MIAMI BEACH, FL, March 21 /PRNewswire-FirstCall/ -- Stressgen Biotechnologies (TSX:SSB) announced today that data from a Phase II study in high grade cervical dysplasia using HspE7, the Company's lead drug product candidate for human papillomavirus (HPV)-related diseases, was presented by Mark Einstein, M.D., of Albert Einstein College of Medicine on behalf of the New York Phase II Consortium and under the sponsorship of the National Cancer Institute (NCI) at the Society of Gynecologic Oncologists Annual Meeting on Women's Cancer(TM). The Cancer Therapy Evaluation Program of the NCI and Stressgen Biotechnologies are collaborating on the development of HspE7 under a Clinical Trials Agreement.
"Among women with high grade cervical dysplasia (CIN III), HspE7 treatment resulted in a clinically significant pathologic response rate higher than the spontaneous regression rate anticipated in the protocol," said Dr. Mark Einstein, the principal investigator in the trial. "The fact that so many women with CIN III responded to HspE7 alone prior to surgery warrants further testing in women with CIN III and cervical cancer." Dr. Einstein is an Assistant Professor of the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology & Women's Health at the Montefiore Medical Center at Albert Einstein College of Medicine.
This NCI Phase II trial was designed to evaluate the efficacy and safety of HspE7 against CIN III. There were 31 women who completed the trial. Each patient received three subcutaneous injections with 500 mcg of HspE7 over a sixty-day period. Sixty days after the last injection, the women underwent a Loop Electrocautery Excision Procedure (LEEP) or Cone biopsy of the cervix, which are standard surgical procedures for patients with high grade dysplasia to remove the affected area. To evaluate the effect of HspE7, a complete pathologic response was defined as no evidence of high grade cervical dysplasia. A partial response was defined as colposcopic regression of the lesion by greater than 50 percent.
Of the 31 patients, 10/31 (32 percent) had a complete pathologic response; 12/31 (39 percent) had a partial response and 9/31 (29 percent) had stable disease. No patient had progressive disease. The overall response rate was 22/31 (71 percent). Further studies will need to be done to determine if women with complete responses may safely avoid the surgical procedures that are now standard treatments for high grade cervical dysplasia. The most common adverse events were injection site reactions; other adverse events were headache and flu-like symptoms. No patient had a serious drug-related adverse event during the observation period.
Nine women in this trial had a prior history of LEEP and subsequent recurrence. The response rate with HspE7 was 5/9 (56 percent) in these patients. This observation is important because it suggests that the patients who are difficult to treat because they have relapsed after LEEP may respond very well to HspE7.
"It is also possible that HspE7 may eliminate or prevent HPV infections," continued Dr. Einstein. "These women are still being observed in follow-up for evidence of HPV infection as well as recurrence of disease. Currently it is too early to determine if HspE7 could prevent HPV infection from recurring."
"We are seeing positive HspE7 results in high grade cervical dysplasia in two separate trials with a total of 52 patients," stated Dr. John Neefe, Senior Vice President of Clinical Research for Stressgen. These data from the NCI-sponsored trial, along with the data of Dr. Jeffrey Weber announced November 2004, will be used to guide our Phase III development plans for the indication of high grade dysplasia in women. Such trials will use our commercial-grade clinical trial supplies expected to be available mid-2005."
About Stressgen Biotechnologies Corporation:
Stressgen, a biopharmaceutical company, focuses on the discovery, development and commercialization of innovative therapeutic vaccines for the treatment of infectious diseases and cancer. The corporation is publicly traded on the Toronto Stock Exchange under the symbol SSB.
About HspE7, Lead Product Candidate:
HspE7 is a novel CoVal(TM) fusion therapeutic vaccine for the treatment of diseases caused by the human papillomavirus (HPV), one of the most common causes of sexually transmitted diseases in the world. An estimated 80 percent of sexually active men and women are infected by genital HPV at some point in their lives. Approximately 5.5 million new sexually transmitted HPV infections are reported in the U.S. each year. At least 20 million people in the U.S. are already infected. HPV infection can result in diseases including internal and external genital warts and precancerous conditions, such as cervical and anal dysplasia. Precancerous HPV-related conditions can progress into life-threatening diseases, including cervical, anal, and some head and neck cancers.
About Cervical Intraepithelial Neoplasia and Failures of LEEP:
CIN, also known as cervical dysplasia, is characterized by the presence in the cervix of abnormal cells that can precede and develop into cervical cancer. The primary cause of such abnormalities is infection with HPV types 16 and 18. Experts recommend screening all sexually active women for HPV. In the U.S. Pap screens, which are used to help detect HPV, are estimated to cost up to US$6 billion per year. An estimated 1.2 million women each year are diagnosed with low grade cervical dysplasia in the U.S. Another estimated 200,000 to 300,000 women are diagnosed with high grade cervical dysplasia in the U.S. each year. There are no FDA-approved drug therapies for CIN. Typically, high-grade CIN is treated with a type of surgery called LEEP, estimated to cost from US$400 to US$1,450 per treatment. The incidence of residual disease after LEEP varies from 20% to 30%. Potential complications include bleeding and the excessive removal of healthy tissue. LEEP is not recommended for lesions that are too deep to view with medical instruments. In those cases, widely used treatments include surgery, the cost of which varies depending upon the site of the lesion, or cold-knife cone biopsy, estimated to cost US$3,700 per treatment. None of the treatments are always effective in removing all abnormal cells. The recurrence rates of CIN have been estimated at 19% of patients treated with cryotherapy and 13% of patients treated with laser surgery or LEEP. In addition, the available treatments do not treat the underlying HPV infection.
About CoVal(TM) Fusion Proteins:
Stressgen capitalizes upon the immunostimulatory powers of heat shock proteins utilizing recombinant technology to fuse, or covalently link, a stress protein with a protein antigen to create a single hybrid protein designed to trigger the immune system to recognize that antigen. For more information about CoVal(TM) fusion technology, or Stressgen, please visit the website located at http://www.stressgen.com/.
This news release contains forward-looking statements that are subject to risks and uncertainties, including those about planned clinical trials, plans to develop HspE7 for cervical dysplasia and timelines for commercial-grade material. The actual results may differ materially from the expectations contained in our forward-looking statements due to factors including the possibility that future clinical results will not be consistent with early responses, the need for regulatory approval for HspE7, our dependence on collaborators and our need for additional capital. For more details regarding these and other risks, see our most recent annual report on Form 10-K, filed with the U.S. Securities and Exchange Commission and Canadian regulatory authorities.
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