CytRx Corp. (CYTR) Presents Clinical Findings for Aldoxorubicin Trial at ESMO 2012 Congress

CytRx, a biopharmaceutical company that specializes in oncology, yesterday announced favorable data from its Phase 1b/2 clinical trial of its doxorubicin conjugate aldoxorubicin (previously INNO-206), a treatment designed to target and combat tumors. The favorable results from its trial in patients with an advanced form of soft tissue sarcoma was presented at the Sarcoma Poster-Discussion Session (Hall H) at the European Society of Medical Oncology (ESMO) 2012 Congress in Vienna, Austria. Renowned sarcoma specialist, Sant P. Chawla, M.D., Director of the Sarcoma Oncology Center in Santa Monica, CA, led the presentation, entitled “INNO-206 (aldoxorubicin) Is An Active Drug For Relapsed Soft Tissue Sarcoma.”

The aldoxorubicin Phase 1b/2 clinical trial data showed “clinical benefit” (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) for those patients that received the maximum tolerated dose of aldoxorubicin. Of evaluable patients, all of whom suffer from relapsed or refractory soft tissue sarcoma, 10 in 13 (77%) exhibited signs of clinical benefit. The first of this data was presented on June 3, 2012, at the ASCO (American Society of Clinical Oncology) Conference.

Steven A. Kriegsman, CEO and President of CytRx said, “These clinical trial results with aldoxorubicin were introduced at ASCO, presented today at ESMO, and will be featured at the Connective Tissue Oncology Society (CTOS) Conference in Prague, Czech Republic, in November. We believe that the avid reception for presentation of the aldoxorubicin clinical data by leading oncology conferences is a testament to their importance and we are pleased that these clinical results are capturing the attention of the oncology community.”

“Although the trial data are derived from a small patient group, the fact that clinical benefit was seen in 77% of these patients is noteworthy, particularly given the advanced stage of disease,” said the clinical trial’s principal investigator and renowned sarcoma expert Sant P. Chawla, M.D., F.R.A.C.P. “Further, of the eight evaluable patients who were previously treated with doxorubicin and had either not responded or relapsed, five showed clinical benefit with aldoxorubicin. Among these, three showed prolonged partial responses with greater than 30% tumor shrinkage.”

Aldoxorubicin works by combining doxorubicin, a commonly used chemotherapeutic agent, with a proprietary linker technology. Because doxorubicin has an inherent toxicity level, patients are limited to specific doses to protect them from overexposure. However, because the linker technology delivers doxorubicin to tumor sites (where the delivery molecule is cleaved and the doxorubicin is released), the potential exists to increase the drug’s efficacy, while avoiding many of the associated side effects.

CytRx Corporation has plans to meet with the FDA during the second half of 2012 to discuss a potential Phase 3 pivotal trial for patients who have since relapsed or were refractory to chemotherapy.

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