Jump to content

Oral Formulation of Picoplatin


Recommended Posts

Poniard Pharmaceuticals Files Investigational New Drug Application for Oral Formulation of Picoplatin

Tuesday February 13, 8:00 am ET

SOUTH SAN FRANCISCO, Calif., Feb. 13 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD - News), a biopharmaceutical company focused on oncology, today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for an oral formulation of picoplatin. Following FDA review, the Company intends to initiate a Phase 1 clinical trial of oral picoplatin.


"We believe that oral picoplatin has significant potential for use in combination with other oral chemotherapies and targeted therapies, including in a refractory setting following relapse from first-line therapies, due to its convenience and potential to overcome platinum resistance," said Jerry McMahon, Ph.D., chairman, president and CEO of Poniard. "We are excited about the prospect of moving oral picoplatin forward for clinical development, as we believe that the current broad use of platinum-based chemotherapeutics supports both improved intravenous and oral platinum therapies for use in different cancer treatment settings and applications."

In preclinical studies, picoplatin has been shown to have up to 40 percent oral bioavailability and a higher therapeutic index and efficacy against platinum-sensitive and -resistant tumor variants than currently marketed platinum-based therapeutics.

About Picoplatin

Picoplatin, the Company's lead product candidate, is a new generation platinum therapy with an improved safety profile. It is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. Poniard is evaluating intravenous picoplatin in an ongoing Phase 2 clinical trial in small cell lung cancer (SCLC) and in Phase 1/2 clinical trials in colorectal and hormone-refractory prostate cancers. The Company plans to initiate the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of intravenous picoplatin for the treatment of SCLC in the first half of 2007.

Poniard received orphan drug designation from the FDA in November 2005 for picoplatin for the treatment of SCLC and entered into a Special Protocol Assessment (SPA) agreement with the FDA in January 2007 for the SPEAR trial.

Link to comment
Share on other sites

Join the conversation

You can post now and register later. If you have an account, sign in now to post with your account.

Reply to this topic...

×   Pasted as rich text.   Restore formatting

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

  • Create New...

Important Information

By using this site, you agree to our Terms of Use. We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.