EUSA Pharma Announces 10-Year Outcome Data Demonstrating Utility of Prostascint in Guiding Prostate Cancer Radiotherapy and Improving Disease-Free

LANGHORNE, Pennsylvania and OXFORD, England, Nov. 3 /CNW/ - EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, announced today the publication of 10-year outcome data showing that PROSTASCINT® (capromab pendetide) fusion imaging is an effective tool for targeting and guiding the dosing of prostate cancer radiotherapy. The data also show that PROSTASCINT images can be a significant predictor of disease-free survival. The data are available online in the International Journal of Radiation Oncology Biology Physics, the official journal of the American Society for Radiology and Oncology, prior to publication in the December 2010 issue.

PROSTASCINT is a US FDA approved monoclonal antibody-based radiopharmaceutical imaging agent for use in newly-diagnosed patients with biopsy-proven prostate cancer. It is also used in post-prostatectomy patients where there is a high clinical suspicion of hidden metastatic disease.

"These long-term outcomes data demonstrate the significant benefits PROSTASCINT imaging offers as a tool for defining tumor stage prior to treatment and for enabling image-guided radiotherapy in clinically localized prostate cancer," stated the study's Principal Investigator, Rodney J. Ellis, M.D., Vice-Chairman for Clinical Research and Director of Genito-Urinary Oncology, Brachytherapy, and Advanced Image Guided Radiotherapy at Case Western Reserve University and University Hospitals of Cleveland. "This study reports excellent outcomes when PROSTASCINT is utilized to direct increased radiation doses to regions of the prostate with higher tumor burden, and shows its utility as a predictive tool, identifying patients who may require increased vigilance in post-therapy follow-up, and/or those patients who might benefit from more aggressive treatment, such as adjuvant chemotherapy."

Study Details

The study involved 239 patients presenting for primary radiotherapy with a clinical diagnosis of prostate cancer thought to be confined to the prostate gland. All patients underwent PROSTASCINT SPECT/CT (fusion) imaging prior to radiotherapy. The PROSTASCINT imaging identified 22 patients (9.2%) as suspicious for metastatic disease in the lymph nodes. However, conventional imaging using CT or MRI alone or other staging tools could not confirm these findings.

All patients were treated by low dose brachytherapy using radioactive seeds, and PROSTASCINT fusion images guided dose escalation to regions of higher tumor burden. At 10-year follow up, disease specific survival was 99% when PROSTASCINT fusion imaging defined the tumor as localized, versus 86.4% in patients reported as having metastatic disease in the lymph nodes (p =0.0001) by PROSTASCINT fusion imaging. Despite the significantly different outcome between these two groups, conventional imaging with CT or MRI alone did not identify nodal metastases in any patients prior to treatment. "These highly significant 10-year outcomes data demonstrate that PROSTASCINT fusion imaging can accurately identify otherwise hidden nodal metastases leading to better treatment decisions and therefore better outcomes for patients," said Jim Mitchum, US President of EUSA Pharma Inc.

About Prostate Cancer

Approximately one in six men will develop prostate cancer. According to the American Cancer Society, more than 210,000 new cases of prostate cancer will be diagnosed this year in the United States. Approximately 30,000 men in the US die of prostate cancer annually.

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. 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 US from EUSA Pharma by calling toll free 800-833-3533, or by visiting the web site at http://www.prostascintimaging.com.

About EUSA Pharma

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, oncology supportive care and critical care products. The company currently has eight marketed products*, including Caphoso® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, Collatamp® G, a surgical implant impregnated with the antibiotic gentamicin, ProstaScint® for imaging the extent and spread of prostate cancer and Quadramet® for the treatment of pain in patients whose cancer has spread to the bones. EUSA also has several products in late-stage development.

Founded in 2006, EUSA Pharma is supported by a consortium of leading life science capital investors, comprising Essex Woodlands, 3i, Advent Venture Partners, SV Life Sciences, TVM Capital, NeoMed and NovaQuest. Since its foundation, the company has raised over $300 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. Key to its rapid growth strategy is the company's established commercial infrastructure in the US, pan-European presence covering over 20 countries and wider distribution network in a further 80 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 in its areas of therapeutic and geographic focus.

* Not all products are approved currently for use in the US

For further information:

Jim Mitchum US President EUSA Pharma Inc Tel: +1-215-867-4901

Rob Budge RJB Communications Tel: +44(0)1865-760969 Mobile: +44(0)7710-741241

 

Posted: November 2010

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