Cytogen Corporation
(Nasdaq: CYTO) today announced the presentation of data demonstrating the
expression of prostate-specific membrane antigen (PSMA) in cancer of the
kidney. The differential expression of PSMA in renal malignancies was
presented during the 101st American Urological Association Annual Meeting
held May 20-25, 2006, in Atlanta, GA.
In the study, independent investigators at the Cleveland Clinic
evaluated PSMA expression in normal kidneys and tissue samples from both
benign and malignant renal lesions using a tissue microarray. Specimens
from 60 normal kidneys and 99 renal neoplasms of various cell types were
immunostained with the vascular endothelial marker CD34 and an antibody to
PSMA. PSMA expression in tumor-associated neovasculature was tested in
triplicate and scored for staining intensity and percentage of vessels.
PSMA was not expressed in any vascular structures of normal kidneys though
it was detected in the brush border of proximal tubules. In renal
neoplasms, PSMA was only detected in the tumor neovasculature.
"PSMA represents an excellent target for prostate and potentially other
cancers," said Warren D.W. Heston, Ph.D., director, research program in
prostate cancer at The Cleveland Clinic Foundation and one of the authors
of the study. "In addition to being abundantly and preferentially expressed
on the surface of prostate cancer cells, PSMA is also present on
endothelial cells of new blood vessels that supply most other solid tumors.
Our study results demonstrating the expression of PSMA in kidney cancer
justify continued exploration of both imaging and therapeutic approaches
that recognize this unique target."
Differential PSMA staining was noted among the various pathological
types of lesions. PSMA staining was positive in 16 of 21 (76%) clear cell
carcinomas, 5 of 16 (31%) of chromophobe renal cell carcinomas, 0 of 20
papillary renal cell carcinomas, 10 of 19 (53%) oncocytomas, 3 of 14 (21%)
transitional cell carcinomas, and 0 of 19 angiomyolipomas. Only clear cell
carcinoma lesions demonstrated diffuse strong staining while weak or focal
staining was noted in half of the oncocytomas, less than a third of
chromophobe renal cell carcinomas, one fifth of the transitional cell
carcinomas, and none of the specimens of papillary renal carcinoma or
angiomyolipoma. Clear cell carcinoma is the most common type of malignant
renal tumor and oncocytoma is a rare benign lesion.
"This data emphasizes the growing relevance of PSMA as a tumor marker
and suggests that it may have wider application than just prostate cancer,"
noted Michael J. Manyak, M.D., vice president of medical affairs for
Cytogen. "These findings may provide a means to differentiate renal tumors
and also a method to evaluate possible recurrence in patients who undergo
renal ablative procedures or partial nephrectomy for malignancy."
A copy of the following abstract presented at the AUA annual meeting is
currently available on the AUA website at auanet, which is
not part of this press release:
"Expression of Prostate-Specific Membrane Antigen in Tumor-Associated
Vasculatures of Renal Neoplasms" presented on Sunday, May 21 from 1:00 p.m. to 4:00 p.m. during a Poster Session on Kidney and Ureteral Cancer: Basic
Research (Abstract # 382).
About Kidney Cancer
In the United States, kidney cancer accounts for about three percent of
all adult cancers. In 2006, the American Cancer Society estimates that
there will be about 38,890 new cases of kidney cancer in the United States
and that about 12,840 people will die from the disease. Kidney cancer
occurs most often in people between the ages of 55 and 84 and affects men
almost twice as often as women.
About PROSTASCIN
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. By targeting PSMA, the PROSTASCINT molecular
imaging procedure can detect the extent and spread of prostate cancer using
a standard gamma camera.
Cytogen is also developing CYT-500, a therapeutic product candidate
using the same monoclonal antibody from PROSTASCINT combined with a higher
affinity linker to attach a therapeutic as opposed to an imaging
radionuclide. CYT-500 is designed to enable targeted delivery of a
cytotoxic agent to PSMA- expressing cells. Cytogen expects to begin the
first U.S. Phase I clinical trial of CYT-500 in patients with
hormone-refractory prostate cancer during 2006.
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.
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. Clinical
studies have also demonstrated that overexpression of PSMA determined by
immunohistochemical staining using the 7E11.C5.3 antibody 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
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),
PROSTASCINT(R) (capromab pendetide) kit for the preparation of Indium
In-111 capromab pendetide, and SOLTAMOX(TM) (tamoxifen citrate, oral
solution 10mg/5mL) in the United States. Cytogen's development pipeline
consists of CYT-500, a therapeutic radiolabeled antibody targeting
prostate-specific membrane antigen (PSMA), a protein highly expressed on
the surface of prostate cancer cells and the neovasculature of solid
tumors. 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. Full prescribing information for the
Company's products is available at cytogen.
cytogen, 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
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There are a number of important factors that could cause Cytogen's results
to differ materially from those indicated by such forward-looking
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significant risks, which include, but are not limited to: the risk of
obtaining additional capital; the risk of obtaining the necessary
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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
cytogen
auanet
PSMA May Be An Appropriate Target For Both Imaging And Therapeutic Applications In Kidney Cancer
10
03
2016