CuraGen, TopoTarget says PXD101 well tolerated, shows potential activity in phase 1 trial

New York, Dec. 12 - CuraGen Corp. and TopoTarget A/S said that phase 1 clinical findings show PXD101 is well tolerated following intravenous administration and has demonstrated potential anti-tumor activity against multiple myeloma, non-Hodgkin's lymphoma and transformed chronic lymphocytic leukemia.

"These results formed the basis for our ongoing phase 2 clinical trial, which is currently evaluating PXD101 for the treatment of advanced multiple myeloma," said Timothy M. Shannon, executive vice president of research and development and chief medical officer at CuraGen, in a news release. "We anticipate that preliminary results from this phase 2 study will be available by mid-2006."

The findings were presented at the annual meeting of the American Society of Hematology in Atlanta.

The phase 1 open-label study was designed to determine the safety, maximum-tolerated dose and potential clinical activity of intravenously administered PXD101. PXD101 was administered as a single agent to patients with advanced hematologic tumors, including multiple myeloma, non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

The drug was generally well-tolerated with the most common adverse events being fatigue, nausea and vomiting, consistent with what has been seen in a larger parallel phase 1 study for patients with solid tumors.

Two patients with multiple myeloma developed an acute decrease in renal function concomitant with decrease in tumor burden, consistent with possible tumor lysis syndrome, an indication of potential clinical activity. In addition, it was reported that one patient with non-Hodgkin's lymphoma had stable disease for five cycles and one patient with transformed chronic lymphocytic leukemia had stable disease for nine cycles.

Preclinical studies with PXD101 were also reported and showed that monotherapy inhibited the growth of various hematological cancer cell lines at sub-micromolar potency and was highly effective even on cell lines that are resistant to other chemotherapeutics. The combination of PXD101 with Velcade (bortezomib) showed greater growth-inhibitory activity, as compared to either drug used alone, on a multiple myeloma cell line.

In a second presentation of preclinical data, PXD101 monotherapy was found to have antiproliferative activity on myeloma cells and to inhibit osteoclast formation. Furthermore, synergistic activity was observed when PXD101 was combined with Velcade in antiproliferative and osteoclast formation in vitro assays, and this drug combination strongly inhibited myeloma tumor growth in an animal model.

CuraGen is a Branford, Conn., biopharmaceutical company. TopoTarget is a Copenhagen, Denmark, biopharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.