Multiple Myeloma - New Clinical Trial to Evaluate QUADRAMET(R) Combined with Bisphosphonates

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials
Article Date: 11 Jan 2005 - 16:00 PDT

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Cytogen Corporation (Nasdaq: CYTO), a product-driven biopharmaceutical company, today announced that researchers at a leading medical institution have initiated a new clinical trial to evaluate the use of QUADRAMET(R) (samarium Sm-153 lexidronam) in combination with bisphosphonates for the treatment of pain associated with metastatic bone disease in patients with recurrent or refractory multiple myeloma. The escalating dose clinical study will evaluate both the safety profile and effects on painful symptoms and analgesic use. In addition, preliminary information regarding the effect of QUADRAMET on the underlying disease will be determined by monitoring levels of M-protein, a marker for multiple myeloma activity.

(Photo: http://www.newscom.com/cgi-bin/prnh/20041025/PHM011 )

"Current clinical data suggest that a bone targeted approach may represent a potentially useful added component for the treatment of multiple myeloma," said William Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. "This trial represents a preliminary evaluation of the safety when combining QUADRAMET with bisphosphonates and may also provide important preliminary efficacy information. We expect to initiate additional studies throughout 2005 that are designed to systematically evaluate QUADRAMET's potential role as a targeted oncology product in various settings, including both higher dose applications and in combination with a variety of other synergistic agents."

This new clinical trial is based in part on previously reported results from a single arm phase II trial conducted by independent investigators in Europe that evaluated the efficacy of QUADRAMET and zoledronic acid (Zometa(R) by Novartis), a third-generation bisphosphonate, for the treatment of symptomatic refractory elderly multiple myeloma patients. In that study, all eight patients complained of severe, persistent pain, requiring a combination of non-opioid analgesics. Patients were previously treated with pamidronate, a bisphosphonate, with no effect on myeloma or pain control. Patients were asked to quantify their pain using a visual analogue scale (ranked 0-10, with zero representing no pain and ten representing the highest level of pain). At baseline, the median pain rating was 7 (range 7-9). None of the patients were allowed to receive additional treatment during the study. Traditional diagnostic bone scans indicating areas of osteoblastic activity, and uptake of QUADRAMET as evidenced by gamma camera imaging, were equivalent. Treatment consisted of zoledronic acid (4mg) every 28 days, while 2GBq of QUADRAMET was given at enrollment and allowed to be repeated when the disease became symptomatic. After treatment with QUADRAMET and zoledronic acid, the median pain rate was reduced to 2 (range 0-3) with no need for analgesics (p=0.06) at a median follow-up period of 14 months (range 6-19). Interestingly, M-component level, a marker for multiple myeloma activity, decreased more than 25% in 4 out of the 8 patients and was still stable at 19 months follow up.

QUADRAMET is an oncology product that pairs the targeting ability of a small molecule, bone-seeking phosphonate with the therapeutic potential of radiation. Combined, these agents form an innovative molecule with a short radioactive half-life that selectively concentrates in osteoblastic sites (areas of new bone formation). Skeletal invasion by prostate, breast, multiple myeloma, and other cancers often creates an imbalance between the normal process of new bone formation and destruction. QUADRAMET selectively targets such sites of imbalance, thereby delivering radioactivity to areas of the skeleton that have been invaded by metastatic tumor.

Many patients with advanced cancer develop metastatic bone disease, the spread of cancerous cells from the original tumor to bones. It is estimated that 350,000 people die with metastatic bone disease annually in the United States. Pain is one of the most common symptoms associated with metastatic bone disease. Studies have shown that many patients with cancer (especially older adults) do not receive adequate pain relief. Effective pain control can help patients stay involved not only in their cancer treatment but also in the activities of daily living.

QUADRAMET Indication Information

QUADRAMET is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. This press release describes clinical applications that differ from that reported in the QUADRAMET package insert. QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risk. QUADRAMET should not be given after either of these treatments until there has been time for adequate marrow recovery.

A copy of the full prescribing information for QUADRAMET may be obtained in the United States 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.

ABOUT CYTOGEN CORPORATION

Founded in 1980, Cytogen Corporation of Princeton, NJ, is a product-driven biopharmaceutical company that develops and commercializes innovative molecules that can be used to build leading franchises across multiple markets. Cytogen's marketed products include QUADRAMET(R) (samarium Sm-153 lexidronam injection), and PROSTASCINT(R) (capromab pendetide) kit for the preparation of Indium In-111 capromab pendetide in the United States. Cytogen also has exclusive United States marketing rights to COMBIDEX(R) (ferumoxtran- 10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States. COMBIDEX, an investigational molecular imaging agent consisting of iron oxide nanoparticles, is currently being developed for use in conjunction with magnetic resonance imaging to aid in the differentiation of cancerous and non-cancerous lymph nodes, and is under review by the U.S. Food and Drug Administration. Cytogen's development pipeline consists of therapeutics targeting prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells and the neovasculature of many solid tumors. Full prescribing information for the Company's products is available at http://www.cytogen.com or by calling 1-800-833-3533. For more information, please visit the Company's website at http://www.cytogen.com, which is not part of this press release.

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 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.

Cytogen Corporation
Stacy Shearer, Investor Relations, Cytogen Corporation, +1-609-750-8289, sshearer@cytogen.com
http://www.cytogen.com/

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