New reports on picoplatin from Poniard
US-based Poniard Pharmaceuticals has presented encouraging safety data from a Phase I dose-escalation study of picoplatin for the treatment of colorectal cancer.
The data presented at the 2008 Gastrointestinal Cancers Symposium included safety data from a Phase I study of picoplatin in combination with 5-fluorouracil (5FU) and leucovorin (LV) as a first-line treatment for metastatic colorectal cancer (mCRC). The Phase I study seeks to establish the maximum tolerated dose of picoplatin and provide information on the safety of picoplatin when combined with 5FU and LV.
Jerry McMahon, chairman and CEO of Poniard, said: “These study results suggest that picoplatin does not cause severe neurotoxicity, as is commonly seen in mCRC patients treated with the regimen of 5FU and LV with oxaliplatin. Picoplatin has demonstrated both good tolerability and no severe neuropathies when combined with 5FU and LV. We believe picoplatin has the potential to be a preferred platinum for the treatment of colorectal and other cancer indications.”
Picoplatin
Picoplatin is a cytotoxic platinum compound in clinical development for the treatment of patients with solid tumors. It causes apoptosis (cell death) by binding to DNA and interfering with DNA replication and transcription.
Picoplatin is a new generation platinum chemotherapy agent that has an improved safety profile compared to existing platinum-based chemotherapeutics and was designed to overcome platinum resistance. Picoplatin has been evaluated in more than 750 patients and has demonstrated activity in multiple indications with no evidence of significant kidney, nerve toxicity or hearing loss.
Potential Benefits
Platinum drugs destroy cancer cells by binding to DNA. This causes damage that triggers apoptosis (programmed cell death) if the damage is too severe to be repaired by intracellular systems.
However, currently available platinum therapies have significant shortcomings, including toxicities and drug resistance (both intrinsic and acquired) that limit their use.
Picoplatin, which was designed to overcome platinum resistance associated with the treatment of solid tumors, has several potential benefits:
- Broadly applicable for treatment of solid tumors
- Demonstrated mechanism for use with new therapies
- May provide safer alternative to existing platinums
- Addresses unmet medical need by treating platinum-sensitive, -resistant and -refractory disease
- Large and growing market for platinum products
Poniard gets Fast Track designation for lung cancer treatment
Poniard Pharmaceuticals has been granted Fast Track status by the FDA for its lead product candidate, picoplatin, for the second-line treatment of refractory or resistant small cell lung cancer.
Picoplatin is currently being studied in the pivotal Phase III SPEAR (study of picoplatin efficacy after relapse) trial in small cell lung cancer (SCLC), which is evaluating overall survival as the primary endpoint and is being conducted under a special protocol assessment agreement with the FDA.
Poniard’s updated data from its Phase II SCLC trial confirmed and extended a median overall survival of 27 weeks (based on an analysis of 63 patients), which compares favorably to a median survival of approximately 17 to 22 weeks for patients who receive other second-line chemotherapy, according to the 2007 national comprehensive cancer network practice guidelines.
“Our receipt of Fast Track designation has the potential to accelerate the development of picoplatin for the treatment of small cell lung cancer, a difficult-to-treat disease, and a patient population with very limited treatment options,” said Jerry McMahon, chairman and CEO of Poniard.
“We are focused on executing our ongoing Phase III SPEAR trial to facilitate the expeditious filing of a new drug application and obtaining the approvals required to make picoplatin available to this severely underserved patient population.”