria. The overall response rate was 61%, relative to historical standard of care response rates of 20 to 40%. The response rate in patients with epithelial histology was 76%. In seven patients, reduction of tumor burden was greater than 50%. One patient remained progression-free after 37 months. ADX-1612 was observed to be well-tolerated, and dose-limiting toxicity was observed in three patients, all of whom were enrolled in the highest dose group.
“Malignant mesothelioma has no known cure, a poor prognosis, and a treatment landscape that has not changed in over a decade,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Based on the strength of the MESO-2 investigator-sponsored trial results relative to the unmet medical need in mesothelioma, we look forward to meeting with regulatory authorities to discuss these results.”
About ADX-1612
ADX-1612 (ganetespib) is a selective inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone that controls the folding and activation of client proteins involved in DNA repair and cell division. Aldeyra is developing ADX-1612 for the treatment of lymphoproliferative immune diseases and cancers in combination with DNA-damaging agents.
About Mesothelioma
Malignant pleural mesothelioma is a rare, aggressive cancer that develops in the pleura, a thin layer of tissue surrounding the lungs. Approximately 3,000 people are diagnosed each year in the United States. Response rates to chemotherapy are generally less than 40%, and five-year survival rates are less than 20%.
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead product candidate, reproxalap, is a first-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. The company is also developing other product candidates for autoimmune disease, post-transplant lymphoproliferative disease, retinal inflammation, metabolic disease, and cancer. None of Aldeyra’s product candidates have been approved for sale in the U.S. or elsewhere.
SOURCE: Aldeyra Therapeutics
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61% Partial Response Rate of ADX-1612 in Combination with Platinum Therapy
LEXINGTON, MA, USA I September 25, 2018 I Aldeyra Therapeutics, Inc. (Aldeyra) (NASDAQ :ALDX ), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced positive top-line results from the MESO-2 investigator-sponsored Phase 1/2 clinical trial of ADX-1612 (ganetespib) in patients with pleural malignant mesothelioma. ADX-1612, when combined with standard pemetrexed and platinum therapy, resulted in partial response rates that exceeded historical standard of care. ADX-1612 is a selective inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone that controls the folding and activation of client proteins involved in DNA repair and cell division. Results will be announced at a presentation at the International Association for the Study of Lung Cancer (ASLC) 19th World Conference on Lung Cancer (Abstract #11921) on September 25, 2018.
“The MESO-2 results are highly encouraging. Addition of ADX-1612 to pemetrexed and either cisplatin or carboplatin achieved an overall response rate of 61%, the highest seen to date for addition of a novel agent to front-line chemotherapy” said Professor Dean Fennell MD PhD, Chief Investigator of the Cancer Research UK MESO-2 clinical trial. “Hsp90 inhibition could represent a new advance for the treatment of mesothelioma.”
The MESO-2 investigator-sponsored dose escalation clinical trial was designed to assess the safety, tolerability, and efficacy of ADX-1612 in combination with standard pemetrexed and platinum therapy, using either cisplatin or carboplatin. Twenty-seven patients with pleural malignant mesothelioma were enrolled at a single site in the UK and divided into one of three cohorts receiving 100, 150, or 200mg/m2 of ADX-1612 on days 1 and 15 every 21 days. Of 23 evaluable patients, 22 patients (96%) manifested stable disease or clinical response, and one patient (4%) with non-epithelial histology progressed, as measured by via RECIST (Response Evaluation Criteria in Solid Tumors) criteria. The overall response rate was 61%, relative to historical standard of care response rates of 20 to 40%. The response rate in patients with epithelial histology was 76%. In seven patients, reduction of tumor burden was greater than 50%. One patient remained progression-free after 37 months. ADX-1612 was observed to be well-tolerated, and dose-limiting toxicity was observed in three patients, all of whom were enrolled in the highest dose group.
“Malignant mesothelioma has no known cure, a poor prognosis, and a treatment landscape that has not changed in over a decade,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Based on the strength of the MESO-2 investigator-sponsored trial results relative to the unmet medical need in mesothelioma, we look forward to meeting with regulatory authorities to discuss these results.”
About ADX-1612
ADX-1612 (ganetespib) is a selective inhibitor of heat shock protein 90 (Hsp90), a molecular chaperone that controls the folding and activation of client proteins involved in DNA repair and cell division. Aldeyra is developing ADX-1612 for the treatment of lymphoproliferative immune diseases and cancers in combination with DNA-damaging agents.
About Mesothelioma
Malignant pleural mesothelioma is a rare, aggressive cancer that develops in the pleura, a thin layer of tissue surrounding the lungs. Approximately 3,000 people are diagnosed each year in the United States. Response rates to chemotherapy are generally less than 40%, and five-year survival rates are less than 20%.
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead product candidate, reproxalap, is a first-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. The company is also developing other product candidates for autoimmune disease, post-transplant lymphoproliferative disease, retinal inflammation, metabolic disease, and cancer. None of Aldeyra’s product candidates have been approved for sale in the U.S. or elsewhere.
SOURCE: Aldeyra Therapeutics
Post Views: 73
