Picoplatin for Small Cell Patients Info

[RandyW]

Picoplatin Also Shown to Overcome Platinum Resistance in Preclinical Study -

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 13

/PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced that an analysis of data from its ongoing Phase 1 clinical trial of an oral formulation of picoplatin in patients with solid tumors showed that picoplatin can achieve oral bioavailability of up to 44 percent in doses tested to date. These data are consistent with findings from preclinical oral bioavailability studies of picoplatin. The Company also announced findings from a preclinical study demonstrating that picoplatin retains its activity in small cell lung cancer (SCLC) cell lines made resistant by treatment with cisplatin, carboplatin or oxaliplatin. 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. The data were presented today in a poster session during the Annual Meeting of the American Association for Cancer Research (AACR) in San Diego.

"The data from our ongoing clinical study supports further development of an oral formulation of picoplatin," said Robert De Jager, M.D., chief medical officer of Poniard. "This includes the possible use in combination with other oral cancer therapies and radiation which would provide a novel treatment paradigm for platinum-based cancer therapy."

Additional results from the Phase 1 study presented at the AACR Annual Meeting showed that four weeks after picoplatin dosing -- by either the oral or intravenous route -- only background levels of circulating platinum could be detected, suggesting no drug accumulation between dosing cycles. All doses of the investigational drug were well tolerated. No serious adverse events related to treatment were observed following oral dosing.

In the preclinical study presented at the AACR Annual Meeting, Poniard scientists generated resistant SCLC cell lines by repeatedly exposing the cells to cisplatin, carboplatin, oxaliplatin and picoplatin. They not only found it difficult to obtain picoplatin resistant cells but also found that picoplatin remained effective in SCLC cells previously treated with the other platinum agents.

According to Dr. De Jager, "The data supports the possible use of picoplatin in tumors with acquired platinum resistance resulting from previous treatment with cisplatin, carboplatin or oxaliplatin. The use of platinum-resistant biomarkers may help to identify those patients who would most benefit from picoplatin treatment."

Ongoing Phase 1 Study of Oral Picoplatin

Poniard's randomized, open-label, dose-ranging Phase 1 study is being conducted at clinical sites in the United States. The trial is comparing the bioavailability, pharmacokinetics, pharmacodynamics and safety of picoplatin administered orally with picoplatin administered intravenously in patients with advanced solid tumor malignancies. Bioavailability refers to the fraction of an administered dose of an unchanged drug that reaches systemic circulation. Based on promising findings, Poniard has expanded the study to include additional dose levels to enhance data analysis. The Company expects to present additional data from the trial at scientific meetings this year.

About Picoplatin

Picoplatin is a chemotherapeutic agent that has an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumors. Picoplatin has been evaluated in more than 750 patients and has anti-tumor activity in multiple indications with less severe kidney or nerve toxicity than is commonly observed with other platinum chemotherapy drugs.

Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in SCLC. This registrational trial currently is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint. The Company also is evaluating intravenous picoplatin in two ongoing Phase 2 clinical trials for the treatment of hormone-refractory prostate cancer and metastatic colorectal cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors. The oral formulation of picoplatin has the same active pharmaceutical ingredient as the intravenous formulation. Picoplatin has not been approved by any regulatory authority for use in humans.

[ill_rob]

This is very encouraging. Thank you for posting!

-rob