Healthcare Industry News: Cytogen
News Release - December 18, 2006
American Cancer Society Journal Article Reports New Data Regarding Repeated Administration of QUADRAMET(R)Study Shows Repeated Dosing of QUADRAMET to Be a Safe and Effective Treatment Option for Patients with Painful Bone Metastases
PRINCETON, N.J.--(HSMN NewsFeed)--Cytogen Corporation (Nasdaq: CYTO ) today reported that new data from a multi-center Phase 4 study evaluating the safety and efficacy of repeated doses of QUADRAMET® (samarium Sm-153 lexidronam injection) in patients with metastatic bone pain was published in the early online view of the American Cancer Society's journal Cancer. QUADRAMET, a targeted radiopharmaceutical, is approved for treating pain from cancer that has spread to the bone. The article, "Safety and efficacy of repeat administration of Samarium Sm-153 lexidronam to patients with metastatic bone pain," by A. Oliver Sartor, M.D., the lead author and a nationally renowned prostate cancer specialist with Dana-Farber Cancer Institute's Lank Center for Genitourinary Oncology, is expected to appear in the February 1, 2007 print issue of the journal.
This is the first prospective clinical trial specifically evaluating the common clinical scenario of patients who initially respond to QUADRAMET and subsequently become candidates for re-treatment upon the recurrence of symptoms. More than 200 patients, including 55 patients who received repeated dosing of QUADRAMET, participated in the study. The results demonstrate that repeated QUADRAMET dosing is a safe and effective treatment option in patients with painful bone metastases.
"Despite a favorable safety and efficacy profile, the routine use of QUADRAMET for the palliation of disseminated painful bone metastases has commonly been reserved for those patients with end-stage disease when other treatment options have been exhausted," said A. Oliver Sartor, M.D., associate professor of medicine, Harvard Medical Schools, Lank Center for Genitourinary Oncology. "Effective pain management improves a patient's quality of life throughout all stages of disease. The results of this study clearly indicate that repeated dosing of QUADRAMET is efficacious, well-tolerated, and a reasonable treatment option for patients with relapsed bone pain."
In the study, which was conducted at 22 institutions in the U.S., Canada and Europe, the 55 patients who were administered multiple doses received a total of 135 administrations of QUADRAMET (mean 2.4 doses/patient, range 2-11). The median interval between the first and second infusions was 140 days; the median interval between infusions after the second was 78 days. The majority of patients had bone metastases secondary to prostate or breast cancer and had received numerous previous treatments. Patients reported their level of pain at baseline and again at weeks four and eight using the Brief Pain Inventory, a validated numeric pain rating scale that has been widely used to evaluate pain in outpatients with cancer. Data were reported for changes in pain scores following the first three administrations.
Consistent decreases in pain scores were observed following each of the first three doses of QUADRAMET, with the magnitude of these changes similar to those observed in prior placebo-controlled studies. The changes from baseline at week four (the prospective primary endpoint in prior placebo-controlled studies) were statistically significant (P less than 0.001) following each of the first three administrations. Both baseline pain scores and decreases following treatment in the study were very close to those reported in prior placebo-controlled studies.
On an individual patient basis, at week four pain scores decreased from baseline in 70%, 63%, and 80% of patients following doses one, two, and three, respectively. The percentage of patients reporting a decrease in pain scores following each of the first three doses was similar to the percentage reported as responders in prior placebo- (65% to 72%) and dose- (70%) controlled studies. Thus, the pain response following multiple administrations of QUADRAMET is similar to that following initial administration both in terms of decrease in pain scores and percentage of patients responding.
Mild, transient suppression of platelets and white blood cells was the most common adverse event following treatment. Nadirs of approximately half of baseline occurred four weeks after dosing with recovery by week eight in 90% of patients following both initial and subsequent administrations. Non-hematologic adverse events were usually related to the patients underlying disease or to the use of concomitant medications, particularly opioid analgesics. The frequency of these events after repeat administrations was similar to or less than that observed after the first.
"The nuclear and biologic properties of prior generation bone targeted radiopharmaceuticals often resulted in myelosuppression characteristics that limit their repeated administration," said William Goeckeler PhD, Cytogen Senior Vice President of Operations. "The data reported in this study are important in demonstrating to physicians that they can administer multiple doses of QUADRAMET to their patients and need not wait until all other treatment options have been exhausted before considering this therapeutic modality. The publication of these results is a part of our continuing execution on multiple key initiatives to position QUADRAMET for future growth and market penetration, including: (i) empowering and marketing to key prescribing audiences; (ii) broadening palliative use within label beyond prostate cancer to include breast, lung and multiple myeloma; (iii) evaluating the role of QUADRAMET in combination with other commonly used oncology agents; and (iv) expanding clinical development to evaluate the potential tumoricidal versus palliative attributes of QUADRAMET."
About Bone Metastases
Each year, more than 100,000 patients in the U.S. develop bone metastases from spread of their primary cancer. Bone is the third most common site of metastatic disease after liver and lung, and spread to bone is associated with considerable morbidity. This includes bone pain and fracture, spinal cord compression, and hypercalcemia. The incidence of bone metastasis is expected to increase over the next decade as patient survival improves due to advances in anticancer therapy. This will make the treatment of this problem more important in the overall management of the surviving cancer patient. The majority of skeletal metastases arise from primary tumors of the thyroid, kidney, lung, prostate, and breast, with the latter two accounting for about 80% of metastatic bone disease. While all bones can be affected, the most common site of disease spread is the spine with the subsequent development of spinal cord compression. In advanced breast cancer, a majority of skeletal events will occur every three to four months resulting in significant morbidity and impaired quality of life.
QUADRAMET is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
QUADRAMET is an oncology product indicated for pain relief that pairs the targeting ability of a small molecule, bone-seeking phosphonate (EDTMP) with the therapeutic potential of radiation (samarium Sm-153). Skeletal invasion by prostate, breast, multiple myeloma, and other cancers often creates an imbalance between the normal process of bone destruction and formation. QUADRAMET selectively targets such sites of imbalance, thereby delivering radioactivity to areas of the skeleton that have been invaded by metastatic tumor.
QUADRAMET has demonstrated a range of characteristics that may be advantageous for the treatment of pain arising from metastatic bone disease, including early onset of pain relief (patients may experience pain relief within the first week with maximal relief generally occurring at three to four weeks after injection), length of pain relief, lasting a median of four months in responding patients, and predictable and reversible bone marrow toxicity or myelosuppression that tends to return to pretreatment levels after eight weeks. QUADRAMET is administered as a single intravenous injection, usually on an outpatient basis, and exhibits selective uptake in areas of bone formation with little or no detectable accumulation in soft tissue.
QUADRAMET Safety Profile
QUADRAMET causes bone marrow suppression. In clinical trials, white blood cell counts and platelet counts decreased to a nadir of approximately 40% to 50% of baseline in 123 (95%) of patients within 3 to 5 weeks after QUADRAMET, and tended to return to pretreatment levels by 8 weeks. Because of the unknown potential for additive effects on bone marrow, QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks. Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function. Non-hematologic adverse events that occurred in 5% or more of patients and greater than placebo were pain flare (7%), diarrhea (6%), infection (7%), spinal cord compression (6.5%), arrhythmias (5%), and hematuria (5%). Patients who receive QUADRAMET should be advised that for several hours following administration, radioactivity will be present in excreted urine. To help protect themselves and others in their environment, precautions need to be taken for 12 hours following administration.
A copy of the full prescribing information for QUADRAMET, 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.
Founded in 1980, Cytogen is a biopharmaceutical company dedicated to advancing the care of cancer patients by building, developing, and commercializing a portfolio of specialty pharmaceutical products. The Company's specialized sales force currently markets QUADRAMET®, PROSTASCINT®, and SOLTAMOX(TM) to the U.S. oncology market. QUADRAMET is approved for the treatment of pain in patients whose cancer has spread to the bone, PROSTASCINT is a PSMA-targeting monoclonal antibody-based agent to image the extent and spread of prostate cancer, and SOLTAMOX is the first liquid hormonal therapy approved in the U.S. for the treatment of breast cancer in adjuvant and metastatic settings. In early 2007, Cytogen plans to introduce its fourth approved oncology product to the U.S. market, CAPHOSOL®, a prescription medical device for the treatment of oral mucositis and dry mouth. The Company is also developing CYT-500, a third-generation radiolabeled antibody to treat prostate cancer. Cytogen's product-focused strategy focuses on attaining sustainable growth through clinical, commercial, and strategic initiatives.
A copy of the full prescribing information for CAPHOSOL, QUADRAMET, PROSTASCINT, and SOLTAMOX, including box warnings, may be obtained in the U.S. from Cytogen Corporation by calling toll free 800-833-3533 or by visiting Cytogen's web site at www.Cytogen.com. The Company's website 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 successfully marketing QUADRAMET; 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. All information in this press release, including 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 this information to reflect subsequent events or circumstances.
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