Based on encouraging progression-free survival data, Lpath extends the study to a second cohort and considers additional proof-of-concept studies
SAN DIEGO, CA, USA I July 24, 2014 I Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, reported interim results in a Phase 2a single-arm, open-label trial where ASONEP™ is being investigated as a treatment for metastatic renal cell carcinoma (RCC) in patients that have failed at least one therapy involving a VEGF inhibitor (e.g., Sutent®/ sunitinib maleate) and no more than one mTOR inhibitor (e.g., Afinitor®/everolimus), with a maximum of three failed treatments in all. This patient population is considered “last line,” and the literature suggests cancer progression in this population within a one-to-two month time frame.
Lpath has enrolled 26 patients in the study. ASONEP has a favorable safety profile thus far, with no serious adverse events (SAEs) deemed to be drug-related.
The first 17 patients were initiated at a dose of 15 mg/kg. Of these “lower-dose” patients: 7 had progressive disease at or before the end of four months; 8 were progression-free at the four-month mark (with 1 of these patients deemed a partial responder per Response Evaluation Criteria in Solid Tumors (RECIST) criteria and with 3 of these patients experiencing reduced tumor volume, but not enough to be categorized as a RECIST-based partial responder); and 2 exited the study due to SAEs unrelated to the drug prior to the four-month mark (and are not considered evaluable). Notably, of the 8 patients that were stable or better as of month four, 2 are now in their fifteenth month on the study, 1 is in month thirteen, and 1 is in month ten. An additional patient was stable through month seven, but then missed six treatments during a vacation, and shortly thereafter progressed.
The next 9 patients were initiated at a dose of 24 mg/kg. Of these higher-dose patients: 4 had progressive disease at or before the end of four months; 2 were progression-free at the four-month mark (with 1 of these 2 deemed a partial responder per RECIST criteria); and the remaining 3 have not yet reached their four-month mark.
“A bimodal distribution of patients has emerged, whereby half the patients experience disease progression early, consistent with their “last line” prognosis, while the other half experience stable disease, with a number of them still progression-free beyond one year,” said Dario Paggiarino, M.D., chief development officer of Lpath. “Based on the safety profile and the promising results, we have moved beyond the first cohort of 22 evaluable patients into a second cohort, allowing us to enroll up to a total of 54 evaluable patients.”
“I have been impressed with the preliminary signs of activity that I am observing with ASONEP,” commented Sumanta Pal, M.D., from the City of Hope in Los Angeles, one of the lead investigators in the study. He continued, “The bimodal distribution is promising and supports an extension of the study. Furthermore, ASONEP appears to be well tolerated by the patients, which is not often the case with experimental cancer drugs.”
Extending the study to a second cohort will enable Lpath to confirm the preliminary results seen to date, as well as provide additional data as Lpath explores whether a biomarker could be predictive of activity. In the interim, Lpath will consider studying ASONEP (i) in RCC patients as a first-line or second-line treatment in combination with other drugs and (ii) in patients with other tumor types, either in combination or as a single agent.
This clinical trial of ASONEP has been partially funded by a $3.0 million grant from the National Cancer Institute (NCI) under its Small Business Innovation Research (SBIR) Program.
About Lpath
San Diego-based Lpath, Inc. (NASDAQ: LPTN), an antibody-platform company, is the category leader in lipid-targeted therapeutics. The company’s ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company has developed four drug candidates, two of which—iSONEP for wet AMD and ASONEP for cancer—are currently being investigated in Phase 2 trials. Lpath is also moving towards the clinic with Lpathomab™ for neuropathic pain and neurotrauma and is in the research phase with Altepan™, which is being studied in models of respiratory disease.
SOURCE: Lpath
Post Views: 138
Based on encouraging progression-free survival data, Lpath extends the study to a second cohort and considers additional proof-of-concept studies
SAN DIEGO, CA, USA I July 24, 2014 I Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, reported interim results in a Phase 2a single-arm, open-label trial where ASONEP™ is being investigated as a treatment for metastatic renal cell carcinoma (RCC) in patients that have failed at least one therapy involving a VEGF inhibitor (e.g., Sutent®/ sunitinib maleate) and no more than one mTOR inhibitor (e.g., Afinitor®/everolimus), with a maximum of three failed treatments in all. This patient population is considered “last line,” and the literature suggests cancer progression in this population within a one-to-two month time frame.
Lpath has enrolled 26 patients in the study. ASONEP has a favorable safety profile thus far, with no serious adverse events (SAEs) deemed to be drug-related.
The first 17 patients were initiated at a dose of 15 mg/kg. Of these “lower-dose” patients: 7 had progressive disease at or before the end of four months; 8 were progression-free at the four-month mark (with 1 of these patients deemed a partial responder per Response Evaluation Criteria in Solid Tumors (RECIST) criteria and with 3 of these patients experiencing reduced tumor volume, but not enough to be categorized as a RECIST-based partial responder); and 2 exited the study due to SAEs unrelated to the drug prior to the four-month mark (and are not considered evaluable). Notably, of the 8 patients that were stable or better as of month four, 2 are now in their fifteenth month on the study, 1 is in month thirteen, and 1 is in month ten. An additional patient was stable through month seven, but then missed six treatments during a vacation, and shortly thereafter progressed.
The next 9 patients were initiated at a dose of 24 mg/kg. Of these higher-dose patients: 4 had progressive disease at or before the end of four months; 2 were progression-free at the four-month mark (with 1 of these 2 deemed a partial responder per RECIST criteria); and the remaining 3 have not yet reached their four-month mark.
“A bimodal distribution of patients has emerged, whereby half the patients experience disease progression early, consistent with their “last line” prognosis, while the other half experience stable disease, with a number of them still progression-free beyond one year,” said Dario Paggiarino, M.D., chief development officer of Lpath. “Based on the safety profile and the promising results, we have moved beyond the first cohort of 22 evaluable patients into a second cohort, allowing us to enroll up to a total of 54 evaluable patients.”
“I have been impressed with the preliminary signs of activity that I am observing with ASONEP,” commented Sumanta Pal, M.D., from the City of Hope in Los Angeles, one of the lead investigators in the study. He continued, “The bimodal distribution is promising and supports an extension of the study. Furthermore, ASONEP appears to be well tolerated by the patients, which is not often the case with experimental cancer drugs.”
Extending the study to a second cohort will enable Lpath to confirm the preliminary results seen to date, as well as provide additional data as Lpath explores whether a biomarker could be predictive of activity. In the interim, Lpath will consider studying ASONEP (i) in RCC patients as a first-line or second-line treatment in combination with other drugs and (ii) in patients with other tumor types, either in combination or as a single agent.
This clinical trial of ASONEP has been partially funded by a $3.0 million grant from the National Cancer Institute (NCI) under its Small Business Innovation Research (SBIR) Program.
About Lpath
San Diego-based Lpath, Inc. (NASDAQ: LPTN), an antibody-platform company, is the category leader in lipid-targeted therapeutics. The company’s ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit bioactive lipids that contribute to disease. The company has developed four drug candidates, two of which—iSONEP for wet AMD and ASONEP for cancer—are currently being investigated in Phase 2 trials. Lpath is also moving towards the clinic with Lpathomab™ for neuropathic pain and neurotrauma and is in the research phase with Altepan™, which is being studied in models of respiratory disease.
SOURCE: Lpath
Post Views: 138
