Healthcare Industry News: samarium Sm-153 lexidronam
News Release - September 18, 2006
Combination of High Dose QUADRAMET(R) and Chemotherapy Shows Promise for Treatment of High-Risk Acute Myeloid LeukemiaData published in peer-reviewed journal Leukemia & Lymphoma
PRINCETON, N.J., Sept. 18 (HSMN NewsFeed) -- Cytogen Corporation (Nasdaq: CYTO ) today announced the publication of new data relating to the Company's QUADRAMET® (samarium Sm-153 lexidronam injection) product. The publication, "Marrow irradiation with high-dose 153 Samarium-EDTMP followed by chemotherapy and hematopoietic stem cell infusion for acute myelogenous leukemia" by Vilmarie Rodriguez, M.D., a Pediatric Oncologist at The Mayo Clinic in Rochester, Minnesota, appears in a recent issue of the peer-reviewed journal Leukemia & Lymphoma (Leuk Lymphoma. 2006 Aug;47(8):1583-92).
In the study conducted by independent investigators, four high-risk acute myeloid leukemia (AML) patients (age range 15 to 20 years) received a significantly higher dose of QUADRAMET than the standard palliative dose in combination with chemotherapy conditioning regimens with melphalan (n = 3) or busulfan/cyclophosphamide (n = 1) as preparatory conditioning regimens prior to hematopoietic stem cell transplantation. High-risk features included secondary AML and a chromosomal defect known as monosomy 7 (n = 1), chemotherapy induction failure (n = 1), and AML in relapse (n = 2). The dose of QUADRAMET administered to the patients was 19 mCi/kg (n = 1) and 30 mCi/kg (n = 3), compared to the approved 1 mCi/kg dose used in the palliative setting.
Complete cytogenetic and morphologic remission of AML was seen on follow- up marrow aspirate and biopsy in all patients. Two high-risk AML patients remain in continuous complete remission with excellent quality of life (one patient greater than 2-years, another greater than 4-years) following the treatment regimen with high dose QUADRAMET. Two patients had a complete response and subsequently relapsed (one patient at 64 days and the other at 6 months). No hemorrhagic cystitis, nephrotoxicity, or serious infections were seen.
"The predominant pattern of treatment failure in AML involves incomplete elimination of the disease from the bone marrow," said Dr. Peter Anderson, a Pediatric Oncologist at The University of Texas MD Anderson Cancer Center, an investigator in the study and co-author of the publication. "Because QUADRAMET can provide substantial amounts of radiation specifically to the marrow, the use of this agent in AML may improve the therapeutic index of transplant regimens. The positive clinical responses observed in this group of high-risk patients indicate that further evaluation of this therapeutic approach is warranted."
"The group at the Mayo Clinic has pioneered investigations into the use of high dose QUADRAMET in the treatment of hematologic malignancies including multiple myeloma and AML," said William Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. "These results are exciting not only for the positive clinical responses reported but also because they add to the body of data on the lack of renal and other non-hematologic toxicity associated with the use of these very high doses of QUADRAMET."
About Acute Myeloid Leukemia (AML)
According to the American Cancer Society, acute myeloid leukemia (AML), also known as acute myelocytic leukemia or acute myelogenous leukemia, is a cancer that begins in cells that normally develop into blood cells. "Acute" means that the leukemia develops quickly, and if not treated, would probably be fatal in a few months. Most cases of AML develop from cells that would turn into white blood cells, but some cases of AML develop in other types of blood-forming cells. AML starts in the bone marrow (the soft inner part of the bones), but in most cases it quickly moves into the blood.
About 35,070 new cases of leukemia will be diagnosed in the United States during 2006. Approximately half will be acute leukemias. The most common leukemia is acute myeloid leukemia (AML), with about 11,930 new cases expected. About 9,040 deaths from AML will occur in the United States during 2006. AML is usually treated by a combination of cytotoxic drug therapies and in some cases, bone marrow transplantation.
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 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 www.cytogen.com, which is not part of this press release.
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 www.cytogen.com or by calling 800-833-3533. For more information, please visit the Company's website at 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 or new product indications 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.
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