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GE Healthcare Presents Phase 1 Results on Prostate Imaging Agent at Society of Nuclear Medicine Annual Meeting

-- PHASE 2 PROGRAM UNDERWAY--


News provided by

GE Healthcare

Jun 08, 2010, 06:38 ET

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SALT LAKE CITY, June 8 /PRNewswire/ -- GE Healthcare, a unit of the General Electric Company (NYSE: GE), today will present results of a phase 1 study of anti-[18F]FACBC at the 57th annual meeting of the Society of Nuclear Medicine in Salt Lake City, Utah. The presentation closely follows the launch of the phase 2 clinical development program for anti-[18F]FACBC, which was initially discovered and developed by Emory University, Atlanta, Georgia, and was licensed to Nihon Medi-Physics Co., Ltd. (NMP) of Japan. Anti-[18F]FACBC is under development by GE Healthcare under a sub-license from NMP, which is currently conducting a phase 1 study of the compound in Japan.

Anti-[18F]FACBC is a synthetic amino acid analogue-based PET imaging agent being developed by GE Healthcare as a clinical diagnostic tool. The goal of GE Healthcare's phase 1 program was to test the potential utility of anti-[18F]FACBC at delineating primary prostate tumors, lymph node metastasis, and seminal vesicle involvement. The study included six patients with primary prostate cancer who underwent up to 120 minutes of dynamic positron emission tomography/computed tomography (PET/CT) imaging. Visual and quantitative imaging assessments were performed. Standardized Uptake Value (SUV) analysis of malignant and normal prostate tissue was correlated with standard-of-care imaging and biopsy results.

"Anti-[18F]FACBC  could provide valuable additional information to the physician treating cancer patients like monitoring of early recurrence and playing a role in radiotherapy treatment planning," said Silvia Johansson,  MD, Department of Oncology & Nuclear Medicine, Uppsala University Hospital, Uppsala, Sweden.  "We are particularly excited by anti-[18F]FACBC's potential for providing crucial information that is not available with today's diagnostic tools, a benefit that will ultimately help in improving cancer care."

The anti-[18F]FACBC phase 2 clinical development program was initiated at the end of April 2010 with the launch of study IND 107707.  A total of 80 patients scheduled for prostatectomy will be enrolled at multiple sites in the USA and Europe.

Prostate Cancer

Prostate cancer is the second most common cancer in men after lung cancer.(1) More than 670,000 men are diagnosed with prostate cancer every year. It is estimated the overall incidence in most countries is 8-12 cases per 100,000 people.(2) Around 306,000 cases are diagnosed each year in Europe.(1) In the US, approximately 218,000 new diagnoses are made and of those with prostate cancer approximately 29,000 die per year.(2) Early diagnosis and screening programs for prostate cancer have led to a greater proportion of patients with a low-stage disease at diagnosis.(3) More men are treated with curative intent by radical prostatectomy (RP), external beam radiotherapy, or brachytherapy. However, a substantial percentage of patients still experience a prostate-specific antigen (PSA) relapse within 5 years.(3) Biochemical recurrence is observed in approximately 40% of patients who undergo RP, with 95% of those relapses in the first 5 years.(3)

About GE Healthcare:

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care.  Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost.  In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.  

Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world.  Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE).  Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professional and their patients in more than 100 countries.  For more information about GE Healthcare, visit our website at www.gehealthcare.com.  

About Nihon Medi-Physics Co., Ltd.

Nihon Medi-Physics Co., Ltd. (Head Office: Koto-ku, Tokyo / President: Nobuyoshi Mikami) is a joint venture of Sumitomo Chemical Co., Ltd. (Japan) and GE Healthcare (U.K.) and is a leading radiopharmaceutical manufacturer in Japan. Nihon Medi-Physics has been engaged in development, production, and distribution of radiopharmaceuticals for nuclear medicine procedures that are considered useful in early diagnosis of diseases, and other quality products for diagnostic and therapeutic applications.  Nihon Medi-Physics is determined to make continued efforts for further contribution to the advancement of medical care technologies and improvement of patients' healthcare.

References:

1. Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P. Estimates of the cancer incidence and mortality in Europe in 2006.  Ann Oncol. 2007 ;18(3):581-592.

2. Jemal A, Siegel R, Ward E, et al. Cancer Statistics, 2008. CA Cancer J in Oncol. 2008; 58:71-96. Epub 2008 Feb 20.

3. Lobel B. Does localized prostate cancer exist? Recent Results Cancer Res. 2007; 175: 101-107.

SOURCE GE Healthcare

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