Poniard Pharmaceuticals, Inc. has announced positive preliminary results from its ongoing randomized Phase 2 clinical trial in patients with metastatic colorectal cancer (CRC) and updated results from an ongoing Phase 1 CRC trial.
Preliminary data suggest that picoplatin given in combination with 5-fluorouracil and leucovorin (FOLPI) and oxaliplatin given in combination with 5-fluorouracil and leucovorin (FOLFOX) may have similar anti-tumor activity in metastatic CRC.
The Company will present the Phase 1 and 2 picoplatin data (abstract #4100) in the General Poster Session during the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) at McCormick Place in Chicago.
Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations for the treatment of multiple solid tumor indications.
The randomized, controlled, 100-patient Phase 2 study is comparing the safety and efficacy of intravenous picoplatin given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen with oxaliplatin in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen.
Preliminary data suggest that FOLPI and FOLFOX may have similar anti-tumor activity in metastatic CRC. Preliminary data representing 61 patients will be presented.
Of 11 evaluable patients in the FOLPI arm, 10 achieved disease control (partial response combined with stable disease), including two partial responses.
Of 13 evaluable patients in the FOLFOX arm, 10 achieved disease control, including one partial response. A total of 37 patients across both arms are too early for evaluation.