>>No, it's not GERN that worries me…. Rather, the collaboration between Cytogen and Progenics<<
roger
>>The intellectual property behind PSMA is so convoluted that it's unfathomable to me and a major reason to doubt the Cytogen-Progenics collaboration will succeed, IMO.<<
Now, I’m confused. Do you consider this program a credible threat to DNDN, or do not? T.i.a.
>> PRINCETON, N.J., April 4 /PRNewswire-FirstCall/ -- Cytogen Corporation (Nasdaq: CYTO - News), a product-driven biopharmaceutical company, today announced a new clinical development initiative for a targeted oncology product designed to treat prostate and other cancers. The product candidate uses DOTA-based bifunctional chelant technology to radiolabel Cytogen's proprietary monoclonal antibody to prostate-specific membrane antigen (PSMA) with a therapeutic radionuclide.
"This new development initiative underscores Cytogen's commitment to the development of novel therapies that target PSMA," said Michael D. Becker, Cytogen's President and Chief Executive Officer. "As evidenced by Cytogen's QUADRAMET® therapeutic product for metastatic bone disease, as well as two marketed products for the treatment of non-Hodgkin's lymphoma and several late-stage product candidates in development, targeted radiotherapy is currently experiencing a renaissance and can be effective in the treatment of various malignancies."
In this new clinical development initiative, DOTA-based bifunctional chelant technology will be used to attach a therapeutic radionuclide to the same murine monoclonal antibody utilized in Cytogen's PROSTASCINT® (capromab pendetide) molecular imaging agent. This antibody, called 7E11-C5.3 (or 7E11), is directed against an intracellular epitope of PSMA. The 7E11 antibody was excluded from the PSMA technology licensed to the PSMA Development Company LLC, the Company's joint venture for PSMA product development. Consequently, the joint venture is not involved in this development initiative.
The epitope of PSMA recognized by the 7E11 antibody is normally found intracellularly, however, malignant tumors often contain cells with abnormally permeable degenerating membranes, which facilitate access of monoclonal antibodies to such targets. This approach has been validated through radioimmunoimaging of prostate cancer with PROSTASCINT. Furthermore, the intracellular epitope of PSMA is less likely to be accessible to the 7E11 antibody in normal tissues that are known to contain low levels of PSMA. Published preclinical studies (J Nuclear Medicine, Vol. 44, pp 610-617, 2003) that compared the biodistribution of 7E11 to several antibodies reported to target epitopes on the extracellular domain of PSMA showed similar uptake in tumor throughout the six days following injection; however, uptake in kidney and small intestine was consistently 30-50% lower for the 7E11 conjugate.
DOTA-based bifunctional chelant technology will be utilized to attach the beta emitting radionuclide lutetium-177 as a payload to the 7E11 antibody, enabling targeted delivery of this cytotoxic agent. The Company intends to develop the resulting innovative molecule for the treatment of various cancers, initially in prostate, that express the PSMA marker.
"We anticipate presenting the results of in vitro and in vivo pre-clinical studies demonstrating that radiotherapy with our PSMA monoclonal antibody is an attractive candidate for development as a potential treatment for prostate and various other cancers at appropriate scientific meetings during 2005," said William Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. "We anticipate filing an investigational new drug (IND) application for the treatment of prostate cancer in the first quarter of 2006."
Cytogen's PROSTASCINT molecular imaging agent is the first and only commercial product targeting PSMA. PROSTASCINT consists of the 7E11 monoclonal antibody directed against PSMA that is linked to the 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 demonstrated that overexpression of PSMA determined by immunohistochemical staining using 7E11 in primary prostate cancer not only correlates with other adverse traditional prognostic factors, but can independently predict disease recurrence.
ABOUT CYTOGEN CORPORATION
Founded in 1980, Cytogen Corporation of Princeton, NJ is a product-driven biopharmaceutical company that develops and commercializes innovative molecules that can be used to build leading franchises. Cytogen's marketed products include QUADRAMET® (samarium Sm-153 lexidronam injection) and PROSTASCINT® (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® (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 many solid tumors. Full prescribing information for the Company's products is available at http://www.cytogen.com or by calling 1-800-833-3533. For more information, please visit the Company's website at http://www.cytogen.com, which is not part of this press release. <<
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