Trubion Pharmaceuticals Inc.
(Nasdaq: TRBN) announced positive data from a Phase 1/2a study
demonstrating that repeat administration with TRU-015 continues to produce
persistent responses and significant improvements in rheumatoid arthritis
(RA) signs and symptoms based on American College of Rheumatology (ACR)
criteria. Trubion also announced positive results following preliminary
analyses from a Phase 2b study in which patients have received one course
of re-treatment with 800 mg of TRU-015. TRU-015 is being developed by Wyeth
Pharmaceuticals in collaboration with Trubion.
TRU-015 Phase 1/2a Re-treatment Data: Re-treatment Administered Every
24 Weeks for 2 Years Produces Well-Tolerated and Consistent Results
Re-treatment data from the Phase 1/2a study (15001) were presented on
Oct. 26, 2008, in a poster session at the ACR 2008 Annual Meeting in San
Francisco. Patients treated with a single course of TRU-015 at 5 mg/kg or
higher in a previously conducted Phase 1/2a study (15001) were eligible for
re-treatment. Patients given an initial dose of 5 mg/kg received a single
infusion of 5 mg/kg upon re-treatment and those given higher doses of
TRU-015 received a single infusion of 15 mg/kg upon re-treatment. Patients
were eligible for repeat therapy at 24-week intervals.
Thirty-eight patients entered the Phase 1/2a re-treatment study; some
patients have received as many as seven courses of TRU-015 at the time of
this assessment. At 24 weeks, ACR 20, 50 and 70 response rates for 18
patients that have received their third re-treatment with 5 mg/kg or 15
mg/kg TRU-015 were 50%, 17% and 11%, respectively. Ongoing patient
evaluations demonstrated maintenance of ACR responses following
administration of a single dose of TRU-015 at six-month intervals along
with B-cell depletion and recovery following re-treatment, comparable to
results seen after initial treatment.
Results from the Phase 1/2a re-treatment study also indicated total
serum IgG levels were relatively preserved. In addition, subjects treated
with three or more courses of therapy experienced persistent decreases in
rheumatoid factor and IgM levels. Re-treatment with TRU-015 did not result
in an increase in any adverse events compared with the initial infusion,
and the re-treatment infusions were well-tolerated. No neutralizing
antibodies to TRU-015 had been detected at the time of this assessment.
TRU-015 Phase 2b Re-treatment Data
A separate Phase 2b study (15002) is also ongoing. The initial
treatment results were presented last year. Re-treatment data from study
15002 were not available in time to present at ACR but will be submitted
for presentation in a future peer-reviewed forum. The objective of the two
ongoing re-treatment studies is to evaluate the safety; tolerability;
pharmacodynamics (PD), specifically, B-cell depletion over time;
pharmacokinetics; and immunogenicity of repeat doses of TRU-015 for RA
following initial administration.
Two hundred and forty patients entered the open-label re-treatment
portion of the Phase 2b study (15002) and received 800 mg of TRU-015. Data
was available for all 240 patients at the time of this evaluation, of which
204 patients were rheumatoid factor (RF) positive. Under the study
protocol, the efficacy endpoint was based on all randomized RF-positive
subjects who received any portion of study drug.
Based on the initial treatment results from studies 15001 and 15002,
the selected dose for re-treatment in 15002 and additional studies is 800
mg. Preliminary analyses demonstrate that at 24 weeks, ACR 20, 50 and 70
response rates for patients in the initial 800 mg dose group (n=43) who
were subsequently re-treated with 800 mg of TRU-015 were 70%, 40% and 23%,
respectively. Re-treatment with TRU-015 was generally well-tolerated. The
safety and PD effects after re-treatment were comparable to those seen
after initial therapy.
"We are very pleased with the results from the first course of
re-treatment under the Phase 2b study protocol," said Peter Thompson, M.D.,
FACP, president, CEO and chairman of Trubion. "These data demonstrate
improvement in RA signs and symptoms and, combined with data from more than
130 re-treatment courses administered over two years under the Phase 1/2a
study, continue to validate TRU-015 as a potential therapy for the
treatment of RA."
About Trubion
Trubion is a biopharmaceutical company that is creating a pipeline of
novel protein therapeutic product candidates to treat autoimmune and
inflammatory diseases and cancer. The company’s mission is to develop a
variety of first-in-class and best-in-class product candidates, customized
for optimal safety, efficacy and convenience that it believes may offer
improved patient experiences. Trubion’s current product candidates are
novel single-chain protein, or SMIP(TM), therapeutics, and are designed
using its custom drug assembly technology. Trubion’s product pipeline
includes CD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for
autoimmune and inflammatory diseases, developed under the company’s
collaboration with Wyeth Pharmaceuticals. Trubion’s product pipeline also
includes Trubion’s proprietary product candidate, TRU-016, a novel
CD37-targeted therapy for the treatment of B-cell malignancies that is
currently in Phase 1/2 clinical evaluation. In addition to Trubion’s
current clinical stage product pipeline, the company is also developing
additional product candidates that build on its product development
experience.
Forward Looking Statements
Certain statements in this release may constitute "forward-looking
statements" within the meaning of Section 21E of the Securities Exchange
Act of 1934 and Section 27A of the Securities Act of 1933. These statements
include, but are not limited to, those related to the company’s future
clinical development programs and the timing thereof, the company’s future
regulatory filings and the timing and outcome thereof and the company’s
expected financial and operating results. These statements are based on
current expectations and assumptions regarding future events and business
performance and involve certain risks and uncertainties that could cause
actual results to differ materially. These risks include, but are not
limited to, the risk that significant improvement in RA signs and symptoms
will not be observed after further re-treatment with TRU-015, risks
associated with the company’s Wyeth collaboration, including Wyeth’s
control over development timelines, the risks that the Company is unable to
advance its clinical development programs and regulatory applications and
action at the rate it expects, the risk that the Company does not achieve
the financial and operating results it expects, and such other risks as
identified in the company’s quarterly report on Form 10-Q for the period
ended June 30, 2008, and from time to time in other reports filed by
Trubion with the U.S. Generic levitra pills no prescription Securities and Exchange Commission. These reports are
available on the Investors page of the company’s corporate website at
Trubion undertakes no duty to update any
forward-looking statement to conform the statement to actual results or
changes in the company’s expectations.
Trubion Pharmaceuticals Inc.
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We are all familiar with the question - "Are you a man or a mouse?" What if the answer is "a little of both"? Because of the power of molecular genetics research in animals and the maturation of animal models, the path to identifying genes involved in particular types of behavior, such as fear, is much clearer in animals than in humans. There is new evidence that the genes implicated in these animal models may be directly applicable to humans.
A new genetic association study, appearing in the October 15th issue of Biological Psychiatry, evaluated genes that may be associated with the risk for human anxiety disorders. The scientists utilized a cross-species approach and tested 13 human homologs of genes that had previously shown to be differentially expressed in mouse strains that differed in their innate anxiety levels. The authors then studied groups of humans with anxiety disorders and found some evidence of association among six of these genes and particular anxiety disorders. Generic lasix pills no prescription The strongest associations were between variation in ALAD with risk for social phobia, DYNLL2 with risk for generalized anxiety disorder, and PSAP with risk for panic disorder.
John H. Krystal, M.D., Editor of Biological Psychiatry and affiliated with both Yale University School of Medicine and the VA Connecticut Healthcare System, comments, "This intriguing study by Donner and colleagues harnesses the power of the animal models to guide the search for genes that contribute to the risk for human anxiety disorders. This process led to a number of interesting candidates for future study."
Corresponding author Iiris Hovatta, Ph.D., further explains, "We found gene variants that seem to specifically predispose to certain anxiety disorder types, such as panic disorder, social phobia or generalized anxiety disorder. These findings give us an excellent starting point to investigate their molecular function in the brain and how the proteins coded by these genes regulate anxiety."
These findings still need to be replicated, and further research will be necessary to understand the extent that these specific genetic variants play in predisposing one to developing an anxiety disorder. However, as the authors conclude in their article, "Nevertheless, our results illustrate the potential utility of cross-species approaches in the identification of susceptibility genes for human psychiatric disorders."
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Michael Mullen, chair of the Joint Chiefs of Staff, recently proposed that all returning combat troops undergo screening for post-traumatic stress disorder with a mental health professional, according to USA Today. Troops currently fill out questionnaires after combat tours that aid in assessing their mental health and are examined by physicians for physical injuries, but they do not meet with a mental health professional. According to USA Today, a trained mental health professional can determine signs of PTSD within five minutes in an in-person meeting.
Mullen said troops often are reluctant to acknowledge psychological problems because they are hesitant to show weakness. According to Terri Tanielian, co-director of RAND’s Center for Military Health Policy Research, troops are concerned that seeking mental health treatment could negatively affect their military career. Mullen said the Pentagon has yet to address the negative connotation associated with mental health care. Mullen said, "I’m at a point where I believe we have to give a (mental health) screening to everybody to help remove the stigma of raising your hand."
There currently are no estimates regarding the potential cost of Mullen’s proposal or a start date. A shortage of available mental health professionals could hinder adoption of the proposal, although the military has increased signing and retention bonuses in recent years to address the issue. generic ultram online buy Another concern is that troops often know how to evade certain health questions to avoid treatment.
According to a RAND study, one in five combat veterans from Iraq and Afghanistan suffer from PTSD or depression. RAND estimates that 300,000 veterans have been affected and that it may cost more than $6.2 billion to treat them. The study also showed rates of PTSD and depression were highest among soldiers and Marines (Vanden Brook, USA Today, 10/13).
Reprinted with kind permission from You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation.? All rights reserved.
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The declining state of the Nation’s
economy is taking a physical and emotional toll on all people nationwide,
yet financial stress is impacting women and Hispanics in particular,
according to data from the American Psychological Association’s newly
released 2008 Stress in America survey.
When asked about the recent financial crisis, almost half of all adults
say that they are increasingly stressed about their ability to provide for
their family’s basic needs. At the same time, eight out of 10 adults said
that the economy is a significant cause of stress, up from 66 percent in
April(1). Compared to men, women are most likely to report unhealthy
behaviors to manage stress like eating poorly (56 versus 40 percent),
shopping (25 versus 11 percent), or napping (43 versus 32 percent) as well
as to report physical symptoms of stress like fatigue (57 percent compared
to 49 percent), irritability (65 percent compared to 55 percent), headaches
(56 percent compared to 36 percent) and feeling depressed or sad (56
percent compared to 39 percent).
Hispanics are more likely than Whites to say that the economy (70
percent Hispanics, 67 percent Whites), money (84 percent Hispanics, 68
percent Whites), housing costs (60 percent Hispanics, 41 percent Whites),
and job stability (55 percent Hispanic, 36 percent Whites) are significant
causes of stress.
Concern over the well-being of the family is taking a particular toll
on Hispanics. Overall, Hispanics are more likely to cite family
responsibilities (67 percent Hispanics vs. 56 percent Whites),
relationships (67 percent Hispanics vs. 58 percent Whites) and health
problems affecting their family (65 percent Hispanics vs. 54 percent
Whites) as significant sources of stress.
Financial Downturn Taking a Toll on Older Women, but All Are Affected
Women of the Boomer generation (aged 44 to 62) and Matures (aged 63+)
are most likely to report the economy as a significant stressor, while
women in general rank financial worries above personal health. Female
Boomers report increases in stress associated with their job stability and
health problems affecting their families. Mature women are reporting
dramatic increases in stress associated with health problems affecting
their families (up 17 points to 87 percent between April and September),
the economy (up 18 points to 92 percent) and money (up 15 points to 77
percent).
Generation Xers (ages 30 to 43) and Millennials (ages 18 to 29) are not
immune from financial worries. Generation Xers are the women most concerned
about money (89 percent report money as a source of stress) and Millennials
are most concerned about housing costs (75 percent report housing costs as
a source of stress).
Stress Affects Health and Coping Behaviors
In June 2008, more people reported physical and emotional symptoms due
to stress than they did in 2007, and nearly half (47 percent) of adults
reported that their stress has increased in the past year. More people
report fatigue (53 percent compared to 51 percent in 2007), feelings of
irritability or anger (60 percent compared to 50 percent in 2007) and lying
awake at night (52 percent compared to 48 percent in 2007) as a result of
stress, in addition to other symptoms including lack of interest or
motivation, feeling depressed or sad, headaches and muscular tension.
Almost half of respondents (48 percent) reported overeating or eating
unhealthy foods to manage stress, while one in four (39 percent) skipped a
meal in the last month because of stress. Almost one-fifth of persons
report drinking alcohol to manage their stress (18 percent), and 16 percent
report smoking.
"With the deteriorating economy dominating the headlines, it’s easy to
worry more about your finances than your health, but stress over money and
the economy is taking an emotional and physical toll on America," says
psychologist Katherine Nordal, PhD, APA’s executive director for
professional practice. "Many say they are handling their stress well. Yet,
people report more physical and emotional symptoms. If persons continue to
experience these high levels of stress for prolonged periods of time, they
are at risk for developing serious illnesses."
What Can People Do?
According to APA, the health consequences of extreme stress are most
severe when people ignore symptoms and fail to manage their stress well.
Buy generic diflucan Dr. Nordal advises people to be more mindful of their stress levels as well
as the emotional and physical symptoms of stress. Symptoms include
irritability, problems sleeping, changes in appetite, headaches, stomach
aches, intestinal problems, nervousness, excessive worry, and feeling sad
and depressed.
"People’s emotional and physical health is more vulnerable, given the
high levels of stress in our country right now," says Dr. Nordal. "Pay
attention to what’s happening around you, but refrain from getting caught
up in doom-and-gloom hype. Take stock of your particular situation and what
causes you stress. Reach out to family, friends and trusted advisors.
Research shows that receiving support from others is effective in managing
stress. If you continue to feel overwhelmed by stress, then consider
seeking professional help."
The Stress in America survey is part of APA’s Mind/Body Health public
education campaign. For information on the survey or managing stress, visit
Methodology
The 2008 Stress in America research was conducted online within the
United States by Harris Interactive on behalf of the American Psychological
Association between June 23, 2008 and August 13, 2008 among 1791 adults
aged 18+ who reside in the U.S.
The April data was collected online within the United States between
April 7 and April 15, 2008, among 2,529 U.S. residents aged 18 or older.
The September data was collected online within the United States between
September 19 and September 23, 2008, among 2,507 U.S. residents 18 or
older. Data for the April and September polls were collected using an
omnibus survey; the causes of stress question included a "not applicable"
response. Data presented here were calculated excluding those who responded
"not applicable."
No estimates of theoretical sampling error can be calculated; a full
methodology is available.
The American Psychological Association (APA), in Washington, DC, is the
largest scientific and professional organization representing psychology in
the United States and is the world’s largest association of psychologists.
APA’s membership includes more than 148,000 researchers, educators,
clinicians, consultants and students. Through its divisions in 54 subfields
of psychology and affiliations with 60 state, territorial and Canadian
provincial associations, APA works to advance psychology as a science, as a
profession and as a means of promoting human welfare.
(1) These statistics refer to data collected in September. All other
data referenced was collected June-August (see methodology).
American Psychological Association (APA)
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An estimated 35.1 million Americans live in "food insecure" households, meaning that at some time during the previous year they were unable to obtain or were uncertain of having enough food to fulfill their basic needs. Consequently, many of those people seek aid from federal sources including the Food Stamp Program. Now, a University of Missouri poverty expert has found that, depending on the food stamp benefit amount, the emotional distress associated with food insufficiency is higher among food stamp participants.
"Our hypothesis was that participation in the Food Stamp Program would have a positive impact on participants’ mental and emotional health, but the results were not what we expected," said Colleen Heflin, assistant professor with the MU Truman School of Public Affairs. "The results suggest the opposite - the negative mental health aspects of participating in the Food Stamp Program seem to outweigh the positive mental health aspects."
The negative mental health effects primarily occurred during participants’ application process and transition into the program. According to Heflin, the process can be time consuming and emotionally draining. Possible negative effects on emotional health include the stigma associated with food stamp participation, association with welfare culture and difficulty meeting eligibility requirements.
Previous research has been conducted on the health consequences associated with food insufficiency. Until now, researchers had not examined the impact of the Food Stamp Program on the relationship between food insufficiency and mental health.
"We found a dosage effect - such that food-insufficient individuals who received higher amounts of food stamp benefits suffered greater emotional distress than those who received lower amounts of food stamp benefits," Heflin said.
According to the study, further evaluation is necessary to find the direct cause for emotional distress in new food stamp participants. Heflin said that, based on the findings, modifications to the Food Stamp Program are needed to improve overall well-being among new participants. She suggests implementing a web-based application system, currently used in at least five states, that eliminates the face-to-face interview process and allows clients to choose the time and place they submit their applications. Heflin said future research will help determine the effectiveness of the web-based process.
—————————-
Article adapted by Medical News Today from original press release.
—————————-
The study, "Food Insufficiency, Food Stamp Participation and Mental Health" was published in the September issue of Social Science Quarterly. generic soma online buy It was co-authored by James P. Ziliak from the University of Kentucky.
Source: Emily Smith
University of Missouri-Columbia
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