August 12, 2003 Titan’s (AMEX: TTP) Pivanex (AN-9, butyric acid analog) plus the chemotherapeutic agent docetaxel generated a reassuring safety profile in non-small cell lung cancer (NSCLC) patients. In the 12-subject, 4 equal cohort trial presented at the 10th World Conference on Lung Cancer in Vancouver, Pivanex was escalated to optimal dose with 6-hour infusions on three successive days followed by standard dose docetaxel on day 4. Dose-limiting toxicity was not experienced at any dose level, and the combination’s tolerability profile remained reassuring. The rate and severity of neutropenia proved similar to that expected for docetaxel alone. Although not a study powered to evaluate efficacy, 8 of 11 evaluable patients achieved stable disease and 6 remain on treatment.
In June, this dose escalation study prompted Titan to initiate a 225-patient, randomized, controlled clinical trial of Pivanex plus docetaxel in the second-line treatment of advanced NSCLC. The phase IIb investigation will assess whether Pivanex plus docetaxel is of greater clinical benefit than docetaxel alone. Overall survival, time to disease progression, tumor response, and safety are primary objectives of the study.
Pivanex inhibits the class of enzymes known as histone deacetylases that is important for cancer cell growth. Inhibiting histone deacetylases alters expression of multiple genes, promoting cancer cell differentiation and tumor cell death. Histone deacetylase inhibition is not associated with the myelosuppressive effects shared by many chemotherapeutic classes.
In phase II open label studies, Pivanex has already shown monotherapeutic efficacy in advanced NSCLC. Pivanex administration was associated with significant tumor responses and a survival profile comparable to certain cohorts of docetaxel recipients. However, the project’s overall data set to date suggests that its best bet is in combination regimens with contemporary chemotherapy regimens.
Although attention is often focused on novel biotherapies for the treatment of cancer, programs like this one highlight the fact that promising chemotherapy development also continues at a breakneck pace.
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