PRINCETON, N.J., April 6 /PRNewswire-FirstCall/ -- Cytogen Corporation announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CYT-500, the company’s lead therapeutic candidate targeting prostate-specific membrane antigen (PSMA). Subject to FDA acceptance and Institutional Review Board (IRB) approval at the planned clinical site, Cytogen expects to begin the first U.S. Phase I clinical trial of CYT-500 in patients with hormone- refractory prostate cancer.
CYT-500 incorporates the same monoclonal antibody utilized in Cytogen’s PROSTASCINT(R) (capromab pendetide) molecular imaging agent, but is linked to a therapeutic as opposed to an imaging payload. This novel product candidate is designed to enable targeted delivery of a cytotoxic agent to PSMA- expressing cells. Cytogen retains full and exclusive development rights to CYT-500.
“The submission of this IND for CYT-500 within a year of initiating the development program is a significant step forward for Cytogen as we seek to expand our focus on developing and commercializing a broader range of therapeutic oncology products,” stated Michael D. Becker, president and chief executive officer of Cytogen. “Based upon our experience with PROSTASCINT and demonstrated efficacy with other therapeutic radiolabeled antibodies to PSMA, we feel there is a strong scientific rationale for testing CYT-500 for the treatment of hormone-refractory prostate cancer.”
About Prostate Cancer
Prostate cancer is the most common type of cancer found in American men, other than skin cancer. In 2006, the American Cancer Society estimates that there will be about 234,000 new cases of prostate cancer in the United States and that about 27,000 men will die from the disease. It is estimated that there are more than 2 million American men currently living with prostate cancer.
About PSMA
PSMA is a protein abundantly expressed on the surface of prostate cancer cells, with an increased expression in high-grade cancers, metastatic disease and hormone-refractory prostate cancer. PSMA is also present at high levels on the newly formed blood vessels, or neovasculature, needed for the growth and survival of many solid tumors. In contrast to other prostate-related antigens such as prostate-specific antigen (PSA), prostatic acid phosphatase (PAP) and prostate secretory protein, PSMA is a membrane glycoprotein that is not secreted. These unique attributes make PSMA an excellent target for monoclonal antibody diagnostic and therapeutic options in prostate and potentially other cancers.
About PROSTASCINT
Cytogen’s PROSTASCINT molecular imaging agent is the first and only commercial product targeting PSMA. PROSTASCINT consists of a monoclonal antibody (7E11.C5.3) directed against PSMA that is linked to the imaging radioisotope Indium-111. Due to the selective expression of PSMA, the PROSTASCINT molecular imaging procedure can detect the extent and spread of prostate cancer using a standard gamma camera. Clinical studies have also demonstrated that overexpression of PSMA determined by immunohistochemical staining using 7E11.C5.3 in primary prostate cancer not only correlates with other adverse traditional prognostic factors, but can independently predict disease recurrence.
PROSTASCINT is indicated as a diagnostic imaging agent in newly diagnosed patients with biopsy-proven prostate cancer, thought to be clinically localized after standard diagnostic evaluation and who are thought to be at high risk for pelvic lymph node metastases. PROSTASCINT is also indicated as a diagnostic imaging agent in post-prostatectomy patients with a rising PSA and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease.
A copy of the full prescribing information for PROSTASCINT, including warnings, precautions, adverse events and other safety information, may be obtained in the U.S. from Cytogen Corporation by calling toll-free 800-833-3533 or by visiting the Web site at http://www.cytogen.com, which is not part of this press release.
ABOUT CYTOGEN CORPORATION
Founded in 1980, Cytogen Corporation of Princeton, NJ is a biopharmaceutical company dedicated to improving the lives of patients with cancer by acquiring, developing and commercializing innovative molecules targeting the sites and stages of cancer progression. Cytogen’s marketed products include QUADRAMET(R) (samarium Sm-153 lexidronam injection) and PROSTASCINT(R) (capromab pendetide) kit for the preparation of Indium In-111 capromab pendetide in the United States. Cytogen also has exclusive United States marketing rights to COMBIDEX(R) (ferumoxtran-10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States. Cytogen’s development pipeline consists of therapeutics targeting prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells and the neovasculature of solid tumors. Full prescribing information for the Company’s products is available at http://www.cytogen.com or by calling 800- 833-3533. For more information, please visit the Company’s website at http://www.cytogen.com, which is not part of this press release.
This press release contains certain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and investors are cautioned not to put any undue reliance on any forward-looking statement. There are a number of important factors that could cause Cytogen’s results to differ materially from those indicated by such forward-looking statements. In particular, Cytogen’s business is subject to a number of significant risks, which include, but are not limited to: the risk of obtaining additional capital; the risk of obtaining the necessary regulatory approvals; the risk of whether products result from development activities; the risk of shifts in the regulatory environment affecting sales of Cytogen’s products such as third-party payor reimbursement issues; the risk of failure inherent in the development of therapeutic products based on new technologies; the risk that clinical trials of CYT-500 may not be successful, or that such product will not receive required regulatory clearances or approvals; the risk associated with Cytogen’s dependence on its partners for development of certain projects, as well as other factors expressed from time to time in Cytogen’s periodic filings with the Securities and Exchange Commission (the “SEC”). As a result, this press release should be read in conjunction with Cytogen’s periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and Cytogen undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Cytogen Corporation
CONTACT: Media/Investors contact: Jonathan Fassberg, The Trout Group,+1-212-477-9007 x16, for Cytogen Corporation
Web site: http://www.cytogen.com//
