Navigation Links
High Rates of Pathological Complete Response in Patients with Advanced Esophageal Cancer in OPAXIO™ Phase II Study Reported in American Journal of Clinical Oncology
Date:2/23/2011

SEATTLE, Feb. 23, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that updated phase II study results of OPAXIO (paclitaxel poliglumex) in patients with advanced esophageal cancer conducted by the Brown University Oncology Group were published in the February 3, 2011 issue of the American Journal of Clinical Oncology, Dipetrillo, et al., which demonstrate that 38% (15/40) of the patients receiving OPAXIO in combination with cisplatin and concurrent radiation achieved a pathologic or endoscopic complete response.  A pathological complete response, observed in 32% of patients in the study, is recorded only when the esophagus is surgically removed after therapy and no tumor can be found microscopically.  In historical studies, pathologic complete response has correlated with prolonged survival.

"We are pleased to have the impressive and potentially important results of the paclitaxel poliglumex phase II esophageal study published in a peer reviewed journal," said Dr. Howard Safran, M.D., director of the Brown University Oncology Group.  "In this study, the treatment was well tolerated and we did not see the severe side effects that are typically experienced with standard treatment options.  If these data can be validated in a randomized controlled trial, the use of paclitaxel poliglumex along with cisplatin and radiation could provide an important treatment alternative for patients with lower esophageal cancer with an attractive risk-benefit profile."

The phase II study conducted by the Brown University Oncology Group enrolled 40 patients with pathologically-confirmed, locally-advanced adenocarcinoma or squamous cell carcinoma of the esophagus or gastro-esophageal junction with no evidence of distant metastases.  The patients received weekly paclitaxel poliglumex (50mg/m2) and cisplatin (25mg/m2) for six weeks with concurrent 50.5Gy of radiation. The updated data demonstrated that of the 37 patients who underwent surgery, 12 patients achieved a pathologic complete response.  Additionally, three patients achieved a complete clinical endoscopic response and refused surgery.  Importantly, only one patient required a feeding tube and one patient used total parenteral nutrition. There were no grade 4 hematologic adverse events. Grade 3 hematologic adverse events included neutropenia (6%) and grade 3 non-hematologic toxicities included nausea (7%), esophagitis (7%), and fatigue (5%).

"This phase II study with OPAXIO demonstrated an encouragingly high rate of complete disappearance of cancer in patients that underwent potentially curative surgery following chemoradiotherapy.  Moreover, the therapy had a low incidence of the severe inflammation of the esophagus that frequently requires a feeding tube observed with the current standard regimens," said Jack Singer, M.D., Chief Medical Officer of CTI. "We believe that this study provides preliminary clinical support to our belief that paclitaxel poliglumex is a potent and tumor-selective radiosensitizer."

About OPAXIO™OPAXIO™ (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX™, is an investigational, 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 OPAXIO 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.

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.CellTherapeutics.com.

Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_news.htm

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 and the trading price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of OPAXIO include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with OPAXIO in particular, including, without limitation, the potential for OPAXIO to be proved safe and effective (or to achieve response rates) for the treatment of the indications noted in this press release or any other indication, determinations by regulatory, patent and administrative governmental authorities, the potential that OPAXIO will not produce high rates of complete remission in patients with advanced esophageal or other cancers, that OPAXIO may not be a selective radiosensitizer, that the data described in this press release may not be validated in a randomized controlled trial, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, and costs of developing, producing and selling OPAXIO. You should also review the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.Media Contact:Dan Eramian T: 206.272.4343C: 206.854.1200E: deramian@ctiseattle.comwww.CellTherapeutics.com/press_roomInvestors Contact:Ed BellT: 206.282.7100Lindsey Jesch LoganT: 206.272.4347F: 206.272.4434E: invest@ctiseattle.comwww.CellTherapeutics.com/investors
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cytokine Demonstrates Oral Efficacy of Small-Molecule MIF Inhibitors
2. Lpath Demonstrates Strong Safety Profile of Lead Drug Candidate, Sphingomab(TM), in Non-Human Primates
3. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
4. GlaxoSmithKline Accelerates Review of Exelixis XL880
5. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
6. New Study Presented at WorldSleep 2007 Demonstrates Ramelteon Has Sustained Efficacy Over Six Months in Adults With Chronic Insomnia
7. Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared to Bare Metal Stents in Five-Year Randomized Clinical Trial With No Differences in Long-Term Safety
8. Lpath Demonstrates Preclinical Efficacy of Lpathomab(TM) and Initiates Humanization Process
9. R7128 Demonstrates Safety and Potent Antiviral Activity in HCV-Infected Patients
10. Ortho Biotech Reiterates Confidence in PROCRIT(R) (Epoetin alfa) Safety and Efficacy When Used According to Label
11. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... , April 20, 2017 Research ... America Pharmaceutical Contract Manufacturing Services Market Analysis By Service (Manufacturing, ... Segment Forecasts, 2014 - 2025" report to their offering. ... The Latin American ... 21.0 billion by 2025 Low drug registration cost ...
(Date:4/19/2017)... Cardiology devices segment is anticipated to reach the highest market ... segment is likely to create absolute $ opportunity of a ... By the end of 2027, Cardiology Devices segment is projected ... expanding at a CAGR of 18.4% over the forecast period. ... reprocessed medical devices market in terms of revenue ...
(Date:4/19/2017)... April 19, 2017  IRIDEX Corporation (Nasdaq: ... results for the first quarter 2017 after the close ... management team will host a corresponding conference call beginning ... Investors interested in listening to the conference call ... callers or (703) 326-3030 for international callers, using conference ...
Breaking Medicine Technology:
(Date:4/22/2017)... ... 22, 2017 , ... Ecommerce sales have grown every year since the 1990’s, ... The consequences of rapid innovation and growth are often neglected in the name ... every business and individual’s job to give something back to the planet that provides ...
(Date:4/21/2017)... ... April 21, 2017 , ... An April 10 article ... of ancient teeth, which reveal a great deal about prehistoric ice-age dental practitioners and ... may have been used to remove decayed dental matter, and that teeth were then ...
(Date:4/21/2017)... LAKE CITY, Utah (PRWEB) , ... April 21, ... ... provider of wilderness therapy treatment for adolescents and young adults, has kicked off ... April 20th-Sunday, April 23rd. This year’s theme is “Attachment Informed Therapy for ...
(Date:4/21/2017)... ... 2017 , ... The Patient Advocacy Community of The Beryl Institute presented Eve ... Ravich Patient Advocacy Award in recognition of her extraordinary contributions to the field ... at The Beryl Institute’s annual Patient Experience Conference on March 20 in ...
(Date:4/21/2017)... ... April 21, 2017 , ... Alive for Wellness ... wish to overcome their mental health struggles. The Alive team uses advanced behavioral ... “Our approach in dealing with a mental health struggle is based on 10 ...
Breaking Medicine News(10 mins):