Doxorubicin prodrug INNO-206 cuts tumour size in advanced pancreatic cancer: CytRx

Prodrug reduces side-effects common with anti-cancer drug doxorubicin

INNO-206, a doxorubicin prodrug to treat advanced pancreatic cancer, has been shown to significantly reduce the tumour size in animal studies.

INNO-206 will soon be passing through Phase 2 clinical studies to evaluate its safety and efficacy in patients with advanced pancreatic cancer, announced cytRx.

INNO-206 is a prodrug derivative of the commonly prescribed chemotherapeutic agent doxorubicin.

INNO-206 is designed to reduce adverse events by controlling drug release and preferentially targeting tumors.

In a Phase 1 clinical trial, INNO-206 was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin.

In the Phase 1 clinical trial of 35 patients with various cancers treated with INNO-206, three patients showed a partial tumor reduction and 20 patients showed stable disease over the course of the trial.

Animal studies conducted by INNO-206 inventor Dr. Felix Kratz, Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany, demonstrated statistically significant results in breast, ovarian, pancreatic and small cell lung cancers.

The Phase 2 studies using INNO-206 will be conducted at Tumor Biology Center, Freiburg, Germany as a treatment for patients with advanced pancreatic cancer.

CytRx, which holds the exclusive worldwide rights to INNO-206, will supply INNO-206 for the clinical trial.

CytRx previously announced plans to initiate Phase 2 clinical trials with INNO-206 in patients with advanced soft tissue sarcomas and advanced gastric cancer.

“We are excited about INNO-206 for advanced pancreatic cancer and believe it could become a breakthrough drug not only for the treatment of advanced pancreatic cancer, but also for other solid tumors,” stated Prof Dr Clemens Unger, Medical Director, Clinic for Medical Oncology at the Tumor Biology Center.

The open-label, prospective, multicenter, single-arm Phase 2 clinical trial will enroll up to 15 adult patients with metastatic or inoperative (unresectable ductal) pancreatic cancer who have not been previously treated or have failed gemcitabine therapy, the current chemotherapy standard of care for this cancer.

Trial patients will be treated with intravenously administered INNO-206 once every three weeks for up to six cycles.

Worldwide, pancreatic cancer is the eighth leading cause of cancer death, and it ranks thirteenth in cancer incidence.

Pancreatic cancer is the fourth leading cause of cancer mortality in the US.

The National Cancer Institute estimates that in 2009 more than 42,000 new cases of pancreatic cancer were reported with deaths due to this cancer exceeding 35,000.

The median survival for patients with pancreatic cancer is typically four to six months, with a one-year survival rate of 24% and five-year survival rate of approximately 5%.

CytRx Corporation is a biopharmaceutical research and development company. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a clinical trial for the treatment of acute promyelocytic leukemia (APL).

In addition to INNO-206, CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. CytRx also maintains a 36% equity interest in publicly traded RXi Pharmaceuticals, Inc.