ALACHUA, Fla.--(BUSINESS WIRE)--Nanotherapeutics, Inc. announced today enrollment of the first patient into a Phase II cervical cancer trial for Triapine®, sponsored by the Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI). Triapine® is a ribonucleotidereductase inhibitor (RNRi) that is under evaluation in combination with cisplatin and radiation as a radiosensitizing chemotherapeutic agent for women with advanced stage cervical and vaginal cancers. NCI and Nanotherapeutics are collaborating on the development of Triapine® under a Clinical Trials Agreement.
The trial is a double-blinded, randomized, multi-center study with a targeted enrollment of 73 women with advanced stage cervical/vaginal cancer and will investigate cisplatin and radiation therapy, with or without Triapine®. Subjects in the trial will have previously untreated stage IB-IVA cervical cancer or stage II-IVA vaginal cancer. More than six medical centers in the U.S. are expected to participate. The primary endpoint of the study will be a metabolic response captured by the three month post-therapy 18-fludeoxyglucose (18F-FDG) PET/CT response. Secondary outcomes will include adverse events as well as clinical response as measured by RECIST (Response Evaluation Criteria In Solid Tumors) criteria and progression-free survival. The study is expected to complete in 2014.
Commenting on today’s news, Carl N. Kraus, M.D., Chief Medical Officer of Nanotherapeutics, noted, “We are delighted to announce that the first patient has been enrolled in this important NCI-sponsored study. Approximately 50% of the more than 12,000 American women diagnosed annually with cervical/vaginal cancer present with non-localized disease. Additional therapeutic options are needed for this group, and we are hopeful that Triapine® may positively impact the natural history of this disease for these women.”
In a previous Phase II trial of 25 subjects (22 of whom had locally advanced cervical cancer) Triapine® in conjunction with cisplatin and radiation showed a 100% complete response rate with no disease progression that was documented through 18 months of median follow-up. When completed, this latest Phase II study should provide the necessary data for a larger confirmatory trial.
“We are grateful for the sponsorship of the NCI and look forward to continued recruitment and development of this important compound,” said Dr. Kraus.
Triapine® is a small molecule that inhibits the enzyme, ribonucleotide reductase. Ribonucleotide reductase is essential for the synthesis of DNA and thus for replication of cancer cells. Because Triapine inhibits DNA synthesis, it can inhibit DNA repair, and therefore may increase the anti-tumor effects of many of the common anti-cancer drugs. Triapine® has potential to be used as a single agent and in combination with anticancer drugs to prevent damaged anticancer cells from regenerating. Intravenous formulation of Triapine® has been evaluated in five single agent Phase I trials, three single agent Phase II trials, four Phase I combination trials, and two Phase II combination trials. Clinical testing of new single agent administration schedules may be possible with the oral form of Triapine®, which to date has been studied in a small number of patients to determine its absorption in the bloodstream following a single dose.
About Cervical Cancer
There are more than 12,000 new cases of invasive cervical cancer diagnosed annually in the U.S. with nearly 4,000 deaths attributed to cervical cancer. In addition, more than 50,000 cases of carcinoma in situ are diagnosed each year. Internationally, 500,000 new cases are diagnosed each year. The annual incidence in the U.S. is 6.8 cases or less per 100,000 women, yet rates in parts of South America and Africa range as high as 52.8 cases per 100,000 women.
Nanotherapeutics, Inc. is a privately held biopharmaceutical company with a major focus on developing a diversified proprietary pipeline of products having both biodefense and medical applications. Products under development include biodefense medical countermeasures, CNS, wound healing, addiction and pain, oncology, anti-infectives, vaccines and orthopedics. The Company has one FDA cleared injectable biologic, NanoFUSE® DBM used by orthopedic surgeons as bone graft filler. Nanotherapeutics has in-house cGMP manufacturing, formulation, and expertise in pre-clinical and clinical product development as well as clinical trial management to support its products. Established in 1999, the Company employs several proprietary platform technologies to manipulate and enhance the properties of drug candidates. For more information, visit the Company website at www.nanotherapeutics.com.