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

Thursday, November 5, 2009 General News
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LANGHORNE, Pa., Nov. 4 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:

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

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

SOURCE EUSA Pharma (USA), Inc.

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