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IDSA: Strep Vaccine Safe, Effective in Early Trial (CME/CE)
Posted by: admin in Pharmacy Drugs on November 06th, 2009
- Explain to interested patients that group B streptococcus is a major cause of sepsis and meningitis in newborns in the U.S.
- Note that this study details early steps toward a vaccine against the pathogen.
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.
PHILADELPHIA — An investigational vaccine against a strain of group B streptococcus that causes sepsis and meningitis in newborns was safe and modestly effective, a researcher said here.
In a Phase II, double-blind, randomized trial, the vaccine against serotype III of the bacteria did a better job of preventing colonization in women than placebo, according to Sharon Hillier, PhD, of the University of Pittsburgh.
The most common adverse events were injection site tenderness and pain, Hillier reported at the annual meeting of the Infectious Diseases Society of America.
Group B streptococcus, commonly found in the gut and genital tract, can cause disease in pregnant women, the elderly, and adults with some chronic conditions.
But the reason researchers are seeking a vaccine is that when it’s transmitted during delivery, group B streptococcus is also the most common cause of sepsis and meningitis in newborns in the U.S.
The test vaccine is a combination of the bacterial polysaccharide and tetanus toxoid and was compared with a licensed tetanus and diphtheria vaccine in 650 sexually active women, nonpregnant women who were not colonized with the bacteria at baseline, Hillier said.
The women were tested bimonthly after vaccination to see if they had been colonized or infected by Group B streptococcus, she said. The primary endpoint was time to acquisition of the bacteria.
The researchers found:
- For preventing vaginal acquisition of type III Group B streptococcus, the vaccine efficacy was 35%, which was significant at P=0.044.
- For rectal acquisition, efficacy was 43%, significant at P=0.015.
Women in the vaccine group also had a robust immune response to the bacteria.
The geometric mean concentration of serum IgG to the bacteria two months after vaccination was 12.6 micrograms per milliliter, compared with 0.30 in the control group, a difference that was significant at P<0.0001, Hillier reported.
As well, 95% of women in the vaccine group — but less than 1% of the controls — responded with at least a four-fold rise in serum IgG above prevaccination levels, she said.
Antibody production rather than prevention of colonization is a more common measure of vaccine efficacy although prevention of infection is the gold standard for efficacy.
Currently, physicians screen women for group B streptococcus before delivery, according to Neil Fishman, MD, of the University of Pennsylvania, an infectious diseases specialist who was not part of the study.
If the test is positive, antibiotics are used to clear the pathogen, he said, “but this isn’t perfect, as the bacteria can be resistant to the antibiotics.”
The study is preliminary but encouraging, said Larry Pickering, MD, of Emory University in Atlanta, who was not part of the study but who moderated the session at which the data were presented.
“It’s important, in that they showed it prevented colonization,” he said. “But there’s still a lot of work to do” to get broader and more powerful protection.
The study was supported by the NIH. Hillier reported financial links with Johnson & Johnson and Merck.
Primary source: Infectious Diseases Society of America
Source reference:
Hillier SL, et al “Women receiving group B streptococcus serotype III tetanus toxoid (GBS III-TT) vaccine have reduced vaginal and rectal acquisition of GBS type III” IDSA 2009; Abstract 186.
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New Tests For Identifying Potentially Deadly Adulterants In Pharmaceutical Ingredients
Posted by: admin in Pharmacy Drugs on November 06th, 2009
To further protect patients from adulterated medicines, the U.S. Pharmacopeial Convention (USP) has announced revised standards for four ingredients widely used in prescription and over-the-counter drugs. The standards, posted on the USP Web site, include new tests for identifying two harmful and potentially deadly contaminants in the four pharmaceutical excipients - inactive ingredients common in medicines for purposes including sweetening agents and solvents.
USP is a nonprofit, scientific organization that sets legally recognized standards designating the identity, quality, purity, strength and consistency of prescription and over-the-counter medications and their ingredients in the United States. These standards are enforced by the U.S. Food and Drug Administration (FDA). The revisions respond to a request from FDA to revise the USP Propylene Glycol and Sorbitol Solution standards to include limits for diethylene glycol (DEG) to help prevent future episodes of pharmaceutical adulterations with this poisonous chemical. DEG is commonly used in antifreeze and has no legitimate place in medicines. Adulterations of cough syrups and other products with DEG have occurred many times and in many countries, including a tragic episode between November 2008 and January 2009 in which 84 children in Nigeria died after ingesting teething syrup contaminated with DEG. A similar episode occurred in July 2009 in Bangladesh, killing at least 24 children.
The revisions come after USP recently updated its standard for Glycerin, another pharmaceutical excipient. Consistent with the Glycerin revision, the updated “high priority” standards for the pharmaceutical excipients will help ensure the absence of DEG and ethylene glycol (EG), another poisonous chemical, each at a level of not more than 0.10 percent. The standards will become official February 1, 2010, allowing for a 12-week implementation period. All manufacturers using these pharmaceutical excipients in their U.S.-marketed products will be required to comply with these new standards once official.
“The adulteration of drugs and their ingredients is a critical public health issue,” said Susan de Mars, USP chief documentary standards officer. “As recently as a few months ago, this was tragically illustrated in separate instances in Bangladesh and Nigeria. USP, in close collaboration with FDA, manufacturers, and other national and international parties, is addressing this by updating our standards for ‘at risk’ products. The unfortunate reality of economic incentives to counterfeit medicines makes this necessary.”
The revision effort additionally proposed new standards for USP Sorbitol Sorbitan Solution and Noncrystallizing Sorbitol Solution. The four revised monograph standards were originally posted on the USP Web site on July 1 to allow manufacturers, regulators and all other interested parties until August 14 to review the proposed changes - found in the “Identification” sections of the monographs - and provide informal comment on USP’s approach prior to its formal posting via USP’s Revision Bulletin process. USP also held three open Web meetings to communicate these proposed revisions to stakeholders.
In addition to the written standards, USP has developed physical reference materials for the pharmaceutical excipients as well as impurities reference materials for DEG and EG. These physical materials are used by manufacturers and regulators to ensure a substance meets the USP written standards.
For more information, visit http://www.usp.org/hottopics/propyleneGlycolSorbitolInformation.html
Source: Francine Pierson
US Pharmacopeia
Completion Of Phase I Clinical Trial Of Sancuso(R) In Japanese Volunteers
Posted by: admin in Pharmacy Drugs on November 06th, 2009
Solasia Pharma K.K., a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced the completion of a Phase I clinical trial for SP-01 (extended release transdermal granisetron patch; brand name: Sancuso®) in Japanese volunteers.
Sancuso is the first and only commercialized extended release granisetron transdermal product. Sancuso was approved for the prevention of chemotherapy-induced nausea and vomiting and launched in the U.S. in 2008. In Japan, granisetron injections and tablets have strong market acceptance with over 50% share of the anti-emetic market.
Solasia also announced a U.S. patent for Sancuso was granted on October 27, 2009 to ProStrakan Group plc who developed and own the worldwide rights to Sancuso. The patent relates to a transdermal patch containing granisetron. “We are very pleased that Prostrakan has obtained the grant of the U.S. patent for Sancuso. This follows patent grants in the EU in 2007 and Japan in 2008, and reaffirms our confidence in the strength of the IP relative to other transdermal granisetron formulations including all such products currently in clinical development in Japan,” stated Solasia president Steve Engen.
About Sancuso
Sancuso is an extended release transdermal system, delivering the anti-emetic, granisetron, steadily into the patient’s bloodstream over seven days without the need for injections or swallowing pills. Granisetron is a 5-HT3 receptor antagonist with well-established efficacy against chemotherapy-induced nausea and vomiting (CINV). Sancuso was approved by the U.S. Food & Drug Administration (FDA) on September 12, 2008 for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. Prostrakan launched Sancuso in the U.S. in the fourth quarter of 2008. Patents protecting Sancuso have been granted in the EU (2007) and Japan (2008).
Source
Solasia Pharma K.K.
View drug information on Sancuso.
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