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NVENTA™ ANNOUNCES POSITIVE HSPE7 DATA FROM NCI-SPONSORED CLINICAL TRIAL IN HIV-POSITIVE PATIENTS
- First Clinical Evidence that HspE7 May Have Activity in Immunocompromised Patients -
FOR IMMEDIATE RELEASE June 15, 2006
San Diego, California USA - Nventa Biopharmaceuticals Corporation (TSX: NVN) today announced results, recently published in the journal AIDS, from a clinical trial to test HspE7, an investigational therapeutic vaccine for human papillomavirus (HPV)-related diseases, on patients with high-grade anal intraepithelial neoplasia (AIN), or dysplasia, in HIV-positive individuals. The trial was conducted by the AIDS Malignancy Consortium at the University of California in San Francisco and was sponsored by the U.S. National Cancer Institute
The Phase I/II trial tested HspE7 in three cohorts of five participants each assigned to receive variable doses of HspE7 through three injections at four-week intervals. Anal disease was assessed by pathology at 8, 12, 24 and 48 weeks, and 39 different types of HPV were measured, including types 16, 18 and 31. At 48 weeks, five of the fifteen participants in the trial (33 percent) responded to HspE7 and regressed to low-grade anal or no significant dysplasia. All participants had at least one oncogenic HPV type at baseline. Three of five (60 percent) of the participants who regressed to low-grade dysplasia or no significant dysplasia became HPV-negative, compared with none of the ten participants with no clinical response (p=0.02).
“HspE7 was well tolerated in this HIV-positive patient group,” said Joel M. Palefsky, M.D., Professor of Medicine and Associated Dean for Clinical and Translational Research at the University of California, San Francisco, a world-renowned expert in the field of anal dysplasia, and investigator in several Nventa trials with HspE7. “Despite the small patient population seen here, it was remarkable to observe that HPV was not detected at the end of the study in sixty percent (60 percent) of the participants who achieved disease regression.”
“These data suggest a potential for HspE7 in immunocompromised and HIV-positive patients, many of whom have high HPV infection rates and experience more rapid progression of HPV-related diseases,” said Gregory M. McKee, President and Chief Executive Officer at Nventa. “Nventa is positioned at the forefront of therapeutic vaccine development and may be one of the first companies to successfully bring a new therapeutic vaccine for HPV-related diseases to market.”
Nventa is now working on a more potent version of HspE7 than was used in this trial. Over the next year, Nventa intends to focus its resources on the following goals:
- Completion of acute safety, toxicology and pharmacodynamic studies of the reformulated drug candidate, seeking presentation and/or publication of these data.
- Completion of preclinical and clinical regulatory packages and submission to the U.S. Food and Drug Administration (FDA) for review prior to initiation of clinical trials.
- Initiation of a 400+ patient, three-arm, Phase I/II study in patients with genital warts that will include placebo, adjuvant and HspE7.
- Evaluation and design of a Phase II study in patients with high-grade cervical dysplasia.
- Evaluation and design of a Phase II//III study in patients with Recurrent Respiratory Papillomatosis (RRP), a trial that could potentially be used as a single registration trial, given the orphan indication and high unmet medical need.
About Nventa Corporation:
Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by the human papillomavirus (HPV). The corporation is publicly traded on the Toronto Stock Exchange under the symbol NVN. For more information about Nventa, please visit the website located at www.nventacorp.com.
About HspE7, Lead Product Candidate:
HspE7 is a novel CoVal™ fusion therapeutic vaccine for the treatment of diseases caused by the human papillomavirus (HPV), one of the most common 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 head and neck cancers.
This press release contains forward-looking statements that involve risk and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward looking statements, including, without limitation, statements regarding our corporate strategies, development plans and objectives relating to therapeutics for the treatment of viral infections, the completion of studies relating to our reformulated drug candidate, the completion of regulatory packages and their submission to the FDA, the initiation of a 400+ patient Phase I/II study and the evaluation and design of a Phase II/III study in patients with RRP that may potentially be used as single registration trial. You can identify many of these statements by looking for words such as “intends,” “believe,” “expects,” “will,” “projects,” “anticipates,” “estimates,” “continues” or similar words or the negative thereof. The predictions described in these statements may not materialize if management’s current expectations regarding our future performance or events prove incorrect. Actual results could be materially different from those predicted or implied by these forward-looking statements due to factors over which we have limited control, including but not limited to our need and ability to raise additional funds, our ability to continue as a going concern, complexities in designing a single registration trial, the outcomes from clinical trials and our ability to meet regulatory approval requirements. Please refer to our filings with Canadian securities regulators, as well as filings of GIVC Publications Ltd., our predecessor entity, for more information on these and other applicable risks. We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events. For the above-noted reasons, you should not place undue reliance on forward-looking statements.
Contact:
Donna Slade
Director, Investor Relations
6055 Lusk Boulevard
San Diego, CA USA 92121
Dir: 858/202-4945
Fax: 858/450-6849
dslade@nventacorp.com |
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