Combination of QUADRAMET(R) and Novel First-in-class Proteasome Inhibitor to be Evaluated in New Clinical Trial
Monday November 28, 6:00 am ET
Multicenter Phase I Trial Will Enroll Patients with Multiple Myeloma
PRINCETON, N.J., Nov. 28 /PRNewswire-FirstCall/ -- Cytogen Corporation (Nasdaq: CYTO - News) today announced the initiation of a multicenter Phase I clinical trial to investigate the use of QUADRAMET® (samarium Sm-153 lexidronam) in combination with bortezomib (Velcade®, Millennium Pharmaceuticals, Inc.) for the treatment of multiple myeloma. The clinical study will evaluate the safety profile and preliminary incidence and duration of clinical benefits of bortezomib in combination with QUADRAMET.
The principal investigator for this new study, which has received Institutional Review Board (IRB) approval, is James Berenson M.D., a medical oncologist who previously served as the Director of the Multiple Myeloma and Bone Metastasis Programs at the Cedars-Sinai Medical Center and Professor of Medicine in Hematology/Oncology at the UCLA School of Medicine.
"Current clinical and preclinical data suggest that a bone-targeted approach may represent a potentially useful added component for the treatment of multiple myeloma," commented Dr. Berenson. "This trial represents a preliminary evaluation of the safety when combining QUADRAMET with bortezomib and may also provide important preliminary efficacy information."
The study is being conducted at 4-6 centers of excellence in myeloma therapy across the United States. It is anticipated that up to 36 patients will be enrolled in the study.
"We are encouraged by the positive preclinical data scheduled for presentation at the upcoming American Society of Hematology annual meeting on the combination use of QUADRAMET and bortezomib," said William Goeckeler, Ph.D., Senior Vice President of Operations at Cytogen. "This new clinical study represents another step forward as we continue to pursue new opportunities to evaluate QUADRAMET's potential role as a targeted oncology product in a wide range of cancers. We will also continue to advance research underway studying QUADRAMET in higher dose applications and in combinations with chemotherapeutics, biologics, and other potentially synergistic agents."
About QUADRAMET
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 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 many characteristics that the company believes are 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), predictable and reversible bone marrow toxicity or myelosuppression, ease of administration, and length of pain relief, lasting an average of four months in responding patients. QUADRAMET is administered as a single intravenous injection, usually on an outpatient basis, and exhibits selective uptake in bone 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 plain 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. |
