Phase II Trial of HPV Therapeutic Vaccine Produces Promising Results
According to a press release from Transgene, an experimental human papillomavirus (HPV) therapeutic vaccine resulted in the disappearance of high-grade precancerous changes to the cervix in nine out of 18 vaccinated women.
Human papillomavirus (HPV) is a sexually transmitted infection that is the primary cause of cervical cancer. Different types of HPV are classified as “low-risk” or “high-risk” based on how likely they are to cause cervical cancer.
While several types of HPV have been linked with cervical cancer, HPV types 16 and 18 are thought to account for roughly 70% of all cervical cancer cases. High-risk types of HPV also contribute to the development of precancerous changes to the cervix known as cervical intraepithelial neoplasia (CIN). High-grade CIN (CIN2 and CIN3) can progress to cancer if not treated.
The link between HPV and cervical cancer opened important avenues of research. These included the development of tests to identify women infected with high-risk types of HPV, as well as work on HPV vaccines.
The HPV vaccines under development fall into two broad categories: preventive and therapeutic. Preventive vaccines are designed to prevent infection with the virus, whereas therapeutic vaccines would treat the infection, the precancerous changes, or the cancer in individuals who are already infected.
Prevention of infection is the ultimate goal, but treatment of existing infections and cervical abnormalities would benefit the many women who are infected currently.
Although the vaccines that are farthest along in development (Gardasil™ and Cervarix™) are both preventive vaccines, research into therapeutic vaccines continues. In order to assess the safety and effectiveness of an experimental HPV therapeutic vaccine, researchers in France conducted a phase II clinical trial among 21 women with HPV 16-related CIN2 or CIN3. The women ranged in age from 25 to 44. Rather than undergoing immediate surgery, the women were vaccinated with an experimental vaccine known as TG4001 and were observed by colposcopy (a magnified examination of the cervix) every two months.
At the end of six months of follow-up, information was available for 18 women:
Nine out of 18 women (50%) had no CIN2 or CIN3.
Nine out of 18 women (50%) had no evidence of the HPV proteins known as E6 and E7. These proteins are thought to play a role in HPV-related cancers.
There were no serious side effects of vaccination.
The researchers conclude that use of this experimental vaccine allowed 50% of women with HPV 16-related CIN2 or CIN3 to avoid surgery.
Reference: Transgene. Press Release. Transgene Announces Positive Phase II Results for its HPV Therapeutic Vaccine in Precancerous Cervical Lesions. April 25, 2006.
Human papillomavirus (HPV) is a sexually transmitted infection that is the primary cause of cervical cancer. Different types of HPV are classified as “low-risk” or “high-risk” based on how likely they are to cause cervical cancer.
While several types of HPV have been linked with cervical cancer, HPV types 16 and 18 are thought to account for roughly 70% of all cervical cancer cases. High-risk types of HPV also contribute to the development of precancerous changes to the cervix known as cervical intraepithelial neoplasia (CIN). High-grade CIN (CIN2 and CIN3) can progress to cancer if not treated.
The link between HPV and cervical cancer opened important avenues of research. These included the development of tests to identify women infected with high-risk types of HPV, as well as work on HPV vaccines.
The HPV vaccines under development fall into two broad categories: preventive and therapeutic. Preventive vaccines are designed to prevent infection with the virus, whereas therapeutic vaccines would treat the infection, the precancerous changes, or the cancer in individuals who are already infected.
Prevention of infection is the ultimate goal, but treatment of existing infections and cervical abnormalities would benefit the many women who are infected currently.
Although the vaccines that are farthest along in development (Gardasil™ and Cervarix™) are both preventive vaccines, research into therapeutic vaccines continues. In order to assess the safety and effectiveness of an experimental HPV therapeutic vaccine, researchers in France conducted a phase II clinical trial among 21 women with HPV 16-related CIN2 or CIN3. The women ranged in age from 25 to 44. Rather than undergoing immediate surgery, the women were vaccinated with an experimental vaccine known as TG4001 and were observed by colposcopy (a magnified examination of the cervix) every two months.
At the end of six months of follow-up, information was available for 18 women:
Nine out of 18 women (50%) had no CIN2 or CIN3.
Nine out of 18 women (50%) had no evidence of the HPV proteins known as E6 and E7. These proteins are thought to play a role in HPV-related cancers.
There were no serious side effects of vaccination.
The researchers conclude that use of this experimental vaccine allowed 50% of women with HPV 16-related CIN2 or CIN3 to avoid surgery.
Reference: Transgene. Press Release. Transgene Announces Positive Phase II Results for its HPV Therapeutic Vaccine in Precancerous Cervical Lesions. April 25, 2006.
posted by TM at 7:37 AM
0 Comments:
Post a Comment
<< Home