Pipeline?
From the 10-K
CUDC-101
* In April 2010, we completed a dose escalation phase I clinical trial of this molecule.
25 patients
with advanced, refractory solid tumors
* In August 2010, we initiated a phase Ib expansion trial
50 patients with specific tumor types, including head and neck, non-small cell lung, breast, gastric and liver cancers
38 patients in this trial as of March 3, 2011
((Unusually fast enrollments for US based trials by a small company. Doctors favoring this trial?))
* We also anticipate initiating a phase I clinical trial of CUDC-101 in advanced head and neck cancer patients...during the first half of 2011.
We selected head and neck cancer as our first indication for potential Phase II testing of CUDC-101 for several reasons. First, CUDC-101 demonstrated biological activity on two patients with head and neck cancer in Phase I dose escalation study, including a mixed response in a head and neck cancer patient at 150 mg/m2 dose level and a tumor reduction of over 20% after just four weeks of study drug administration in another head and neck cancer patient at the 275 mg/m2 dosing level. Second, our research team generated strong in vitro and in vivo preclinical data in head and neck cancer, exemplified by data in seven head and neck cancer cell lines that includes some of the highest potency observed of the cell lines in which CUDC-101 was tested. Lastly, we believe that this internal data is supported by published literature demonstrating that both EGFR and Her2 are often implicated in head and neck cancers.
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"exemplified by data in seven head and neck cancer cell lines that includes some of the highest potency observed of the cell lines"
(((Looks like biomarkers have been found, a primary focus for the FDA)))
