Pharmaceutical Business review

FDA clears Spectrum’s new drug application

SPI-1620 is being developed as an adjunct to chemotherapy. The highly selective endothelin-B agonist has demonstrated in experimental animal models a transient and selective increase in blood flow to tumors by over 300%, and an increased delivery of anticancer drugs to the tumor while essentially sparing normal tissues and organs, thereby increasing the efficacy and the therapeutic index of these drugs.

“SPI-1620 has shown preclinical evidence of increasing a cancer tumor’s uptake of doxorubicin and other anticancer agents. We believe SPI-1620 could have a broad range of applications as an adjunct to chemotherapy in the treatment of solid tumors,” said Rajesh Shrotriya, president and CEO of Spectrum Pharmaceuticals.

The Phase I trial is an open label, dose-escalation study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with recurrent or progressive carcinoma. The trial is expected to begin enrolling patients once the Investigational Review Boards approve the study.