Emergent BioSolutions to Expand Front Line CLL Clinical Trial of TRU-016 and Rituximab Based on Strong Patient Enrollment and Encouraging Early Clinical Data
ROCKVILLE, Md.--(BUSINESS WIRE)-- Emergent BioSolutions Inc. (NYS: EBS) today announced its decision to expand the protocol for its ongoing Phase 1b, single arm, open label study (Protocol 16009) evaluating the safety and efficacy of TRU-016 in combination with rituximab in previously untreated patients with chronic lymphocytic leukemia (CLL). The expanded protocol will include two new study cohorts to examine a lower dose of TRU-016 with rituximab in front line CLL and to evaluate the combination in relapsed CLL patients. This decision is based on strong patient enrollment along with encouraging early safety and efficacy data from this study. TRU-016 is the company's humanized anti-CD37 monospecific protein therapeutic, built on its ADAPTIRTM (Modular Protein Technology) platform, for the treatment of CLL.
"Emergent is pleased with the progress of our Phase 1b study of TRU-016 in combination with rituximab in front line patients with CLL. The strong enrollment and the encouraging early data from this open label study are expected to facilitate an expanded clinical trial program that would further support the start of Phase 3 clinical trials for TRU-016 in 2014," said Scott C. Stromatt, M.D., senior vice president and chief medical officer of Emergent BioSolutions. "We thank our investigators and all of the patients for the progress thus far and look forward to presenting data later this year."
The company anticipates that this expanded clinical program will significantly enhance the value of TRU-016 and the company's active partnering program without impacting the company's total 2013 operating expenses.
Update on TRU-016 in Combination with Bendamustine (Protocol 16201)
TRU-016 is also currently being evaluated in a randomized, open label, active-controlled Phase 2 study in combination with bendamustine in patients with relapsed CLL. This study is on track to achieve its target enrollment of approximately 60 patients in April 2013. The primary outcome measurement for this study is overall response rate. Results from the Phase 1b portion of this study, presented at the American Society of Hematology annual meeting on December 8, 2012, indicated that TRU-016 in combination with bendamustine was well tolerated and showed an NCI overall response rate of 83% with a CR rate of 33% (n=12). "Data from the combination study with bendamustine are very encouraging," said Dr. Stromatt. "TRU-016 is a unique molecule with a novel target that has shown additive and/or synergistic efficacy in animal models when used in combination with several therapeutic agents used to treat CLL, such as rituximab, ofatumumab, mTOR inhibitor, bendamustine, and PI3K inhibitors."
Data from both TRU-016 clinical trials are expected to be available in the second half of 2013. TRU-016 has received Orphan Drug status from the FDA and Orphan Medicinal Product Designation from the European Commission for the treatment of CLL.
About the ADAPTIR™ Platform
ADAPTIR monospecific proteins are single chain polypeptides that comprise three components: a binding domain (VL and VH), a hinge domain, and an effector domain (huFc). They have a differentiated structure from monoclonal antibodies and can generate a unique signaling response. In addition, ADAPTIR proteins may mediate complement dependent cytotoxicity and Fc dependent cytotoxicity, similar to monoclonal antibodies.
About Emergent BioSolutions
Emergent BioSolutions is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Additional information may be found at www.emergentbiosolutions.com. Follow us on twitter: @emergentbiosolu.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, prospects, plans and objectives of management, and any other statements containing the words "believes", "expects", "anticipates", "intends", "plans", "estimates" and similar expressions, are forward-looking statements. Forward-looking statements in this press release include statements about the possible start of Phase 3 clinical trials of TRU-016, the encouraging data from the Phase 1b study, enrollment in the Phase 2 study (Protocol 16201), and the availability of data from our clinical trials. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the success of our ongoing and planned preclinical studies and clinical trials; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.
Emergent BioSolutions Inc.
Robert G. Burrows, 301-795-1877
Vice President, Investor Relations
Tracey Schmitt, 301-795-1800
Vice President, Corporate Communications
KEYWORDS: United States North America Maryland
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