Healthcare Industry News: ferumoxytol
News Release - June 8, 2006
Cytogen and Philips Demonstrate PROSTASCINT(R) Image Acquisition and Processing Tools That Improve Efficiency and Reduce Imaging TimeNew technologies reported at Society of Nuclear Medicine annual meeting aimed to pace the future of PROSTASCINT imaging, data suggest use of advanced image processing tools could significantly shorten acquisition times without compromising image quality
PRINCETON, N.J., June 8 (HSMN NewsFeed) -- Cytogen Corporation (Nasdaq: CYTO ) and Royal Philips Electronics (NYSE: PHG; AEX: PHI) today announced the presentation of data demonstrating significantly improved resolution and quality of PROSTASCINT® (capromab pendetide) images through the application of Philips' unique Astonish image processing tools. Results were presented at the 53rd Society of Nuclear Medicine (SNM) annual meeting in San Diego, CA on June 5, 2006.
"The advanced image resolution recovery techniques provided by PROSTASCINT utilizing the Philips Astonish image processing technology allow physicians to visualize in greater detail the location and extent of disease, from both an anatomical and physiological perspective," said Michael Haseman, M.D., Nuclear Medicine physician with Radiological Associates of Sacramento in Sacramento, California one of the authors of the study. "These advances have the potential to simultaneously increase productivity for physicians and benefit patients by decreasing the amount of time for acquisition of a PROSTASCINT image."
Philips offers highly advanced SPECT detector technology, acquisition techniques and reconstruction algorithms, including concurrent imaging, energy independent detector design and Astonish 3-D reconstruction. This patented imaging technology provides exceptional image resolution for single-photon emission computed tomography (SPECT) and novel molecular imaging agents, such as PROSTASCINT.
"These new technologies create a true breakthrough in terms of SPECT imaging, and we're excited to see clinical improvements being realized at leading hospitals with our products," said Ian Farmer, senior vice president, nuclear medicine, for Philips Medical Systems. "In addition to high quality, high resolution images, the system provides hospitals and research facilities with a competitive advantage for today's procedures and a sound investment for future molecular imaging applications."
SNM abstract #1436 titled "PROSTASCINT SPECT image quality is significantly improved by implementation of 3D OSEM with resolution recovery and attenuation and scatter correction."
The objective of this study was to determine if PROSTASCINT image quality can be significantly improved by applying resolution recovery techniques while simultaneously reducing image acquisition times. PROSTASCINT studies were obtained on twelve consecutive patients using a dual-head Philips SKYLight camera. Images were processed using filtered back projection (FBP), standard 3D-OSEM, and with Philips' Astonish software. The Astonish software implements a matched filtering technique to control noise, even when iterating enough to recover image features that are not obvious with standard processing. The full, three quarter and half count image sets reconstructed with Astonish software were compared to the full count images processed with FBP and 3D-OSEM. In three patients who also had pelvic CT scans, the CT data sets were used to generate attenuation maps and attenuation correction (AC) and scatter correction (SC) were applied.
On subjective evaluation, Astonish processing significantly improves the resolution and quality of PROSTASCINT SPECT images. CT attenuation and scatter correction provide further improvement. Astonish-processed images using half the total number of counts appeared superior to images processed with FBP and images using 75% of the counts were superior to images processed with 3D-OSEM. These findings suggest use of Astonish processing would make it possible to significantly shorten acquisition times without compromising image quality.
"This data presented at the SNM meeting adds to the growing body of peer reviewed clinical literature and presentations at major medical meetings reporting the clinical utility and positive outcomes associated with advanced PROSTASCINT imaging," commented Michael D. Becker, president and chief executive officer of Cytogen.
About Prostate Cancer
Prostate cancer is the most common type of cancer found in American men, other than skin cancer. In 2006, the American Cancer Society estimates that there will be about 234,000 new cases of prostate cancer in the United States and that about 27,000 men will die from the disease. It is estimated that there are more than 2 million American men currently living with prostate cancer. Tests to determine the amount of prostate-specific antigen (PSA), a protein produced by the cells of the prostate gland, in the blood along with a digital rectal exam is used to help initially detect prostate cancer and is also used to monitor patients with a history of prostate cancer to see if the cancer has come back, or recurred. PSA levels cannot directly identify the extent or location of disease.
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 by calling toll-free 800-833- 3533 or by visiting the Web site at http://www.cytogen.com, which is not part of this press release.
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® (samarium Sm-153 lexidronam injection), PROSTASCINT® (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® (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 http://www.cytogen.com or by calling 800-833-3533. For more information, please visit the Company's website at http://www.cytogen.com, which is not part of this press release.
ABOUT ROYAL PHILIPS ELECTRONICS
Royal Philips Electronics of the Netherlands (NYSE: PHG, AEX: PHI) is one of the world's biggest electronics companies and Europe's largest, with sales of $37.7 billion (EUR 30.4 billion) in 2005. With activities in the three interlocking domains of healthcare, lifestyle and technology and 161,500 employees in more than 60 countries, it has market leadership positions in medical diagnostic imaging and patient monitoring, color television sets, electric shavers, lighting and silicon system solutions. News from Philips is located at http://www.philips.com/newscenter.
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 press release regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and investors are cautioned not to put any undue reliance on any forward-looking statement. There are a number of important factors that could cause Cytogen's results to differ materially from those indicated by such forward-looking statements. In particular, Cytogen's business is subject to a number of significant risks, which include, but are not limited to: the risk of obtaining additional capital; the risk of obtaining the necessary regulatory approvals; the risk of whether products result from development 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.
Source: Royal Philips Electronics
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