Five patients experienced SAEs, two of which resulted in death. One patient dosed at 1.8 mg/kg died from multi-organ failure due to acute pancreatitis: while no data suggested this event was drug-related, a possible relationship could not be definitively ruled out. A second patient died 11 days after receiving study drug at 2.8 mg/kg: septic shock was cited as the cause of death. The investigator considered septic shock as probably related and febrile neutropenia as definitely related to PSMA ADC.
PSMA ADC, investigators have reported serious adverse events (SAEs), including three deaths, in a small proportion of patients treated with the drug. Based on data currently available to us, the Company is continuing development of PSMA ADC and has not determined what effects, if any, treatment-related SAEs reported to date or that may be reported in the future may have on the development of PSMA ADC going forward. If, however, we, together with or independently of investigators participating in our clinical trials, or regulators evaluating PSMA ADC were to determine that this candidate cannot safely be administered to patients with sufficient therapeutic effect, we may determine to attempt to reformulate or otherwise change the candidate and/or its administration to alleviate such concerns, which could result in costs and delays that could impair the value of the candidate. If such costs and delays were sufficiently large, we could determine to abandon the PSMA ADC program. Concerns about the safety and/or efficacy of PSMA ADC could also make it more difficult or impossible for us to enter into licensing, collaboration or other arrangements with third parties for further development and commercialization of PSMA ADC. Any of these possibilities could have material adverse effects on Progenics' business, its financial condition, and/or the price of our stock.
These were very sick relapse stage 4 patients, out of options who face near certain death with average life expectancy of a few months to two years. It happens. Relapse patients in clinical trials often die as their disease progresses and the cause is examined. PSMA ADC is well tolerated.
I read the SEC report. The SAEs were also present in the Phase 1 data released a long time ago. Wouldn't we expect SAEs for this group of patients so severely compromised already from the cancer and other types of cancer treatment? I think we need to wait for the data for the much greater number of patients without SAEs who might benefit from PSMA ADC at the end of the month. Also, what about the size of the new group of men being signed up for this drug in December and those who participated in Phase 1 program who want to go on with the treatment. Sounds promising to them. Don't they count. There won't be a magical drug with no serious side effects for these already compromised patients. I read that PGNX is considering having trials for patients who don't have the advanced cancer where the effective dose could be less and therefore less likely to cause SAEs. Also, what about the success PGNX is having with the imaging agent which could be used in combination with radiation like tomotherapy for advanced, metastatic prostate cancer.
Appreciate your comments.
Those deaths were from phase 1 trial! Everybody knew about it,. From the sec filing friday 2 other deaths were mentioned from phase 2 trial. Only one is positively related to the drug due to septic shock. We could give pts antibiotic prophylacticly to protect pts from infection Extension trial pt number is listed as 75 which meant many pts has benefited from the trial.
Approved roche t-dm1 has 3 deaths from early trial.
there is huge difference between those drugs and PSMA ADC
the core difference is when the investigator says the deaths are related to PSMA ADC (the drug) in clinical trial which means if the drug WAS NOT given the person would have lived longer.
Tuesday you will get confirmation of my interpretation from the market if it PGNX tanks. don't tell me because the markets are falling PGNX is following it. if the previous all time high of $6.47 breaks then you know it