( to confirm the tolerability of this do...)Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity,and Safety Profile of Quadramet at International Myeloma Workshop,Health

-- Overall, there were 15 patients in this expanded cohort who had received a mean 3.4 prior treatment regimens and 10 of the 15 had relapsed following prior treatment with bortezomib. For the entire cohort, the mean neutophil nadir was 1,410/mm(3) and the mean platelet nadir was 108,000/mm(3)

-- The incidence of treatment emergent neuropathy (a side effect commonly observed following bortezomib administration) was low (9%). Two patients with Grade 1 neuropathy at baseline progressed to Grade 2 with one case resolving while on study and a single additional patient experienced Grade 3 neuropathy.

-- Preparations are underway for a follow-up Phase 2 study to further evaluate the efficacy and safety of 1.0 mCi/kg of QUADRAMET and 1.0 mg/m(2) of bortezomib for patients refractory or recently relapsed from bortezomib-containing regimens.

Responses were assessed using Blade criteria, a rigorous assessment standard used to describe changes in disease status, including a confirmation six weeks later. A "complete response" required 100 percent disappearance of M-protein (a marker of tumor burden); negative immunofixation testing; no increase in size or number of lytic bone lesions; and disappearance of soft tissue tumors (plasmacytomas). "Partial" remissions and "minimal" responses represented lesser degrees of response based on the same criteria. Worsening of these indicators constituted "progressive disease".

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 references clinical applications that differ from that reported in the QUADRAMET package insert.

QUADRAMET 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, multip
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