RE:RE:RE:ONCY Presented Positive GOBLET Pancreatic Cancer Data @ ESMOAs a further follow-up on the information presented - it is necessary to understnd that an adaptive Phase 2 cliniclal trial for a drug that is then granted a FDA Accelerated Approval, as early as during the process of the patient enrollment stage, becomes a confirmatory trial /.post-marketing approval Phase 4 clinical study - without the need to file a Phase 3 clinical trial.
This is especially true for biological drugs which address orphan/ rare diseases with unmet medical treatment needs, which is applicable to ONCY's pelareorep. The Accelerated Approval process saves the sponsoring company both time and money in getting their drug into the market and to patients in need of the treatment.
This notwithstanding, ONCY has 5 indications that appear to be Phase 3 ready clinical trials.
These 5 indications with pelareorep include:
(1) HR+/HER2 negative metastatic breast cancer;
(2) Triple Negative Breast Cancer (TNBC);
(3) pancreatic cancer with pelareorep + ICI + n-paclitaxel;
(4) pancreatic cancer with pelareorep + ICI + folfirinox, and;
(5) anal (SCCA) cancers.
Furthermore, ONCY has recently demonstrated that pelareorep can be effective as a single dose in the treatment of Hepatocellular carcinoma cancer (HCC).