DALLAS, TX – 31 May 2011 – MENTRIK Biotech, LLC is pleased to announce that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to AME-133v (LY2469298), an anti-CD20 monoclonal antibody, 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.
“We are very committed to aggressively developing AME-133v for follicular lymphoma and other orphan B-cell malignancies,”
According to the Orphan Drug Act of 1983, the orphan drug designation is granted to companies with products aimed at treating rare diseases or conditions that affect fewer than 200,000 Americans. If the company’s product is granted the orphan drug status by the FDA, the company will be eligible to receive various financial incentives, including tax credits, access to grant funding for clinical trials, accelerated FDA review and marketing exclusively after drug approval for a period of as long as seven years.
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’
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.
MENTRIK acquired full rights to develop AME-133v for all human therapeutic, prophylactic, and diagnostic uses from Eli Lilly in January 2011. The company intends to continue the development of AME-133v for the treatment of B-cell lymphomas such as non-Hodgkin’
About MENTRIK Biotech, LLC:
MENTRIK Biotech, located in Dallas, Texas, is a biotechnology company focused on developing novel biologic therapies for the treatment of cancer and auto-immune diseases. MENTRIK is committed to the development of promising drugs to increase the number of treatment options for patients with significant unmet medical needs and to make treatments available to a broader segment of the population.
For more information about MENTRIK Biotech, please visit us at www.mentrik.com or contact us by email at email@example.com or by phone at 214 593.5000.
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