New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 14, 2013
11:51 EDTPGNXProgenics presents data from Phase 1 study of PSMA ADC
Progenics Pharmaceuticals reported positive clinical data from a completed phase 1 study of PSMA ADC, an antibody-drug conjugate designed to selectively deliver chemotherapy to cells that express prostate-specific membrane antigen. PSMA ADC was generally well tolerated in patients at doses up to and including 2.5 mg/kg, the maximum tolerated dose. Findings were presented at the 2013 Genitourinary Cancers Symposium, a meeting co-sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology. Fifty-two patients with metastatic castration-resistant prostate cancer were dosed at nine dose levels. Significant antitumor activity was observed across doses ranging from 1.8 mg/kg to 2.8 mg/kg. Dose limiting toxicities, primarily neutropenia, were seen at 2.8 mg/kg. The most commonly reported adverse events were anorexia and fatigue. Progenics opened enrollment in a subsequent phase 2 study of PSMA ADC in September 2012. This ongoing trial is an open-label, multicenter study assessing the anti-tumor activity and tolerability of PSMA ADC in up to 75 subjects with mCRPC. Patients are receiving a total of eight doses of drug at 2.5 mg/kg. The study endpoints evaluate responses in prostate specific antigen; circulating tumor cells; pain; and change in tumor size as measured under RECIST criteria. Safety also is being evaluated.
News For PGNX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
February 26, 2015
11:33 EDTPGNXProgenics presents positive Phase 2 data for PSMA ADC
Progenics Pharmaceuticals announced the presentation of the full results from its Phase 2 clinical study of PSMA ADC in patients with metastatic castration-resistant prostate cancer, including new data from the recently completed chemo-nave cohort. The data was presented in a poster session and was also selected for inclusion in the ASCO GU Audio Poster Tour at the American Society of Clinical Oncology Genitourinary Cancers Symposium, taking place from February 26 28, 2015 in Orlando, Florida. "The full data from this trial provides compelling evidence of the anti-cancer properties of PSMA ADC, with both the surrogate biomarker and radiological data suggesting a meaningful clinical benefit in progressive metastatic castration-resistant prostate cancer," stated Daniel Petrylak, M.D., Professor of Medical Oncology at Yale Cancer Center, Clinical Research Program Leader for the Prostate and Urologic Cancers Program at Smilow Cancer Hospital at Yale-New Haven, and lead investigator on the trial. "Although advances in androgen deprivation therapy, or ADT, have provided great benefit to prostate cancer patients, treatment options when ADT fails remain limited, which is why the results for PSMA ADC in this patient population are so encouraging. We observed shrinkage of patients' tumors, the conversion of unfavorable levels of circulating tumor cells to favorable levels and the reduction in patients' PSA scores, all of which provide strong evidence of PSMA ADC anti-tumor activity," said Mark Baker, CEO of Progenics. Baker continued, "This study also demonstrated that our novel anti-tumor agent not only has activity in men previously treated with chemotherapy, but produces a stronger response in men who haven't received prior chemotherapy. In addition, we confirmed that levels of PSMA expression can predict response to our drug and have identified several other possible biomarkers that could serve as companion diagnostics." The Phase 2 trial assessed the anti-tumor activity and tolerability of PSMA ADC, an antibody drug conjugate, in both taxane-experienced and chemo-nave patients that had progressed following treatment with abiraterone and/or enzalutamide. In the chemo-nave cohort, treatment with PSMA ADC reduced tumor size and levels of PSA and CTCs evidencing strong anti-tumor activity. Among these chemo-nave patients, one (3%) had a complete radiological response, four (14%) had a partial radiological response, 22 (76%) showed stable disease, and two (7%) experienced progressive disease. As was observed with the taxane-experienced cohort, the anti-tumor response as measured by PSA and CTCs were generally more prominent in patients with high levels of PSMA expression and low levels of neuroendocrine biomarkers.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use