Archive for September 2011
Emergent Announces Initiation of a Phase 1b/2 Study of TRU-016 in Combination with Rituximab and Bendamustine in Subjects with Relapsed – Indolent Lymphoma
Posted September 30, 2011on:
ROCKVILLE, Md., Aug 17, 2011 –
Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 1b/2 study (16011) of TRU-016 in combination with rituximab andbendamustine for patients with relapsed indolent non-Hodgkin’s B-cell lymphomas, including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma. TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical(TM) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.
“Although patients show a high rate of clinical response to first line therapies they often relapse and in many cases, develop a resistance to treatment,” said Dr. Scott Stromatt, Vice President of Clinical Research and Chief Medical Officer at Emergent BioSolutions. “Our preclinical studies show that when used together, TRU-016 and bendamustine resulted in increased anti-tumor activity beyond results achieved when either drug was administered alone. TRU-016 is also synergistic with rituximab in preclinical models. Based on these data, as well as data from our ongoing clinical studies of TRU-016 for chronic lymphocytic leukemia, we believe that TRU-016 in combination with bendamustine and rituximab could produce meaningful results in patients with indolent NHL.”
The Phase 1b portion is a dose escalation study to determine the Phase 2 dose of TRU-016 given in combination with rituximab and bendamustine. In this portion of the trial, up to 12 patients will receive two dose levels of TRU-016 in combination with rituximab and bendamustine administered intravenously. The primary safety endpoint for the Phase 1b portion of the study is the incidence of dose-limiting toxicities (DLTs).
The Phase 2 portion will be an expansion study of approximately 76 additional patients to examine the safety and efficacy of TRU-016 in combination with 375 mg/m2 of rituximab and 90 mg/m2 of bendamustine, versus bendamustine and rituximab. The primary efficacy endpoint for the Phase 2 portion of the study is complete response (CR) rate as determined by using the Revised Response Criteria for Malignant Lymphoma. The pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study.
The total expected enrollment for both phases of this study is expected to be 88 patients, all of whom have a confirmed diagnosis of relapsed indolent B-cell lymphoma, and who have failed prior treatments. Study enrollment is expected to be completed by the end of 2012. Additional information about this Phase 1b/2 clinical study can be found at www.clinicaltrials.gov (protocol 16011).
About non-Hodgkin’s Lymphoma (NHL)
According to the National Cancer Institute, there are approximately 65,980 cases of NHL diagnosed each year, with close to 30% of these cases resulting in death. NHL is a broad range of malignant lymphoid disorders that are categorized on the basis of aggressiveness and cell of origin. Indolent or slow-growing NHL causes few symptoms, particularly early in the natural history of the disease, making early detection difficult. The majority of patients with indolent NHL present with Stage III or IV disease. Most patients with NHL requiring treatment receive rituximab in combination with chemotherapy as initial treatment; however, many patients become refractory to both chemotherapy and rituximab.
TRU-016 is a CD37-directed protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott. TRU-016 uses a different mechanism of action than currently marketed CD20-directed therapies. As a result, TRU-016 may provide patients with improved therapeutic options and enhance efficacy when used alone or in combination with chemotherapy and/or other immunotherapeutics. TRU-016 is currently in Phase 1b/2 development for chronic lymphocytic leukemia and non-Hodgkin’s lymphoma.
About Emergent BioSolutions Inc.
Emergent BioSolutions, led by Chairman and CEO, Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.
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, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, our expected revenue growth and net earnings for 2011, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. 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 other product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
SOURCE: Emergent BioSolutions Inc.
The Heifetz International Music Institute was established by Daniel Heifetz and is based in Ellicott City, Maryland. The institute also holds a six-week long summer festival program to train young musicians, held at Brewster Academy in New Hampshire.
The founder, violinist Daniel Heifetz, has played with many world-renowned orchestras and has taught master classes as well as university courses. As a young musician, Heifetz was mentored by legendary names such as Henryk Szyerng, Efrem Zimbalist, Jascha Brodsky, and Ivan Galamian.In 1996, Heifetz started the Heifetz Music Institute in an effort to draw in talented young musicians of violin, viola, and cello from all over the world.
The Institute is 501(c)(3) non-profit organization and can be supported through various giving opportunities. Its daily operations are led by Daniel Heifetz, but it is also guided by an advisory board whose members include local Maryland businessman Fuad el-Hibri.
Information can be found online about the institute, including reviews of past experiences. Violinist.com featured an article about the summer festival held by the Heifetz Institute from the perspective of a talented high school musician.More information about the institute can be found on its Facebook page.
Posted September 21, 2011on:
Emergent BioSolutions Inc. (NYSE: EBS) will be webcasting its presentation at the Jefferies 2011 Global Healthcare Conference in London on Tuesday, September 27, 2011 at 3:40 PM BST. During the presentation, a member of the company’s management team will provide a corporate overview, which may include a discussion of the company’s business activities and financial performance.
A webcast of this presentation will be available both live and by replay, accessible from the Emergent website www.emergentbiosolutions.com under “Investors.”
About Emergent BioSolutions Inc.
Emergent BioSolutions, led by Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent’s marketed and investigational products target infectious diseases, oncology and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.
Fuad El-Hibri was interviewed a few months ago by Ricardo Karam. This interview was aired in the 2011 season on the Ricardo Karam’sShow, which focuses on successful people from the Arab community. Ricardo Karam is a well known talk show host who has interviewed many high profile people, such as Celine Dion, Charles Aznavour, Paolo Coelho, Valentino, Kofi Annan, Andre Agassi and others.
Here is a summary of the televised interview: (Note that the interview begins in Arabic but switches to English within the first few minutes).
Born in Germany, Fuad El-Hibri came to America to be a self-proclaimed entrepreneur. With a strong ancestry from Europe and the Middle East, he believes that,“one identifies oneself by the way one is brought up.” “One never really loses one’s ancestry,” he says, as he describes his strong relationship with both a German and Middle Eastern Heritage. Being fluent in both English and Arabic, he describes language as a matter of practice and opportunity.
Born of a German mother and Lebanese father, he was brought up within multiple cultures. Having such a broad exposure to cultures, he was able to pick and choose aspects that fit his personality and life the best, creating a well-rounded lifestyle and culture that he looks fondly at.
He is a dedicated citizen to the U.S., being that the U.S. is where he lives and works. However, no matter how long he lives in the U.S. and adopts American culture, he will never forget his heritage and the cultures he originates from.
Ever since he was a young teen, El-Hibri had the goal of becoming an entrepreneur. He worked towards this goal while attending Stanford University. He views himself, “very lucky” to have all of the opportunities that were offered to him, like the ability to attend a prestigious college and obtain a good education. El-Hibri was then introduced by his father to a group of honest, hardworking businessmen that helped tojump-start his career.
His dream of becoming an entrepreneur always stemmed from wanting to do something meaningful; something that could help people’s lives, help with communication and help the environment. He did not want to create a company whose main goal was trade or simple moneymaking; profit was not his overall objective. Most importantly he wanted to build something that he and his family could be proud of.
Being very fortunate as a child and young adult, he was given the means and opportunities to make his dreams possible. Without his parents’ support, both emotionally and financially, he may never have accomplished everything he has toady. As the current CEO of Emergent BioSolutions, he was able to make his dreams come true.
Although he was given the support he needed to make his dreams become reality, none of it could have been possible without the hard work, effort and perseverance he put into his work. Becoming an entrepreneur didn’t come easily, and could never have been achieved without the determination El-Hibri has.
Looking fondly at his culture, family and life experiences, El Hibri has become the success he always wanted to be. Through hard work and perseverance, he can say that both he and his family are proud of everything he has accomplished.