Threshold Pharmaceuticals, Inc.(NASDAQ: THLD) today announced that it now expects to report the primary analysis of the TH-302 Phase 2 pancreatic trial in mid- to late February of 2012. It completed enrollment of this trial as scheduled in June 2011 with the enrollment of 214 patients.
Pharmacyclics, Inc (Nasdaq: PCYC), announced today updated results of a Phase 1b/2 trial of PCI-32765 for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The trial included a total of 61 patients with relapsed or refractory CLL/SLL enrolled at two dose levels, 420 mg (n=27) or 840 mg (n=34). The overall response rate (ORR), including PR and CR, for the 420mg dose level was 67% and for the 840 mg dose 68%. The estimated 12 month PFS for the pooled cohorts was 86%. The most common adverse events reported in the trial were Grade 1 (mild) or 2 (moderate) diarrhea, cough, fatigue, and upper respiratory infections. 2 patients discontinued the study treatment due to adverse events.
Endocyte, Inc. (NASDAQ: ECYT), released the results of supplemental analyses of its Phase 2b PRECEDENT trial of EC145 in combination with pegylated liposomal doxorubicin (PLD) in women with platinumresistant ovarian cancer. The results of the trial did not indicate a trend toward benefit in either arm (hazard ratio of 1.099 in the intent-to-treat population). While the median overall survival in the EC145 study arm of 14.1 months represented an improvement in relation to historical trials of PLD alone, the PRECEDENT trial PLD control arm had an overall survival of 16.9 months. The company noted that a factor for this disappointing result was the level of sensitivity to post trial therapy with patients in the control arm receiving post trial treatment at nearly twice the rate of those in the EC145 arm. The primary endpoint was PFS (progression free survival). In FR(++) patients (patients with all folate receptor positive tumors), a 2.5 months improvement in PFS was seen, with PFS of 4 months in EC145 compared with 2.5 months in the control arm resulting in a hazard ratio of 0.465 (p=0.0498). In the FR(+) patient population (patients with a least one tumour positive for the folate receptor), which includes the FR(++) subgroup, the same PFS was evident but with a hazard ratio of 0.652 that was not statistically significant .
Cell Therapeutics, Inc. (NASDAQ: CTIC) said that it intends to initiate a Phase 3 study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) during 2Q 2012.