(NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, announces that favorable clinical results from its Phase 1b/2 clinical trial with its tumor-targeting doxorubicin conjugate INNO-206 in patients with advanced solid tumors, primarily soft tissue sarcomas, are being presented today at the American Society of Clinical Oncology (ASCO) conference in Chicago. All patients in the study had either not responded to or relapsed after treatment with between one and three prior chemotherapy regimens.
Clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) with INNO-206 at the maximum tolerated dose was shown in 10 of 13 (76.9%) evaluable patients with relapsed or refractory soft tissue sarcoma.
In addition, best response for the 13 evaluable soft tissue sarcoma trial subjects included the following:
- Five (38.5%) achieved partial response, as defined as tumor shrinkage of more than 30%
- Seven (53.8%) showed prolonged stable disease (defined as tumor shrinkage <30% from baseline or tumor growth <20% from the nadir)
- Eight (61.5%) had tumor shrinkage
- Five of eight patients (62.5%) who demonstrated either partial responses or prolonged stable disease after treatment with INNO-206 had been previously treated with doxorubicin and had failed to respond.
There were no observed cardiac toxicities and no drug-related patient deaths. The most common adverse event, neutropenia, also observed with doxorubicin treatment, resolved prior to the start of the next treatment.
Median estimated progression-free survival for advanced soft tissue sarcoma patients in the trial was 6.4 months with a range of 1.0 to more than 10.7 months. This compares favorably with the historical median progression-free survival for this patient population of approximately 3 months.
The presentation at ASCO was made by the trial’s principal investigator Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif. Dr. Chawla is a world-renowned expert in soft tissue sarcoma treatment who has evaluated most chemotherapies being tested in this indication. The poster, entitled “Phase 1b/2 Study of INNO-206 (EMCH-doxorubicin) in Patients with Soft Tissue Sarcoma,” was authored by Dr. Chawla, Victoria S. Chua, Andrew Hendifar, M.D., Doris Quon and Sandeep Nagre of the Sarcoma Oncology Center; Kristen N. Ganjoo, M.D. of Stanford University; Kamalesh Sankhala, M.D. of the University of Texas Health Science Center; and Scott Wieland, Ph.D. and Daniel Levitt, M.D., Ph.D. of CytRx.