(NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, will hold a conference call to discuss favorable clinical results from the Phase 1b/2 clinical trial with INNO-206 in patients with advanced soft tissue sarcoma and next steps for the INNO-206 program in this indication.
In a press release issued Sunday, June 3, 2012, CytRx reported that clinical benefit defined as partial response and stable disease of at least four months following treatment with up to eight cycles of INNO-206 at the maximum tolerated dose was shown in 10 of 13 (76.9%) of 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, resolved prior to the start of the subsequent treatment cycle, and is also observed with doxorubicin 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.