CellAct Pharma's Topoisomerase Inhibitor Demonstrates Success in Phase I Study Involving Adults with Heavily Pretreated Solid Tumors
Nov. 12, 2012
CAP7.1 Showed Acceptable Safety and Tolerability
Initial Signs of Efficacy Observed in Majority of Patients
Data Presented at 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
Phase II Studies in Three Indications Started
DORTMUND, Germany--(BUSINESS WIRE)--CellAct Pharma announced today that the company's product candidate CAP7.1, a modification of the well-established anticancer agent etoposide, showed promising safety and tolerability following administration in adults with heavily pretreated solid tumors. In addition, signs of efficacy of CAP7.1 treatment were observed in the majority of treated patients, thereby indicating overall survival prolongation for patients with cancers of lung, hypopharnyx, ovarian, testicular, stomach, esophageal, biliary tract and neuroendocrine tumor of skin.
Data from this phase I study were presented at the 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland.
"The results from this small study with CAP7.1 are very encouraging. Not only were the safety and tolerability primary objectives achieved, we started to see efficacy responses in therapy-refractory tumors and could achieve the stabilization of such diseases with a monotherapy of CAP7.1 at this advanced disease stage," explained Professor Ulrich Keilholz, Charite Universitätsmedizin, Berlin, the lead investigator on the study. "Some of these tumors are very difficult to treat, especially after being treated with other anticancer agents, so we were very pleasantly surprised as to the extent of response in some patients."
CAP7.1 was administered to 19 patients in four successive dose levels (225-1000 mg/m2/cycle) and displayed manageable side effects (mainly hematological, without organ affection) even at highest dose levels, which represent a nearly threefold increase of the conventional etoposide dose (360 mg/m2/cycle). Interestingly, CAP7.1 shows no hematological toxicities at 360 mg/m2/cycle at all. Non-hematological adverse events were mild or moderate, with the most frequent side effects being nausea, vomiting, fatigue and diarrhea.
14 out of 19 patients showed efficacy signs including stable disease with one patient demonstrating partial response. The progression-free survival of patients strongly correlated with the administered strength of CAP7.1 dose.
"These results with CAP7.1 provide solid basis for further development and so we have initiated phase II studies in three tumor types: biliary cancers, non-small cell and small cell lung cancers," stated Nalân Utku, M.D., Chief Executive Officer of CellAct. "Knowing that CAP7.1 is showing activity against very difficult-to-treat cancers such as gallbladder cancer is heartening. We hope that further clinical studies will confirm and expand on these preliminary data. The results of these trials might lead to a conditional approval and market launch of CAP7.1 already by 2015."
About CellAct Pharma
CellAct Pharma is focused on the development of innovative therapeutics for the treatment of cancers. CellAct's drug candidates target and modulate human molecules that have specific functions in tumor growth. A first small molecule compound, CAP7.1 is currently in a clinical Phase II study for the treatment of solid cancers. CellAct has received a €0.7 million grant from the German ministry for education and science (Bmbf) to support this program. For further information visit www.cellact.eu.