NVENTA UNVEILS POSITIVE IMMUNOLOGICAL DATA FROM HSPE7 PHASE 1 TRIAL.Nventa Biopharmaceuticals Corporation (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :NVN NVN National Videotex Network NVN Never Winter Nights (game) ), San Diego. Calif., has announced interim immunological data from the first two cohorts of its ongoing Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. of its lead product candidate, HspE7, in patients with cervical intraepithelial neoplasia cervical in·tra·ep·i·the·li·al neoplasia n. Dysplastic changes beginning at the squamocolumnar junction in the uterine cervix that may be precursor to squamous cell carcinoma. , or CIN CIN cervical intraepithelial neoplasia. Cervical intraepithelial neoplasia (CIN) A term used to categorize degrees of dysplasia arising in the epithelium, or outer layer, of the cervix. , a precursor to cervical cancer. Preliminary evaluation of biological samples collected from the study's first and second cohorts indicates that administration of HspE7 results in an E7-specific T-cell immune response. Independent research findings recently published in the journal Gynecologic Oncology by Jeffrey Weber, M.D., Ph.D., associate director for clinical research at the University of Southern California's Norris Comprehensive Cancer Center, demonstrated that such an immune response may be associated with objectiveclinical responses in patients with CIN. Accordingly, Nventa believes that HspE7 may successfully treat CIN by activating and enhancing the body's natural immune system. As previously reported, doses administered in both study cohorts were found to be safe and well tolerated, with no serious adverse events being reported in either group. Cohort 1 was designed to establish a baseline for the study with patients in this group being administered 500 mcg of HspE7 and 50mcg of Poly-ICLC, a potent toll-like receptor 3 (TLR-3) adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. . Consistent with previous preclinical studies conducted by Nventa, this dose level demonstrated anti-HspE7 antibody responses but limited T-cell responses. In cohort 2, patients were administered 500 mcg of HspE7 and 500 mcg of Poly-ICLC. In this group, 3 out of 4 patients showed anti-HspE7 antibody responses and HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) 16 E7-specific T- cell responses. These findings verify the company's predicted mechanism- of-action of HspE7 as demonstrated by early preclinical models and support the compound's potential to treat HPV-16 induced CIN. HPV-16 is the most common sub-type of the HPV virus and is responsible for a significant percentage of cases of CIN. "We are very encouraged with the interim immunological results from our Phase 1 HspE7 trial as they demonstrate the anticipated immune response improvement from cohort 1 to cohort 2. We believe that these results may correlate to the activity of the drug in future clinical trials," said Gregory M. McKee, president and president executive officer at Nventa. "We look forward to reviewing the immunological data from the remaining two cohorts of this study to determine if yet higher doses of HspE7 will improve the drug's immunological activity. The company recently announced positive safety and tolerability findings from cohort 3 in this Phase 1 study, as well as the completion of enrollment and initiation of dosing for the study's fourth and final cohort. Safety and tolerability results from cohort 4 are expected soon. In addition to safety findings, immunological samples for the study's third and fourth cohorts are presently being collected and evaluated, and such findings will be released in the next several months. Nventa is currently working with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to finalize trial design for the company's Phase 2 clinical study for HspE7, and expects to initiate this trial in patients in CIN in mid-2008. In addition to CIN, Nventa is currently evaluating HspE7 as a potential treatment for a broad range of HPV-related pre-cancerous and cancerous diseases, and has a platform to generate other compounds that may treat a variety of other viral associated diseases. About Cervical Intraepithelial Neoplasia (CIN) CIN, also known as cervical dysplasia, is characterized by the presence in the cervix of abnormal cells that precede and can develop into cervical cancer. The primary cause of such abnormalities is infection with certain HPV types, of which HPV-16 is the most common. In the U.S., these infections are typically discovered through nearly 60 million Pap screens completed each year, at a cost of up to $6 billion. Each year in the U.S., an estimated 1.2 million women are diagnosed with low grade cervical dysplasia, (CIN 1), 300,000 with high grade dysplasia (CIN 2/3) and 2.4 million with atypical squamous cells of undetermined significance (ASCUS as·cus n. pl. as·ci A membranous, often club-shaped structure in which typically eight spores are formed through sexual reproduction of ascomycetes. ascus pl. asci; the spore case of Ascomycetes. ). No therapies other than surgery are currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of any type of CIN. About HspE7: The company's lead candidate, HspE7, is a novel therapeutic candidate intended for the treatment of precancerous precancerous /pre·can·cer·ous/ (-kan´ser-us) pertaining to a pathologic process that tends to become malignant. pre·can·cer·ous adj. and cancerous lesions caused by the human papillomavirus (HPV), one of the most common sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely in the world. HspE7 incorporates the proprietary adjuvant, Poly-ICLC, a toll-like receptor-3 (TLR TLR Trailer TLR Toll Like Receptor (immunological research) TLR Temple (University) Law Review TLR Twin Lens Reflex TLR Texas Law Review TLR The Last Resort (gaming clan) 3) agonist. An adjuvant is a substance added to vaccines to improve immune responses against target antigens. HspE7 is derived from Nventa's proprietary CoVal=99 fusion platform, which uses recombinant DNA technology recombinant DNA technology Recombining of DNA molecules from two different species that are inserted into a host organism to produce new genetic combinations that are of value to science, medicine, agriculture, or industry. to covalently fuse stress proteins to target antigens, thereby stimulating cellular immune system responses. Nventa is developing HspE7 for multiple indications. 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 company is publicly traded on the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. under the symbol NVN. For more information, visit http://www.nventacorp.com or call 415/675-7402. |
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