Long-term Outcomes Data Validates the Utility of PROSTASCINT in Guiding Targeted Prostate Cancer Treatment and Predicting Disease Free Survival

Long-term Outcomes Data Validates the Utility of PROSTASCINT in Guiding
Targeted Prostate Cancer Treatment and Predicting Disease Free Survival

LANGHORNE, Pa., Nov. 4 /PRNewswire/ -- EUSA Pharma announced that PROSTASCINT®
(capromab pendetide) fusion imaging was shown to effectively guide prostate
cancer therapy targeting and dosing and is a significant predictor of disease
free survival, according to data presented on Tuesday, November 3, 2009 at the
51st American Society for Therapeutic Radiology and Oncology (ASTRO) annual
meeting in Chicago, Illinois.

An abstract entitled "Long-term outcomes following IGRT for localized prostate
cancer: dose escalation to SPECT/CT determined biologic target volumes and the
bDFS predictive value of capromab pendetide" was presented during podium
session at ASTRO's annual meeting. The abstract describes a 10-year patient
outcomes research project conducted by Dr. Rodney Ellis and colleagues (Case
Western Reserve University and Aultman Hospital ). This research focused on
the use of PROSTASCINT® (capromab pendetide), a monoclonal antibody, linked to
the radioisotope Indium-111 that specifically targets prostate-specific
membrane antigen (PSMA), and is used in the evaluation of patients at risk for
metastatic prostate cancer. The PROSTASCINT images were co-registered or fused
with CT image sets (SPECT/CT). Areas demonstrating increased PROSTASCINT
concentration on these fused image sets defined biologic target volumes which
were used to guide dose escalation to 150% of the prescribed prostate
glandular dose. Patients received additional permanent radioactive seeds in
those areas. Biochemical disease free survival (bDFS) was also evaluated based
on risk group status and on the presence or absence of lymph node metastases
found on the PROSTASCINT image sets at baseline.

Fusion imaging is an in vivo diagnostic technique that combines anatomic and
functional information to provide information that cannot be obtained with
separate imaging modalities alone. Image fusion can combine computed
tomography (CT) or magnetic resonance (MR) with radionuclide imaging using
single-photon emission computed tomography (SPECT) to image an agent such as
PROSTASCINT.

When PROSTASCINT was first introduced to the market, image fusion was not
commonly used in aiding scan results. However, newer fusion imaging
techniques, combined with treatment planning, allow the physician to target
higher doses of radiation to specific areas within the prostate containing
prostate cancer cells -- while keeping radiation levels to important
structures such as the urethra within acceptable limits.

Study Details

The study involved 239 consecutive patients who underwent radio-immunoguided
(PROSTASCINT SPECT/CT) permanent prostate brachytherapy. One hundred and
sixteen patients had low-risk disease (no risk factors), 72 were intermediate
risk (one risk factor), and 51 were high risk (two risk factors). Risk
factors included PSA level equal to or greater than 10, stage equal or greater
than T2b, and Gleason grade equal or greater than 7. Biochemical disease-free
survival (bDFS) was calculated using both the Phoenix and the American Society
for Therapeutic Radiology and Oncology (ASTRO) consensus criteria. The cohort
included 22 patients, all of whom were thought to have a clinical diagnosis of
localized prostate cancer, however had evidence of lymph node involvement on
the SPECT/CT In-111 capromab pendetide images.

The 10 year actuarial analysis by risk groups (RG) showed bDFS to be: 93.5%
for low-risk patients; 86.9% for intermediate risk; and 63.6% for high risk
patients (p = 0.0002). The rate of bDFS for patients having positive SPECT/CT
image findings (indicating metastases) was 65.5% vs. 86.6% for those with
negative image findings (p = 0.0014). Analysis of bDFS by RG subset and
SPECT/CT image findings showed the following using the Phoenix criteria:

Image Positive (%) Image Negative (%) p-value
Low Risk 90.0 93.6 0.4540
Interm Risk 57.1 90.2 0.0055
High Risk 30.0 68.2 0.0520

A significant finding from this long-term follow-up study is that the presence
of metastatic disease in the lymph nodes based on SPECT/CT imaging with
PROSTASCINT In-111 capromab pendetide was found to be an independent and
significant predictor of biochemical failure for the intermediate risk
patients by both bDFS criteria.

"From this long term follow-up study, PROSTASCINT SPECT/CT fusion demonstrated
significant benefit as a tool for pre-treatment staging and image-guided
treatment planning in clinically localized prostate cancer patients," said
principal investigator Rodney J. Ellis, M.D., FACRO. Dr. Ellis is a Radiation
Oncologist at Aultman Hospital, Associate Professor Radiology N.E.O.U.C.O.M.,
and Assistant Professor Urology at CASE School of Medicine. "PROSTASCINT
identified true-localized disease versus previously undetected metastatic
disease, significantly predicting for disease specific survival and freedom
from biochemical failure. We found PROSTASCINT SPECT/CT findings to be
significant for the prediction of biochemical disease free survival in
intermediate-risk patients and high-risk patients. The presence of occult or
previously undetected metastatic disease on SPECT/CT imaging may potentially
benefit patient selection for early and more aggressive therapies or even help
select patients for clinical trials of adjuvant chemotherapy."

About Prostate Cancer

Approximately one in every six men will develop prostate cancer. It is the
most common non-skin cancer among men in America. According to the Prostate
Cancer Foundation, more than 192,000 new cases of prostate cancer will be
diagnosed this year in the United States, and approximately 27,000 men will
die of the disease. It is estimated that there are more than 2 million men
living with prostate cancer in the US.

PROSTASCINT® (capromab pendetide) 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. It is not indicated in
patients who are not at high risk. PROSTASCINT is also indicated in
post-prostatectomy patients with a negative or equivocal standard metastatic
evaluation in whom there is a high clinical suspicion of occult metastatic
disease. PROSTASCINT images should be interpreted only by physicians who have
had specific training in PROSTASCINT image interpretation. Proper patient
preparation is mandatory to obtain optimal images for interpretation (see
PRECAUTIONS, Imaging Precautions in the full prescribing information).
Confirmatory studies should be used in conjunction with PROSTASCINT scan
results to determine appropriate patient management.

This press release describes clinical applications and imaging performance
that differs from that reported in the FDA approved PROSTASCINT package
insert.

A copy of the full prescribing information for PROSTASCINT may be obtained in
the U.S. from EUSA Pharma by calling toll free 800-833-3533, or by visiting
the web site at www.prostascintimaging.com .

About EUSA Pharma Inc.

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical
company focused on in-licensing, developing and marketing late-stage oncology,
pain control and critical care products. The company currently has eight
products on the global market, including Caphosol® (super saturated calcium
phosphate), ProstaScint® (capromab pendetide), Quadramet® (Samarium 153
lexidronam), Erwinase® (Erwinia L-asparaginase for injection) and Kidrolase®
(E.coli L-asparaginase for injection), and the antibiotic surgical implant
Collatamp® G (gentamicin impregnated sponge). EUSA also has several products
in late-stage development, notably Collatamp® G topical, (gentamicin
impregnated collagen sponge) and CollaRx®* (bupivacaine implant).

Founded in 2006, EUSA Pharma is supported by a consortium of leading life
science capital investors, comprising TVM Capital, Essex Woodlands, 3i,
Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and
NovaQuest. Since its foundation, the company has raised over $275 million, and
completed several significant transactions, including the acquisitions of
Cytogen Corporation, Talisker Pharma Limited, the French biopharmaceutical
company OPi SA and the European antibiotic and pain control business of
Innocoll Pharmaceuticals Inc. As part of its rapid growth strategy the company
has an established commercial infrastructure in the US, a pan-European
presence covering over 20 countries and a wider distribution network in a
further 25 territories. EUSA Pharma plans to continue its aggressive program
of acquisitions and in-licensing, in line with its ambitious target to become
the leading specialty company within its specialist areas of medical and
geographic focus.

For more information please visit http://www.eusapharma.com.

*CollaRx® is a registered trademark of Innocoll Technologies Ltd

SOURCE EUSA Pharma (USA), Inc.

Dr. Taheri Mercedes of EUSA Pharma (USA), Inc., +1-215-867-4969,
Taheri.mercedes@eusapharma.com