Nanotherapeutics Acquires Two Cancer Treatment Agents in Late Stage Development for Relapsed AML and Cervical and Vaginal Cancers

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Nanotherapeutics acquired two cancer treatment drugs that are in late stage development. Cloretazine®, formerly known as Onrigen™ for the treatment of relapsed acute AML and Triapine® for solid tumors such as cervical and vaginal cancers.

Nanotherapeutics, Inc., a privately held biopharmaceutical company, announced that it has acquired two late stage oncology clinical programs: Cloretazine®, formerly known as Onrigen™, an agent for the treatment of relapsed acute myelogenous leukemia (AML) and Triapine® a small molecule for treating solid tumors such as cervical and vaginal cancers. The compounds were discovered in the laboratory of Alan Sartorelli, Ph.D. and originally licensed to Vion Pharmaceuticals, Inc. by Yale University. Nanotherapeutics also acquired the U.S. and foreign patent estates covering each clinical program and will continue developing the clinical programs for drug approval.

Cloretazine® has been evaluated in Phase 3 trials and a new drug application (NDA) has been filed with the FDA. More data will be acquired in additional Phase 2/3 clinical trials. The National Cancer Institute through the Cancer Therapy Evaluation Program (CTEP) has sponsored 19 studies involving Triapine®.

Positive interim results from a Phase 2 trial evaluating Triapine® in conjunction with the standard of care, cisplatin and radiation, for locally advanced cervical and vaginal cancer were presented at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting. In the ten patient study, a 100% complete response rate was observed and no disease progression was documented through 18 months of median follow-up. Cervical cancer is the second most common malignancy in women worldwide, and it remains a leading cause of cancer-related death for women in developing countries.

About Cloretazine® and AML

Cloretazine® is a novel sulfonylhydrazine alkylating agent that damages DNA and results in cell death. Alkylating agents are generally known to be among the most highly effective agents in the treatment of cancer. Acute myeloid or myelogenous leukemia (AML) is cancer that starts inside bone marrow, the soft tissue inside bones that helps form blood cells. The cancer grows from cells that would normally turn into white blood cells. It is the most common type of leukemia in adults, with an estimated 11,000 new cases of AML reported each year. AML is rare under age 40 and generally occurs around age 60. It is more common in men than women.

About Triapine®

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 1 trials, three single agent Phase 2 trials, four Phase 1 combination trials, and two Phase 2 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.

There are more than 12,000 new cases of cervical cancer diagnosed annually in the U.S. 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.

About Nanotherapeutics

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, CNS, wound healing, addiction and pain, oncology, anti-infectives and orthopedics. The Company has one FDA-approved 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 eleven years ago, the Company employs several proprietary platform technologies to manipulate and enhance the properties of drug candidates. For more information, visit the Company website at http://www.nanotherapeutics.com.

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Gary A. Ascani
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