Positive Results from Phase III Trial of Gamunex R in Patients
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February 7, 2008 9:10 AM EST
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--
In the largest trial ever reported in CIDP (chronic inflammatory demyelinating polyradiculoneuropathy), Gamunex(R) (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) was shown to reduce functional disability, while also demonstrating a prolonged time to relapse and a decreased probability of relapse longer-term (up to one year). The primary endpoint, response in functional disability, was observed in 54 percent of subjects treated with Gamunex (2g/kg loading dose, followed by 1g/kg maintenance dose every three weeks) compared to 21 percent on placebo when assessed up to six months in the first treatment period. Longer-term (up to one year), the probability of relapse was lower with Gamunex compared to placebo, 13 percent versus 45 percent, respectively. The use of Gamunex in the treatment of CIDP is investigational and has not been approved by the FDA.
The study, published last week in The Lancet Neurology entitled "Intravenous immune globulin (10 percent caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomized, placebo-controlled trial," was sponsored by Talecris Biotherapeutics, Inc.(http://www.talecris.com
Conducted as a multicenter, multinational clinical trial in centers in Europe, the Middle East, and North and South America, the trial randomized 117 subjects with CIDP.
CIDP is a progressive or relapsing disease affecting 2 to 7 individuals per 100,000 worldwide. Its course is variable. The most common symptom patients experience is progressive weakness in the arms and legs resulting in disability.
"The ICE study is important for two key reasons," said Peter Donofrio, M.D., study co-author and Professor of Medicine, Dept. of Neurology, Vanderbilt University, Nashville, Tenn. "First, it shows that Gamunex was superior to placebo in this study in reducing functional disability and improving grip strength in CIDP subjects. Second, Gamunex was shown to lengthen the time to relapse during the six month to one year period of the study."
Study Details and Results
Eligible CIDP trial subjects were randomized to treatment with Gamunex (2g/kg as loading dose followed by 1g/kg every three weeks) or placebo for up to 24 weeks. In the first period, subject response (primary endpoint) was assessed based on functional disability measured by Inflammatory Neuropathy Cause And Treatment (INCAT) score. First period non-responders, i.e., those trial subjects with a one point or greater deterioration, no improvement during the first six week treatment period, or initial improvement followed by deterioration, were rescued by crossing over to the alternate therapy for up to 24 weeks or until non-response to alternate therapy was observed. First period responders or rescue responders to either study drug who showed and maintained a one point or greater adjusted INCAT score improvement were randomly reassigned to Gamunex or placebo for an additional 24-week long-term extension phase.
During the first treatment period, the primary endpoint (percentage of responders) for subjects treated with Gamunex was found to be more than twice that of placebo: 54 percent versus 21 percent, respectively (p
During the 24-week extension phase, the sub-group of 57 trial subjects who responded to Gamunex during the first treatment or rescue (crossover) period (31 were randomly reassigned to Gamunex and 26 received placebo) were assessed to determine if treatment with Gamunex (up to one year) could maintain long-term benefit. Subjects who continued to receive Gamunex had a significantly longer time to relapse than did placebo trial subjects (p
CI 0.05-0.70).
The incidence of serious adverse events per infusion was low, 0.8 percent for Gamunex, and 0.19 percent for placebo. Adverse events resulting in study discontinuation totaled three trial subjects for Gamunex and two trial subjects for placebo. The most common events seen with Gamunex were headache, fever, and elevated blood pressure.
"Talecris is pleased with the results observed in the ICE study in CIDP," said Steve Petteway, Ph.D., Senior Vice President, Research and Development, Talecris Biotherapeutics. "Consistent with our past efforts, it remains our goal to advance knowledge and improve care for patients with rare and difficult to treat conditions. Results from clinical trials with Gamunex have provided significant scientific contributions. Ultimately, we intend to develop and execute clinical trials that will lead to improved patient care."
About CIDP
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a neurological disorder often characterized by progressive weakness and impaired sensory function in the legs and arms. This disorder is caused by damage to the myelin sheath (the fatty covering that wraps around and protects nerve fibers) of the peripheral nerves. Signs and symptoms -- which usually develop slowly over weeks and progress over several months -- may include weakness of the arms, legs and face; tingling and numbness in the arms and legs (often beginning in the fingers and toes); as well as muscle aches and fatigue.
CIDP, affecting 2 to 7 individuals per 100,000 worldwide, can occur at any age and in both genders, although it is more common in young adults and in men.
About Gamunex
Gamunex is an IGIV therapy that contains antibodies purified from the donated blood plasma of thousands of people. Gamunex is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for idiopathic thrombocytopenic purpura (ITP).
Important Safety Information
Gamunex is contraindicated in individuals with known anaphylactic or severe systemic response to Immune Globulin (Human). Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physicians. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Gamunex does not contain sucrose. Glycine, a natural amino acid, is used as a stabilizer.
There have been reports of noncardiogenic pulmonary edema, rare reports of hemolytic anemia, and very rare reports of aseptic meningitis in patients administered with IGIV. Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. The most common side effects noted during clinical trials included headache, vomiting, fever, nausea, rash, and back pain.
As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. For additional information about Gamunex, please see www.gamunex.com
Full Prescribing Information.
Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, with revenues of approximately $1.2 billion in 2007, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 4,000 talented people worldwide.
To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com
Changde City National Physique monitoring the outcome of the research and analysis
Bin Ding had Jihong Huangjiang DENG Yue-SHENG Wen
1, the preamble of the National Physique monitoring is a basic sports system is the implementation of the National Fitness Program, the important supporting measures. 2000 in Hunan Province Sports Bureau leadership and organization, the National Physique, Changde City, a full investigation was conducted. Monitoring through sampling, on the one hand, Changde City have obtained first-hand the people s physique indicators data; On the other hand, a study destination, Changde City, the National Physical changes and scientific guidance to the masses fitness, training, and promoting economic and social development to provide a scientific basis. Carry out monitoring of the national constitution, the party and the aim of serving the Government to raise the quality of the people, relations in the 21st century China s socialist modernization as a whole.
Second, the organization and methods of crowd
Category 1672, the adult B 1666, a total of 4954 people for the effective sample size.
Third, results and analysis of (a) child, Changde City Group is the average height of men and 92.1 cm, 94.8 cm female, adult man 169.7 cm and 158.6 cm women, the elderly man was 167.1 cm and 156.9 cm woman. Adult height increased with age and growth, and achieve the highest value after a stable, and the late age increases.
(B) The weight weight is a reflection of human bone marrow, muscle, fat, and so the weight of an important indicator, under normal circumstances, the increase in body weight that muscles, muscle growth and the improvement of nutritional status.
Changde City, the average weight of 17.2 kg children, adults, men average 69.2 kg, 58.2 kg for women. The results showed that, Changde City adults, the elderly meet the standard weight of 67.4%, in line with the basic (including light weight slightly, slightly weight) of the standard weight of 93.1%, the percentage of overweight rate of 5.4 percent, at the middle level of the province.
Quetelet index from the comprehensive data we can see that the maximum age for men and women are enriched in the 55-year-old, male adequacy of the minimum age of 21 years old, the 23-year-old female, table 3-2-1.
Table changes in the scope of 3-2-1 Quetelet Index
C) Human skin fold thickness human skin fold thickness reflects the extent of human nutrition, muscle condition. Changde City of adults sebum average arm skinfold thickness of 13.7 cm thick, and skinfold thickness of the scapula 13.1 cm, abdominal skinfold thickness 17.8 cm, the average child care group suffered lacerations on the skinfold thickness of 5.1 cm, scapular of the skinfold thickness of 4.6 cm, abdominal skinfold thickness of 5.6 cm. These data indicate that Changde City nutritional status of the National Physical medium.
(4) Determination of FVC FVC, can reflect the thoracic development and respiratory capacity.
Changde City, the average adult male FVC 3140 ml, 2201 ml for women, the elderly man was 3012 ml, 1896 ml for women, the data lower than the province s average level.
Changde City adults FVC maximum peak age in the 24-year-old male, 27-year-old women, the biggest average were 3570 ml and 2546 ml, the peak age of the elderly group is the largest 63-year-old male, 57-year-old woman. From the age of FVC to observe the changes in male and female FVC were 26-30 years of age when the maximum. The results of the FVC change of the men and women in the 23 to 27-year-old, FVC growing, to achieve maximum at the age of 23-27, and 30-year-old former are maintained at a high level. After the 30-year-old with age, FVC a declining trend, to 55-year-old, man FVC decreased by 11.6 percent, a decrease of 9.3% in women, men and the rate of decline rate was significantly higher than that woman, as a physical function decline significantly beginning of the age, its causes yet to be further explored.
(5) Step index is a measurement of step test cardiovascular function, which uses a certain altitude level from top to bottom by a sustained campaign time, heart rate after exercise and the speed of recovery in terms of the ratio of index to evaluate the cardiovascular system of the exercise load reaction. Index greater that the cardiovascular function better.
Adults, Changde City, the average height for men was 56.3 and 56.9 for the average woman. Different groups of people, men and women farmers index for the highest level, 57.6 and 57.98, respectively, adult male population is the lowest index level management staff, adult female population is the lowest government agency personnel. Syria before the information also shows that the man FVC farmers in the various population is the highest it that the peasants Changde adult men in the various levels of cardiorespiratory function for the best crowd, which is due to farmers the result of years of physical activity.
(6) grip grip strength in Changde City adult men averaged 453 N, N 307 for women. From the age of grip strength to see the changes in both men and women in the 31-35 age reached the maximum grip strength, and remained relatively stable after the male 46 to 50 years old, 41 to 45-year-old woman, grip strength evident decline.
(7) Sit and Reach Sit and Reach Flexibility is a reflection of the human body, with the people s daily life and many sports are closely linked to the quality indicators.
Changde City child care group, the Sit and Reach adult average of 9.3 cm for child care, adult men was 5.2 cm and 7.2 cm for women. Different groups of people in the Sit and Reach of the top men and women are workers and peasants.
(8) standing vertical jump and child care jumped vertical jump, standing long jump reflects the strength of the human body and leg power, vertical jump, Changde City, the average adult height for men 41.2 cm, 28.5 cm women, men and children standing jump 52 cm, F 43cm.
Highest vertical jump men and women age 20 to 25 years of age are shown in table 3-8-1, vertical jump peak age of the table in this age range 3-2-1 Quetelet index of the 22-year-old male for the 45.8cm, and 30.6 cm for women. Both men and women vertical jump with age and the growth of a downward trend. At the minimum age of 40 (36.2 cm male, female 26.3 cm).
Table 3-8-1 vertical jump mean age of TAB
Changde City adults s average of 12.7, 14.9 s for women.
(10) push-ups (men)
Push-ups reflect man arm muscle strength. Changde City average for the 15 men, men push-ups in the value of the highest in the 26-30 years age group (see table 3-10-1), of which 20 to 29-year-old. Push-ups after the results with age, and showed a downward trend, at the minimum age of 40 for 14. Of all ages dropped by 15.4 percent.
Different groups of people, the highest number of push-ups for the office personnel (24), a minimum of farmers (21).
Table 3-10-1 man push-ups mean TAB ()
Lumbo-abdominal muscle strength. Changde City average of 18 times. In different groups of people, one minute sit-up for the highest number of government agencies, the lowest for farmers.
(12) eyes closed, one leg standing eyes closed, one leg standing reflects the body s ability to balance, the greater the age, as the body of the central nervous system to regulate balance, and coordination capacity will be lower balance will shorten the time. Changde City for the average adult male 22 s, 17 s for women, elderly men and 16 s, 13 s women.
(13) Integrated reaction time (41 years old and above indicators)
Reaction is a reflection of human nervous system reaction speed indicators, adults, Changde City, the average response time for men and 0.20 s and 0.21 s for women.
4, the conclusion (a) of the Constitution adults
The results show that 74.42 percent of the Changde City adult cardiovascular function, 64.74 percent of lung function at the lower levels, especially cardiovascular function is only 1 / 4 of adults achieve a good level, the 40-year-old age bracket, cardiac function, as 40-year-old over the age of the level of male than female, table 4-1-1.
Changde City have emerged weight adults overweight trend, on the other hand, but there are more than 1 / 4 of adults too light weight. Organs (especially male) than the more science and technology personnel overweight 4.4 percent, while science and technology personnel too light organs to make more than 6.2 percentage points. Middle-aged obesity, 36 to 40 age group the proportion of overweight and 14.1 percent, higher female, 15.2%.
Table 4-1-1 Changde City adults FVC test Statistics (%)
Changde City adults, the elderly participation in physical exercise Although the number amounted to more than 60 percent, but did not meet three times per week, thus, enhance the effectiveness of health is not satisfactory, in the promotion of heart, lung function will not effect significant.
(2) Countermeasures
Related: Positive Results from Phase III Trial of Gamunex R in Patients
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