Two related items in todays qxhealth news.
Jason
qxhealth.net
StressGen to proceed to Phase III with HspE7
Based on positive clinical data reviewed at an interim analysis of the Phase II AIN trial and investigators meeting held June 22-23rd, StressGen Biotechnologies Corp. announces that it will proceed directly to a Phase III clinical trial for HspE7 in the treatment of anal dysplasia (AIN).
This trial will be designed to generate additional data on both safety and efficacy in a larger number of patients for which the therapeutic is intended. In addition, the company will be initiating a program for HspE7 in the treatment of genital warts.
"This is the first indication of HspE7 's effectiveness in the clinic - we are very excited," said Daniel Korpolinski StressGen's President and CEO, in a company statement. "The decision to move forward with our lead product HspE7 and expand its indications to include genital warts - one of the fastest growing sexually transmitted diseases affecting both men and women - reinforces the potential of our platform technology as a powerful immunotherapeutic approach."
Based on the positive clinical data and the recommendations of the data monitoring committee regarding the Phase II AIN trial, which were supported by the Phase I cervical dysplasia (CIN) draft study report, StressGen will stop the enrollment of new patients to the current Phase II AIN trial and complete the study with the patients currently enrolled. The company has submitted data available from the Phase II AIN for presentation at the International Human Papillomavirus Conference held in Barcelona, Spain the week of July 23rd-28th.
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qxhealth.net
Anal cancer increase linked to HPV infection
A new study conducted by GayHealth.com(TM) co-founder Dr Stephen E. Goldstone, presented at the annual meeting of the American Society of Colon and Rectal Surgeons, shows a startling increase in anal cancer in gay men. The increase is attributable to the human papillomavirus (HPV), a sexually transmitted virus that causes cervical cancer in women and which is found in nearly 100 percent of HIV-positive gay men and in approximately 65 percent of HIV-negative gay men.
"The alarming rise in anal cancer in gay men is a wake up call to the gay community and to healthcare providers worldwide," said Dr Goldstone, Medical Director of GayHealth.com, in a press release. "We cannot afford to ignore the signs of this impending epidemic nor can gay men or their physicians ignore even the slightest anal abnormality simply because they may be too embarrassed to discuss it."
Dr Goldstone studied more than 200 men referred to his New York City surgical practice for presumed benign anorectal diseases including anal warts, hemorrhoids, fissures, fistulas and anal itch. Patients received general physicals followed by thorough anorectal examinations, including the administering of anal Pap smears. Dr Goldstone found that 68 percent of HIV-positive men had high-grade dysplasia (abnormal and sometimes pre-cancerous growth of cells), as did 45 percent of HIV-negative men.
Overall, 60 percent of all patients referred for benign anorectal disease exhibited signs of high-grade dysplasia. Three percent of gay men examined had invasive anal cancer. For HIV-infected gay men, the likelihood of developing anal cancer increases 34-fold, according to data reported last month to the NIH.
Studies estimate that 35 HIV-negative gay men per 100,000 have anal cancer, which is four-times the current rate of cervical cancer in women. Widespread use of Pap smears brought about a dramatic decrease in rates of cervical cancer. HIV-infected gay men are estimated to have twice the rate of anal cancer as HIV-negative gay men.
With aggressive screening with cervical Pap smears for women, high-grade lesions may be discovered and removed before they have a chance to become cancer. Dr Goldstone applies the same principles to his treatment of anal HPV infections in men and urges other doctors to do the same.
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