PRINCETON, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Cytogen Corporation announced today the presentation of preclinical data for its lead prostate cancer therapeutic product candidate, Lu-177-7E11, at the American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (AACR-NCI-EORTC) International Conference on Molecular Targets and Cancer Therapeutics, the premier international meeting featuring novel cancer therapeutics, on Tuesday, November 15, 2005, starting at 12:30 pm at the Pennsylvania Convention Center in Philadelphia, PA.
A poster presentation titled “Development of Optimal Lu-177 Labeled Monoclonal Antibody (7E11) Constructs for Radioimmunotherapy of Prostate Cancer (abstract #A65)” will feature findings from pharmacokinetic and biodistribution studies of Lu-177-7E11 in mice demonstrating that the antibody-radionuclide linkage of Lu-177-7E11 is stable in serum and successfully accumulates at the tumor site. Acute and expanded acute toxicology studies in rats and dogs, respectively, and safety pharmacology studies in dogs did not reveal any significant adverse reactions with unlabeled doses up to 20 times the anticipated human dose.
“We are encouraged by these preclinical data for our novel radiolabeled monoclonal antibody product candidate,” commented Michael D. Becker, President and Chief Executive Officer of Cytogen Corporation. “Lu-177-7E11 has the potential to be an effective agent for the treatment of prostate cancer and builds on the well established expression of prostate-specific membrane antigen (PSMA) and the effective targeting of this unique antigen with our 7E11 antibody as evidenced by PROSTASCINT(R).”
The company plans to file an investigational new drug application for this product candidate in the first quarter of 2006. Cytogen has exclusive rights to the Lu-177-7E11 product candidate.
ABOUT LU-177-7E11
In April 2005, Cytogen and Dowpharma(SM) contract manufacturing services, a business unit of The Dow Chemical Company, announced a collaboration to create a targeted oncology product designed to treat prostate and other cancers. Dowpharma’s proprietary MeO-DOTA bifunctional chelant technology is being used to attach Lutetium-177 (Lu-177), a therapeutic radioisotope, to the same monoclonal antibody (7E11.C5.3) utilized in Cytogen’s PROSTASCINT (capromab pendetide) molecular imaging agent. This new product candidate uses the targeting capability of the monoclonal antibody to direct and deliver radiation to tumor cells expressing PSMA.
ABOUT PSMA
PSMA is abundantly expressed on the surface of prostate cancer cells. In contrast to other prostate-related antigens such as PSA, prostatic acid phosphatase, and prostate secretory protein, PSMA is a type II integral membrane glycoprotein that is not secreted. PSMA expression is increased 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. This unique expression pattern makes PSMA an excellent antigenic target for monoclonal antibody diagnostic and therapeutic options.
ABOUT CYTOGEN CORPORATION
Founded in 1980, Cytogen Corporation of Princeton, NJ is a biopharmaceutical company that acquires, develops and commercializes 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 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: Jonathan Fassberg of The Trout Group for Cytogen Corporation,+1-212-477-9077 x16
Web site: http://www.cytogen.com/
