Jump to content

New PGT306 Protocol to Be Submitted to FDA


Recommended Posts

Cell Therapeutics, Inc. (CTI) Closes PGT305 (PIONEER) Lung Cancer Clinical Trial; New PGT306 Protocol to Be Submitted to FDA by Year End

Thursday December 7, 8:00 pm ET

SEATTLE, Dec. 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC - News) today announced that the Company and the Data Safety Monitoring Board (DSMB) agreed to close the PGT305 PIONEER lung cancer clinical trial and take patients off both treatment arms. CTI's decision was due, in part, to the utility of the current trial given its plans to submit a new protocol to the United States Food and Drug Administration (FDA) and in light of the aberrantly low rate of deaths in the control group. CTI plans to submit a new protocol by the end of the year, under a Special Protocol Assessment, to the (FDA). The new protocol, PGT306, will focus exclusively on women with normal estrogen levels, the subset where XYOTAX has demonstrated the greatest survival advantage in the STELLAR trials.

"While the patients in the PIONEER PGT305 study will not count toward our final pivotal trial results, the data from this trial will be instrumental in helping us understand the unique properties of this biologically enhanced chemotherapeutic and its potential as a gender specific therapy for women with lung cancer and other tumors where estrogen can influence the uptake and metabolism of XYOTAX," said CTI President and CEO, James A. Bianco, M.D.


XYOTAX (paclitaxel poliglumex) is a biologically-enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that XYOTAX is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that XYOTAX metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.cticseattle.com .

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of XYOTAX include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with XYOTAX in particular including, without limitation, the potential failure of XYOTAX to prove safe and effective for treatment of non-small cell lung cancer, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling XYOTAX, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian law, CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward- looking statements whether as a result of new information, future events, or otherwise.


Source: Cell Therapeutics, Inc.

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.