Endocyte Inc. (NASDAQ: ECYT) announced its exclusive worldwide license of PSMA-617. The biopharmaceutical company is moving quickly to move into Phase 3 of its Lu-PSMA 617 therapy.
Lu-PSMA 617 is a radioligand therapy that specifically targets the prostate membrane antigen. It is present in approximately 80 percent of patients who suffer from metastatic castration-resistant prostate cancer (mCRPC).
Lu-PSMA-617 delivers a radioactive isotope lutetium to tumor cells, while passing by non-PSMA cells. The results showed that it passed through healthy cells safely.
The results showed, Lu-PSMA-617 showed consistent results of PSA (Prostate-specific antigen) response decline in the range of 40 percent to 60 percent in patients. The PSA response rate determines It also showed a RECIST response rate in soft tissue disease between 40 percent to 50 percent. It also showed significant improvement in quality of life and showed reduction of pain rates by 37 percent and 43 percent in patients.
The trial was originally tested among 30 patients, but expanded to 50 percent. The updated results are expected to be announced in 2018.
“Lu-PSMA-617 has the potential to be the first-in-class RLT to address both bone and soft tissue disease, and it is profoundly important to the many patients suffering from mCRPC," said Mike Sherman, president and CEO of Endocyte.
"Despite advances in the last decade that slow the progression of prostate cancer, once metastasized it is nearly always lethal, leading to 300,000 worldwide deaths annually. Lu-PSMA-617 has demonstrated the most compelling activity of any drug currently in development for these post-chemotherapy patients," said Alison Armour, chief medical officer.
“We intend to seek regulatory approval to initiate a Phase 3 registration trial of Lu-PSMA-617 in early 2018. By focusing the company's resources on the execution of this program, we project trial completion as early as 2020." said Sherman.