Immune Response Modifier Demonstrates Nearly 80% Success Rate in Adolescent Females with Genital Warts

New Study May Impact Future Treatment of Adolescent Girls

With External Genital Warts Caused by Human Papillomavirus (HPV)



Apr 30, 2001, 01:00 ET from 3M Pharmaceuticals

    CHICAGO, April 30 /PRNewswire/ -- Results of a new study showed that
 Aldara(TM) (imiquimod) cream 5% is a highly effective treatment for adolescent
 girls with the sexually transmitted disease genital warts.  Nearly 80% of the
 patients studied had complete clearance of their warts, and 95% had greater
 than 50% reduction in the size of their lesions.  Aldara(TM) is the first in a
 new class of drugs called immune response modifiers (IRMs) that demonstrate
 both antiviral and antitumor activity.  IRMs act by stimulating the patient's
 own immune system to fight the virus and therefore resolve the warts.  Aldara
 was approved by the U.S. Food and Drug Administration (FDA) in June 1997 for
 use in patients 18 and older with external anogenital warts.
     "This study is significant because it is among the first to demonstrate
 that treatment with an immune response modifier is beneficial in this
 important patient population," said Ricardo Estape, M.D., Associate Professor
 of Gynecologic Oncology at the University of Miami Sylvester Comprehensive
 Cancer Center, who is the lead investigator of the study.  "Adolescents with
 sexually transmitted diseases such as genital warts typically have very poor
 compliance rates with office-based treatments, so a therapy like Aldara, which
 patients can use in the privacy of their home, can potentially have an
 enormous impact."
     Approximately four million Americans suffer from genital warts, caused by
 the human papillomavirus (HPV).  As many as 24 million Americans have been
 exposed to HPV, making it the fastest spreading sexually transmitted viral
 disease.  HPV is associated with cervical cancer in women.  Young people are
 particularly vulnerable to STDs; in fact, three million teenagers are infected
 with a sexually transmitted disease each year.
     HPV is spread through skin-to-skin contact, so even condoms may not
 provide adequate protection against the virus.  Many people with HPV will not
 have any outward symptoms and they can harbor the virus for years, unknowingly
 infecting other sexual partners.
     Prior to the availability of the immune response modifier Aldara,
 traditional treatments for genital warts were typically performed in the
 physician's office and involved surgical, laser or chemical removal that is
 often associated with pain, tissue destruction and scarring.  Aldara is a
 patient-applied therapy, and is unique because it stimulates the body's own
 immune system to fight the virus.
     "HPV or genital warts can be extremely embarrassing for a young person,
 and adolescents often fail to complete treatment regimens or seek treatment at
 all.  This study shows great promise for the treatment of this disturbing
 sexually transmitted disease that has quickly become an epidemic among young
 people," said Dr. Estape.
 
     Trial Results
     The open-label, 2-year trial enrolled 51 female patients between the ages
 of 12 and 18 diagnosed with external genital warts; however, nine patients
 were deemed ineligible due to missed appointments.  Patients applied Aldara
 every three days with intervals increasing to five to six days based on
 symptoms, and were monitored at 4-week intervals.  Side effects were monitored
 monthly.  Only a small number of patients (33%), kept all of their
 appointments; the majority were followed up by telephone.
     Of the 42 patients who completed the study, 78.6% had complete clearance
 of their lesions within the 16-week period.  The vast majority, 95%, had at
 least a 50% reduction in volume of their lesions.  Time to clearance ranged
 from three to 12 weeks.  Median time to clearance was 6.5 weeks.  Clearance
 rates were similar to studies of Aldara in female adults, and time to
 clearance was faster than in previous studies of adults.
     Side effects included mild erythema (74%) and moderate irritation (14%).
 None of the adolescents studied discontinued treatment due to side effects.
     In clinical trials with Aldara, most local skin reactions were mild to
 moderate and included erythema, erosion, flaking, edema, scabbing and
 induration at the wart site.  Most common application-site reactions were
 itching (26%), burning (16%) and pain (4%) at the wart site.  Application-site
 pigmentation changes have also been reported.
     New warts may develop during treatment.  The effect of Aldara cream on the
 transmission of genital warts is unknown.  Aldara cream may weaken condoms and
 diaphragms.  Sexual contact should be avoided while the cream is on the skin.
     For more information about Aldara cream, genital warts or HPV, visit the
 3M Pharmaceuticals web site at http://www.3m.com/aldara.
 
     3M Pharmaceuticals, dedicated to advancing the health care treatment
 options available to both men and women globally, focuses on the research and
 development of innovative products that will be marketed as drug delivery
 systems or branded pharmaceuticals.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X80231723
 
 

SOURCE 3M Pharmaceuticals
    CHICAGO, April 30 /PRNewswire/ -- Results of a new study showed that
 Aldara(TM) (imiquimod) cream 5% is a highly effective treatment for adolescent
 girls with the sexually transmitted disease genital warts.  Nearly 80% of the
 patients studied had complete clearance of their warts, and 95% had greater
 than 50% reduction in the size of their lesions.  Aldara(TM) is the first in a
 new class of drugs called immune response modifiers (IRMs) that demonstrate
 both antiviral and antitumor activity.  IRMs act by stimulating the patient's
 own immune system to fight the virus and therefore resolve the warts.  Aldara
 was approved by the U.S. Food and Drug Administration (FDA) in June 1997 for
 use in patients 18 and older with external anogenital warts.
     "This study is significant because it is among the first to demonstrate
 that treatment with an immune response modifier is beneficial in this
 important patient population," said Ricardo Estape, M.D., Associate Professor
 of Gynecologic Oncology at the University of Miami Sylvester Comprehensive
 Cancer Center, who is the lead investigator of the study.  "Adolescents with
 sexually transmitted diseases such as genital warts typically have very poor
 compliance rates with office-based treatments, so a therapy like Aldara, which
 patients can use in the privacy of their home, can potentially have an
 enormous impact."
     Approximately four million Americans suffer from genital warts, caused by
 the human papillomavirus (HPV).  As many as 24 million Americans have been
 exposed to HPV, making it the fastest spreading sexually transmitted viral
 disease.  HPV is associated with cervical cancer in women.  Young people are
 particularly vulnerable to STDs; in fact, three million teenagers are infected
 with a sexually transmitted disease each year.
     HPV is spread through skin-to-skin contact, so even condoms may not
 provide adequate protection against the virus.  Many people with HPV will not
 have any outward symptoms and they can harbor the virus for years, unknowingly
 infecting other sexual partners.
     Prior to the availability of the immune response modifier Aldara,
 traditional treatments for genital warts were typically performed in the
 physician's office and involved surgical, laser or chemical removal that is
 often associated with pain, tissue destruction and scarring.  Aldara is a
 patient-applied therapy, and is unique because it stimulates the body's own
 immune system to fight the virus.
     "HPV or genital warts can be extremely embarrassing for a young person,
 and adolescents often fail to complete treatment regimens or seek treatment at
 all.  This study shows great promise for the treatment of this disturbing
 sexually transmitted disease that has quickly become an epidemic among young
 people," said Dr. Estape.
 
     Trial Results
     The open-label, 2-year trial enrolled 51 female patients between the ages
 of 12 and 18 diagnosed with external genital warts; however, nine patients
 were deemed ineligible due to missed appointments.  Patients applied Aldara
 every three days with intervals increasing to five to six days based on
 symptoms, and were monitored at 4-week intervals.  Side effects were monitored
 monthly.  Only a small number of patients (33%), kept all of their
 appointments; the majority were followed up by telephone.
     Of the 42 patients who completed the study, 78.6% had complete clearance
 of their lesions within the 16-week period.  The vast majority, 95%, had at
 least a 50% reduction in volume of their lesions.  Time to clearance ranged
 from three to 12 weeks.  Median time to clearance was 6.5 weeks.  Clearance
 rates were similar to studies of Aldara in female adults, and time to
 clearance was faster than in previous studies of adults.
     Side effects included mild erythema (74%) and moderate irritation (14%).
 None of the adolescents studied discontinued treatment due to side effects.
     In clinical trials with Aldara, most local skin reactions were mild to
 moderate and included erythema, erosion, flaking, edema, scabbing and
 induration at the wart site.  Most common application-site reactions were
 itching (26%), burning (16%) and pain (4%) at the wart site.  Application-site
 pigmentation changes have also been reported.
     New warts may develop during treatment.  The effect of Aldara cream on the
 transmission of genital warts is unknown.  Aldara cream may weaken condoms and
 diaphragms.  Sexual contact should be avoided while the cream is on the skin.
     For more information about Aldara cream, genital warts or HPV, visit the
 3M Pharmaceuticals web site at http://www.3m.com/aldara.
 
     3M Pharmaceuticals, dedicated to advancing the health care treatment
 options available to both men and women globally, focuses on the research and
 development of innovative products that will be marketed as drug delivery
 systems or branded pharmaceuticals.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X80231723
 
 SOURCE  3M Pharmaceuticals