ASH News Daily - Sunday, December 11, 2011 - (Page B-21)

Sunday, December 11, 2011 ASH NewS DAily row transplantation program. While there, his mentoring skills contributed to the impressive professional growth of his laboratory trainees, many of whom presently occupy senior positions as department chairs. Dr. Brenner’s mentees recognize and appreciate his generosity of time and knowledge. During a job search, one mentee remarked that she chose the “collaborative, interactive environment that promotes good science” of Dr. Brenner’s laboratory over a higher salary. “He sets an extremely fine example of how one should conduct oneself in science. Not just ethically, but from a personal standpoint. He treats people with dignity and respect,” one mentee commented. The two individuals are chosen from the basic sciences and clinical investigation, respectively, and are awarded for the part they have played in the intellectual growth and career development of their mentees, in addition to their professional guidance and role modeling. He sets an example not only in the office but also as a family-oriented man. He prioritizes time with his family and is a devoted father who actively practices family values. His mentees have noted the partnership he shares with his wife Cleo, a virologist, highlighting their comple- Page B–21 ® Mentor Awards «« From Page B-4 and colleague said, “One of Malcolm’s major achievements in [the Center for Cell and Gene Therapy] was to establish an environment that encourages every member, from senior faculty to graduate student, to become a mentor to others.” Some of his former mentees send their trainees to be mentored by him, thus continuing the tradition of excellence of which they were a part. Prior to his time at Baylor, Dr. Brenner was Wellcome Trust Senior Lecturer at Royal Free Hospital where he led the stem cell transplantation research laboratory and worked on the bone mar- mentary research and co-publishing efforts. A well-rounded role model, Dr. Brenner currently has more than 200 people under his supervision and also works with other mentors on improving their own mentorship skills. With a certain British charm, he has influenced countless hematologists with his extensive knowledge of the field and sincere care for his mentees. Drs. Andrews and Brenner will be formally presented with their awards at the Announcement of Awards session today from 1:30 to 2:00 p.m. in Hall A/B. NMDP «« From Page B-1 7 DRUG INTERACTIONS No formal drug-drug interaction studies have been conducted with ARZERRA. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: There are no adequate or well-controlled studies of ofatumumab in pregnant women. A reproductive study in pregnant cynomolgus monkeys that received ofatumumab at doses up to 3.5 times the recommended human dose of ofatumumab did not demonstrate maternal toxicity or teratogenicity. Ofatumumab crossed the placental barrier, and fetuses exhibited depletion of peripheral B cells and decreased spleen and placental weights. ARZERRA should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. There are no human or animal data on the potential short- and long-term effects of perinatal B-cell depletion in offspring following in utero exposure to ofatumumab. Ofatumumab does not bind normal human tissues other than B lymphocytes. It is not known if binding occurs to unique embryonic or fetal tissue targets. In addition, the kinetics of B-lymphocyte recovery are unknown in offspring with B-cell depletion [see Nonclinical Toxicology (13.3)]. 8.3 Nursing Mothers It is not known whether ofatumumab is secreted in human milk; however, human IgG is secreted in human milk. Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation. Because the effects of local gastrointestinal and limited systemic exposure to ofatumumab are unknown, caution should be exercised when ARZERRA is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of ARZERRA have not been established in children. 8.5 Geriatric Use Clinical studies of ARZERRA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects [see Clinical Pharmacology (12.3) of full prescribing information]. 8.6 Renal Impairment No formal studies of ARZERRA in patients with renal impairment have been conducted [see Clinical Pharmacology (12.3) of full prescribing information]. 8.7 Hepatic Impairment No formal studies of ARZERRA in patients with hepatic impairment have been conducted. 10 OVERDOSAGE No data are available regarding overdosage with ARZERRA. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenicity studies of ofatumumab have been conducted. In a repeat-dose toxicity study, no tumorigenic or unexpected mitogenic responses were noted in cynomolgus monkeys treated for 7 months with up to 3.5 times the human dose of ofatumumab. Effects on male and female fertility have not been evaluated in animal studies. 13.3 Reproductive and Developmental Toxicology Pregnant cynomolgus monkeys dosed with 0.7 or 3.5 times the human dose of ofatumumab weekly during the period of organogenesis (gestation days 20 to 50) had no maternal toxicity or teratogenicity. Both dose levels of ofatumumab depleted circulating B cells in the dams, with signs of initial B cell recovery 50 days after the final dose. Following Caesarean section at gestational day 100, fetuses from ofatumumab-treated dams exhibited decreases in mean peripheral B-cell counts (decreased to approximately 10% of control values), splenic B-cell counts (decreased to approximately 15 to 20% of control values), and spleen weights (decreased by 15% for the low-dose and by 30% for the high-dose group, compared to control values). Fetuses from treated dams exhibiting anti-ofatumumab antibody responses had higher B cell counts and higher spleen weights compared to the fetuses from other treated dams, indicating partial recovery in those animals developing anti-ofatumumab antibodies. When compared to control animals, fetuses from treated dams in both dose groups had a 10% decrease in mean placental weights. A 15% decrease in mean thymus weight compared to the controls was also observed in fetuses from dams treated with 3.5 times the human dose of ofatumumab. The biological significance of decreased placental and thymic weights is unknown. The kinetics of B-lymphocyte recovery and the potential long-term effects of perinatal B-cell depletion in offspring from ofatumumab-treated dams have not been studied in animals. 17 PATIENT COUNSELING INFORMATION Advise patients to contact a healthcare professional for any of the following: • igns and symptoms of infusion reactions including fever, chills, rash, S or breathing problems within 24 hours of infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] • leeding, easy bruising, petechiae, pallor, worsening weakness, or fatigue B [see Warnings and Precautions (5.2)] • igns of infections including fever and cough [see Warnings and S Precautions (5.2) and Adverse Reactions (6.1)] • ew neurological symptoms such as confusion, dizziness or loss of N balance, difficulty talking or walking, or vision problems [see Warnings and Precautions (5.3)] • ymptoms of hepatitis including worsening fatigue or yellow discoloration S of skin or eyes [see Warnings and Precautions (5.4)] • ew or worsening abdominal pain or nausea [see Warnings and N Precautions (5.5)] • regnancy or nursing [see Use in Specific Populations (8.1, 8.3)] P Advise patients of the need for: • eriodic monitoring for blood counts [see Warnings and Precautions (5.2)] P • voiding vaccination with live viral vaccines [see Warnings and A Precautions (5.6)] Manufactured by: GLAXO GROUP LIMITED Greenford, Middlesex, UB6 0NN, United Kingdom U.S. Lic. 1809 Distributed by: life-saving efforts through hematopoietic cell transplantation. “NMDP is proud to be a part of this rigorous scientific field, whether through research, finding the right adult donor or cord blood unit, or providing education to physicians and their patients,” Dr. Dennis Confer, chief medical officer, NMDP, said. “Along with ASH, we once again congratulate the winners of these awards, and thank the researchers for their outstanding contributions.” Facts About Unrelated Hematopoietic Cell Transplants • NMDP has facilitated nearly 50,000 transplants, half of which have been in the last five years. • The NMDP’s Be The Match Registry® provides patients with access to more than 16.5 million potential donors and 550,000 umbilical cord blood units worldwide. Today, more than 50 percent of all transplants facilitated by NMDP involve either an international donor or recipient. • The likelihood that a patient will find a suitable adult donor on the Be The Match Registry ranges from 66 percent to 93 percent, depending on race or ethnicity. Cord blood and collaboration with worldwide registries increases this percentage. • In 2010 alone, NMDP and CIBMTR published 86 peer-reviewed articles and presented 95 abstracts at professional conferences to share key findings and best practices. B:15.125” T:14” S:12” GlaxoSmithKline Research Triangle Park, NC 27709 ©2011, GlaxoSmithKline. All rights reserved. September 2011 ARZ:6BRS ©2011 The GlaxoSmithKline Group of Companies All rights reserved. Printed in USA. AZA295R0 September 2011 

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ASH News Daily - Sunday, December 11, 2011

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