New Phase III Study Shows Strong Efficacy and Favorable Safety Profile With Single-Agent MabCampath(R) (alemtuzumab) for Patients with Previously Untreated B-CLL

Leeds, England (ots/PRNewswire) -

- Significant Response Rates and Manageable Side Effects Also
Exhibited In Poor-Prognosis and Difficult-to-Treat Patients

According to interim data from a new international Phase III study
called CAM 307, previously untreated patients with progressive B-cell
chronic lymphocytic leukemia (B-CLL) exhibited strong response rates
and a favourable toxicity profile when treated with the monoclonal
antibody MabCampath(R) (alemtuzumab), when compared to patients who
were treated with chlorambucil. The initial results were presented at
the 42nd Annual Meeting of the American Society of Clinical Oncology.

Results from the open-label, randomized trial demonstrated that of
the 297 patients, the overall response rate (ORR) for MabCampath was
83 percent versus 56 percent for chlorambucil (p = less than 0.0001),
which represents a 27 percent greater ORR with MabCampath. The
complete response (CR) was 24 percent for MabCampath versus two
percent for chlorambucil (p = less than 0.0001). Currently,
chlorambucil is considered by many to be the standard front line
therapy for patients with B-CLL.

"This study marks the first time we have been able to examine
MabCampath as a first-line therapy compared to standard chemotherapy,
and we are very encouraged by the results," stated lead investigator
Peter Hillmen, M.D, Ch.B, Consultant Haematologist, Leeds General
Infirmary, Leeds, United Kingdom. "When compared to chlorambucil
treatment, patients with CLL had much higher response rates and with
an acceptable toxicity profile. Furthermore, we encountered promising
response rates in certain difficult to treat patient populations,
particularly those with 11q and 17p deletions."

In an independent review of response, statistically significant
ORR to MabCampath therapy was found in patients with 11q deletions,
common cytogenic abnormalities observed in hematological
malignancies. Patients with 13q deletion, a common genetic event seen
in patients with B-CLL, had a statistically significant CR and ORR to
MabCampath treatment. The IRR also revealed a difference in patients
with 17p deletions, although, due to the lower pool of patients in
this grouping, the difference was not deemed statistically
significant.

Further evaluation of the CAM 307 responders is ongoing and full
results are expected later this year.

About Study Design

The open-label trial randomized 297 patients with previously
untreated, progressive disease requiring treatment at 44 medical
centers in Europe and the United States. Patients were treated with
either 30 mg of MabCampath IV three times per week for a maximum of
12 weeks inclusive of dose escalation periods, or 40 mg/m2 of
chlorambucil PO once every 28 days to a maximum of 12 cycles.

Progression-free survival was the primary endpoint, and secondary
endpoints included safety, overall and complete response rates, and
overall survival.

About CLL

CLL is the most prevalent form of adult leukemia, affecting
approximately 120,000 people in Europe and the United States. The
disease is most commonly diagnosed among people age 50 or older. CLL
is characterized by the accumulation of functionally immature white
blood cells (lymphocytes) in the bone marrow, blood, lymph tissue,
and other organs. Two types of lymphocytes are present in the blood,
B cells and T cells. About 95 percent of CLL cases involve cancerous
B cells. Because these B cells have a longer than normal life span,
they begin to build up and "crowd out" the normal, healthy blood
cells. The accumulation of functionally immature cells in the bone
marrow excludes the generation of healthy cells and can become fatal.
Symptoms include fatigue, bone pain, night sweats, fever, and
decreased appetite and weight loss. Bone marrow involvement also
leads to weakening of the immune system, exposing the patient to a
higher risk of infection.

About MabCampath

MabCampath is the first and only humanized monoclonal antibody
approved for B-CLL therapy and the first product with proven efficacy
in CLL patients who have failed both alkylating agents and Fludara
(fludarabine phosphate) treatment. No other therapy has shown
comparable efficacy in this group of patients. MabCampath has a
completely different mode of action compared with conventional
chemotherapy. By selectively targeting the CD52 antigen, expressed at
higher concentration on malignant lymphocytes, MabCampath activates
cellular processes that lead to the lysis of malignant cell types.
These processes also result in removal of malignant lymphocytes from
the bone marrow, blood, and other affected organs.

Contact:
Greg Moulds
Head of Media Relations
Leeds Teaching Hospitals
+44-113-2066244

ots Originaltext: The Leeds Teaching Hospitals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Greg Moulds, Head of Media Relations, Leeds Teaching Hospitals,
+44-113-2066244