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Anti-Tumor Activity of Bortezomib in Non-Hodgkin’s Lymphoma Demonstrated in Phase II Trials

SAN DIEGO, Calif., Dec. 8 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced the results of two clinical trials with VELCADE in patients with non-Hodgkin's lymphoma (NHL), in which early signs of anti-tumor activity were observed. These findings from an ongoing phase II investigator initiated study (IIS) and an ongoing phase II National Cancer Institute-sponsored (CTEP) study in patients with various forms of NHL were presented at the 45th Annual Meeting of the American Society of Hematology (ASH) taking place this week in San Diego.

In a study led by Andre Goy, M.D. of the University of Texas M.D. Anderson Cancer Center, 40 patients were evaluated with various types of NHL. Patients were treated with VELCADE and results from this ongoing study include:

-- Overall response rate of 50 percent for 20 of the 22 evaluable patients in the mantle cell lymphoma group. Specifically: * Four had complete responses; * Six had partial responses (including two with major partial responses); and * Two experienced stable disease. -- These patients are still being followed to determine the duration of their response. To date, the median duration of response has been 5.6 months with a range of one to 14 months. -- This patient population was heavily pre-treated, and had received an average of four prior therapies (with a range of one to 12). -- In six out of nine evaluable patients with diffuse large cell lymphoma, one had a partial response. These patients all had relapsed lymphoma who had failed multiple prior therapies. -- One patient who had also failed four prior therapies for Waldenstrom's Macroglobulinemia (a B-cell malignancy) achieved a partial response after two cycles. -- The most common side effects observed in this trial were fatigue, dehydration, and hypotension, which were generally manageable.

"NHL is the most common hematologic cancer and fifth most common cancer diagnosed in the United States each year, and the mortality from NHL continues to increase, hence the need for new therapies," said Dr. Goy. "In these early studies, VELCADE demonstrated promising activity against both indolent and aggressive types of NHL among patients that failed multiple prior therapies; additional studies will be conducted to determine the safety and efficacy of VELCADE against NHL either alone or in combination with other therapies."

In a separate study sponsored by the National Cancer Institute led by Owen A. O'Connor, M.D., Ph.D., Head, Laboratory of Experimental Therapeutics for the Lymphoproliferative Malignancies, Memorial Sloan-Kettering Cancer Center, New York, N.Y., 24 patients with indolent NHL were evaluated. This included nine patients with follicular lymphoma, 10 patients with mantle cell lymphoma, three patients with small cell lymphocytic lymphoma, and two patients with nodal marginal zone lymphoma. Preliminary results of this ongoing study included:

-- Six out of eight evaluable patients with follicular lymphoma experienced major responses: * One patient with a durable complete response; * Five partial responses; and * The median duration of response was six months. -- In nine out of 10 evaluable patients with mantle cell lymphoma: * Five achieved partial responses; * Three experienced stable disease; and * Duration of response has ranged from one to 19 months. * One patient who relapsed 19 months after treatment with VELCADE™ (bortezomib) for Injection was retreated and achieved a second partial response and at three months is still durable. -- Both patients with nodal marginal zone lymphoma achieved a partial response with a duration of response of more than five months; -- All three patients with small lymphocytic lymphoma experienced stable disease with durations observed from between four and six months; and -- Side effects observed were generally manageable and included thrombocytopenia, sensory neuropathy, small vessel necrotizing vasculitis, and lymphopenia.

"VELCADE, with its new and unique mechanism of action, proteasome inhibition, is different from traditional chemotherapies," said David Schenkein, M.D., vice president, clinical oncology development, Millennium. "We are encouraged by these study findings for various subtypes of difficult- to-treat relapsed and refractory lymphomas. We are continuing to study VELCADE alone and in combination against solid and hematologic cancers in multiple ongoing clinical trials."

About Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma is the most common hematological cancer and the fifth leading cause of cancer death in U.S. There are approximately 63,000 new cases diagnosed per year, it is attributed to 27,000 deaths and is the second fastest growing form of cancer in the U.S. According to the American Cancer Society, the incidence of non-Hodgkin's lymphoma has more than doubled since the 1970's. The average age of diagnosis is between 55 and 60.

About VELCADE™ (bortezomib) for Injection

VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma - a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration (FDA) on May 13, 2003 to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival.

VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.

In 228 patients who were treated with VELCADE in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (3 percent) and neutropenia (3 percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pyrexia (7 percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent) and nausea (4 percent).

For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE.

Source: Millennium Pharmaceuticals, Inc.

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