Tag Archives: CLL

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The Wild Story Behind A Promising Experimental Cancer Drug

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By David Shaywitz, Contributor Today, Pharmacyclics is a $5.3B company, a value attributable largely to its promising lead compound, ibrutinib, currently in late clinical development for chronic lymphocytic leukemia (CLL) and mantle cell lymphoma, and under investigation for a range of other B-cell malignancies.  A joint development and marketing deal with J&J was announced in late 2011, valued at nearly $1B, including $150M upfront plus significant milestone payments.  Analysts are already pegging future sales in the billions. …read more

Source: FULL ARTICLE at Forbes Latest

Business, Finance, Occupation & Industry

Emergent BioSolutions to Expand Front Line CLL Clinical Trial of TRU-016 and Rituximab Based on Stro

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By Business Wirevia The Motley Fool

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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 …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Canon U.S.A. Announces the 2013 Lineup of the Canon Live Learning Educational Events for Imaging Pro

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By Business Wirevia The Motley Fool

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Canon U.S.A. Announces the 2013 Lineup of the Canon Live Learning Educational Events for Imaging Professionals and Enthusiasts

MELVILLE, N.Y.–(BUSINESS WIRE)– Canon U.S.A., Inc., a leader in digital imaging solutions, today announced the 2013 Canon Live Learning (CLL) workshops and programs schedule. The on-site education program, now in its fourth year, is aimed at helping both advanced imaging enthusiasts and professionals elevate their knowledge of photography, filmmaking, and the technologies within Canon’s professional imaging and printing devices. CLL programs feature the EOS Immersion Seminars, EOS Destination Workshops, and Canon Professional Development Seminars and Workshops. Each of the programs offer an educational experience that will provide informative classes and hands-on instruction by a number of imaging professionals including Canon’s Explorers of Light (EOL).

“The Canon Live Learning program is an example of the emphasis Canon puts not only on the quality of its products, but also on the importance of educating customers so they maximize their imaging experience,” stated Yuichi Ishizuka, executive vice president and general manager, Imaging Technologies and Communications Group, Canon U.S.A. “The goal of these educational programs is to empower our customers to expand their creative visions.”

CLL programs are available throughout the United States and, as in previous years, the 2013 EOS Immersion series of seminars and workshops will be presented in a weekend format with the EOS Immersion Seminar on Saturday, followed by the choice of two EOS Immersion Workshops on the following Sunday. The EOS Immersion Workshop hosts participants in a studio setting where they will be taught photographic and HD Video techniques, and where they are encouraged to try Canon’s latest EOS equipment, and accessories in order to gain a greater knowledge of Canon’s imaging products.

Canon representatives will be on-hand to provide technical assistance at all CLL events to help ensure that any questions and concerns can be answered accurately and immediately. For more information on CLL, including the schedule of classes and pricing information, visit www.usa.canon.com/canonlivelearning.

In 2013, the first half of the Canon EOS Immersion series is currently set to be held in the following cities:

…read more
Source: FULL ARTICLE at DailyFinance
Business, Finance, Occupation & Industry

Enobosarm Phase 2 Trial for Muscle Wasting and Physical Function in Patients with Cancer Published i

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By Business Wirevia The Motley Fool

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Enobosarm Phase 2 Trial for Muscle Wasting and Physical Function in Patients with Cancer Published in The Lancet Oncology

Trial demonstrated significant increases in lean body mass (muscle) and physical function in cancer patients treated with enobosarm

MEMPHIS, Tenn.–(BUSINESS WIRE)– GTx, Inc. (NAS: GTXI) today announced that the journal, The Lancet Oncology, has published online ahead of its April print edition (www.thelancet.com/journals/lanonc/onlinefirst) the results from GTx’s randomized, double-blind, placebo-controlled Phase 2 clinical trial of enobosarm to assess its effects on muscle wasting and physical function in patients with cancer. Enobosarm (GTx-024) is a selective androgen receptor modulator (SARM), a new class of non-steroidal, tissue-specific anabolic agents that has the potential to increase muscle mass and improve physical function without the unwanted side effects on the prostate, skin or hair that are commonly associated with testosterone or non-selective, synthetic anabolic steroids. The lead author was Dr. Adrian S. Dobs, Professor of Medicine at the Division of Endocrinology and Metabolism, Johns Hopkins University School of Medicine in Baltimore, Maryland.

Cancer-induced muscle wasting begins early in the disease process, resulting in decreased physical function and other detrimental consequences, such as fatigue and weight loss, which can contribute to disability, reduced quality of life and shorter overall survival, compared with patients without muscle loss. There are no drugs approved for the prevention and treatment of muscle wasting in patients with cancer. The Phase 2 trial, which enrolled patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or breast cancer, demonstrated significant increases in lean body mass (primary endpoint) and physical function (one of the secondary endpoints) in patients treated with enobosarm 1 mg or 3 mg oral daily doses. Patients receiving placebo during the same period did not show significant increases in total lean body mass or in physical function.

The lead author, Dr. Adrian Dobs, an investigator in the Phase 2 trial, stated, “Muscle wasting is a common and devastating cancer-related symptom for which there are no effective therapies today. This is the first well controlled clinical trial to show that a selective anabolic agent, enobosarm, has the ability to not only increase muscle mass, but also improve physical function in a clinically relevant stair climb activity across a broad number of cancer types. After seeing the results of this Phase 2 clinical trial, I am looking forward to the results from the two Phase 3 clinical studies, POWER 1 and POWER 2, to confirm enobosarm’s ability to prevent and treat muscle wasting in patients with advanced non-small cell …read more
Source: FULL ARTICLE at DailyFinance