Presented at ASH:
DaunoXome Data Shows Promise in Leukemia, Myeloma; New Data Presented at National Hematology Meeting
MIAMI, Dec. 7 /PRNewswire/ -- Results of 13 Phase I and Phase II trials
published in connection with the annual meeting of the American Society of
Hematology suggest that DaunoXome, a product of NeXstar Pharmaceuticals, Inc.
(Nasdaq: NXTR) holds promise as a potential treatment for a variety of life-
threatening hematological malignancies, including adult and pediatric
leukemias and multiple myeloma.
"Our Phase I/II experience with DaunoXome in hematological malignancies
has demonstrated a positive safety profile and has helped us identify doses
that are well tolerated when administered as a single agent, and in
combination with other anticancer agents commonly used to treat these
illnesses," said Nicole Onetto, M.D., vice president of medical affairs,
NeXstar Pharmaceuticals. "Specifically in leukemia, these results confirm the
anti-leukemic effects of DaunoXome as a single agent in patients with
refractory disease. Also, DaunoXome can be safely associated with Ara-C, one
of the most commonly used agents for the treatment of myeloid leukemias."
Following are summaries of three studies that demonstrated the safety and
effectiveness of DaunoXome in patients with leukemia and multiple myeloma.
Leukemia
"Phase I Trial of Liposomal Daunorubicin (DaunoXome) Administered with
High-Dose Cytarabine (Ara-C) to Patients with Relapsed Acute Leukemia," by
Larry Cripe, of Indiana University Medical Center, Indianapolis, et al.
Treatment for relapsed or refractory acute leukemia is often unsuccessful
due to disease resistance or poor tolerance to therapy. Salvage therapy with
increased dose levels of anthracyclines can be limited by mucosal or cardiac
toxicity. The 18 patients who participated in the study had relapsed acute
leukemia, and had received prior treatment with traditional anthracycline
therapy. Each patient received DaunoXome at doses of 100 mg/m(2) to
250 mg/m(2), in combination with high dose Ara-C. Six of the 18 patients
achieved meaningful responses without evidence of leukemia in the bone marrow;
three of those also displayed complete hematologic recovery. The combination
of DaunoXome and Ara-C was well tolerated. One patient developed significant
mucositis and two experienced minor reductions in cardiac function.
Additional patients will be treated with higher doses of DaunoXome, given on
days one and two.
"High Dose Liposomal Daunorubicin (DNX) and ARA-C for Refractory or
Relapsed Acute Leukemias: A Dose Searching Study," by Jorge Cortes of M.D.
Anderson Cancer Center, Houston, et al.
A previous Phase I study showed that in acute leukemias, DaunoXome was
well tolerated and showed activity against the disease at dose levels of up to
150 mg/m(2) per day. New data presented at this meeting also showed that in
patients with acute leukemia, DaunoXome in combination with Ara-C was well
tolerated and showed anti-leukemic activity. Thirty patients in the study
received DaunoXome, administered at doses of 75 mg/m(2) to 150 mg/m(2) for
three days, together with Ara-C at a dose level of 1 g/m(2)/day for four days.
The median recovery time for neutrophil count was 25 days. The only
significant non-hematological toxicity was mucositis, which was dose limiting
at 150 mg/m(2). Twenty-eight patients were evaluated. Nine of the
25 patients with acute myeloid leukemia (AML) responded, with six achieving
complete remission. Results demonstrate that the recommended Phase II daily
dose of DaunoXome in this combination is 135 mg/m(2) per day.
"Fractionated Cyclophosphamide, Vincristine, Liposomal Daunomycin and
Dexamethasone Regimen (CVXD) is Active in Transformed Chronic Lymphocytic
Leukemia (CLL)," by Frank Giles, M.D. Anderson Cancer Center, Houston, et al.
This pilot study in patients with chronic lymphocytic leukemia, evaluated
the effectiveness of substituting DaunoXome for Adriamycin in a multi-drug
approach to treatment. All patients included in this trial had CLL and had
received prior chemotherapy treatment (one to three lines), including
fludarabine (patients who no longer respond to fludarabine treatment typically
have a poor prognosis). In this abstract, data on nine patients were
summarized. Six of the nine patients achieved a partial response.
Investigators reported that no significant cardiotoxicity was seen with this
therapy combination, and primary toxicity was hematological. Researchers
concluded that combination therapy that includes DaunoXome is effective
against CLL in transformation, and suggest that a larger study is needed for a
complete evaluation. Multiple Myeloma
"Liposomal Daunorubicin is Effective Therapy for Multiple Myeloma," by Ann
Mohrbacher, of the University of Southern California, Los Angeles, et al.
Twenty-three patients with multiple myeloma, and who had previous
chemotherapy treatment, participated in this Phase II trial to assess the
efficacy of DaunoXome, at doses of 100 mg/m(2). Of the 19 patients who were
evaluable, four demonstrated a partial response to treatment and 12
experienced disease stabilization. Neutropenia, a low white-cell count, was
the primary side effect associated with DaunoXome. Researchers conclude that
DaunoXome has activity against multiple myeloma and suggest that further
studies are needed to evaluate this product as a single agent and in
combination therapy.
DaunoXome is a liposomal anticancer product currently indicated as front-
line chemotherapy for advanced HIV-associated Kaposi's sarcoma. Its active
ingredient is the anthracycline daunorubicin, encased in a liposome. Many
patients who participated in these new trials had undergone prior treatment
with daunorubicin.
This press release contains forward-looking statements that involve risks
and uncertainties, and actual events or results may differ materially. While
these statements reflect NeXstar Pharmaceuticals' best current judgment, they
are subject to risks and uncertainties that could cause actual results to vary
from current projections. These risk factors are identified in NeXstar
Pharmaceuticals' reports to the Securities and Exchange Commission filed on
Forms 10-K and 10-Q, and in other SEC filings.
NeXstar Pharmaceuticals Inc. recently announced it will proceed to
separate its existing businesses, creating two independent, publicly-traded
companies. One company, continuing under the NeXstar Pharmaceuticals, Inc.,
will become a specialty pharmaceutical company. This company will focus on
oncology and infectious diseases, leveraging its core liposomal technology,
its unique sales and marketing infrastructure and its drug development
expertise for in-licensing late stage compounds. The other company, to be
named Iterex Technologies, Inc., will further commercialize its proprietary
compound discovery technologies. Iterex will focus on collaborations,
partnerships and licensing agreements with pharmaceutical, biotechnology,
diagnostics, agrochemical and animal health companies.
Note: This release can be obtained from our Internet homepage at
nexstar.com |
