Celator(R) Pharmaceuticals Announces Positive Phase 2 Results for CPX-1 in Treatment of Colorec...( Results presented at American Society...),Health

Results presented at American Society of Clinical Oncology meeting indicate

CPX-1 improved clinical outcomes compared to historical data.

PRINCETON, N.J., June 3 /PRNewswire/ -- Celator Pharmaceuticals reported positive results from its CPX-1 Phase 2 clinical trial in patients with advanced colorectal cancer. CPX-1 is a liposomal formulation of irinotecan and floxuridine, based on the company's proprietary CombiPlex(TM) technology. The results were presented in a poster presentation at the American Society of Clinical Oncology meeting in Chicago.

The CombiPlex(TM) drug ratio technology platform is a new approach which identifies a ratio of drugs that will deliver a synergistic benefit, locks the desired ratio in a drug delivery vehicle and maintains the ratio in patients with the goal of improving clinical outcomes.

The multi-center, open-label, Phase 2 study had two arms, irinotecan-nave (IRI-naive) and irinotecan-refractory (IRI-refractory). IRI-naive patients had less than or equal to 2 prior regimens; one adjuvant/neoadjuvant and no more than 1 regimen for advanced disease. IRI-refractory patients had disease progression within 6 months of prior irinotecan-containing treatment and started CPX-1 treatment within 12 months of disease progression following irinotecan. Patients received 210 units/m2 of CPX-1 every two weeks.

Twenty-six patients were treated in the IRI-naive arm. The overall response rate (ORR) was 8 percent and the disease control rate (patients who achieved a response or stable disease) was 65 percent. Median progression- free survival (PFS) was 3.9 months. Six patients had a >6 month PFS. These data compare favorably to results published from other studies with irinotecan or an irinotecan-based regimen in this patient population which report an approximate 4 percent response rate and median PFS of 2.5 months.

Thirty-three patients were treated in the IRI-refractory arm. The disease control rate was 45
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