Another CD20 Drug gets Orphan Designation, but for Follicular Lymphoma

[Guest guest]

MENTRIK Biotech's Antibody AME-133v Granted Orphan Drug Designation for

Follicular Lymphoma

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Jun 01, 2011 – MENTRIK Biotech LLC's Anti-CD20 Antibody,

AME-133v, is Granted Orphan Drug Designation for the Treatment of Follicular

Lymphoma

AME-133v is a fully humanized high-affinity immunoglobulin G subclass (IgG1)

anti-CD20 monoclonal antibody for which Phase I/II clinical trials for

follicular lymphoma and rheumatoid arthritis have been completed. AME-133v has

been optimized through protein engineering both for increased affinity for CD20

and increased effector function in antibody-dependent cell-mediated cytotoxicity

(ADCC), which may lead to superior efficacy and safety.

About AME-133v (LY2469298)

AME-133v is a fully humanized, Fc-engineered, antibody and has been optimized

through protein engineering both for increased affinity for CD20 and increased

effector function in antibody-dependent cell-mediated cytotoxicity (ADCC), which

may lead to superior efficacy and safety.

The CD20 antigen is a validated target for the treatment of patients with B-cell

cancers like lymphoma, chronic lymphocytic leukemia (CLL), and for auto-immune

diseases like rheumatoid arthritis (RA). Rituximab (Rituxan®), a

first-generation human-mouse chimeric antibody has been approved by the FDA for

the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and

rheumatoid arthritis.

A Phase I/II clinical trial with AME-133v for the treatment of patients with

previously treated follicular lymphoma has been completed. Sixty-seven patients

were treated with AME-133v in this trial. The results showed that AME-133v is

well tolerated and 375 mg/m² was confirmed as the recommended dose for future

trials.