Vion Pharmaceuticals, Inc.

Home > Products & Pipeline > Cloretazine® (VNP40101M)

Glossary

Site Map



ABOUT VION	PRODUCTS & PIPELINE	CLINICAL TRIALS	INVESTOR RELATIONS

Cloretazine® (VNP40101M)

Triapine®

Cloretazine® (VNP40101M)

Cloretazine® (VNP40101M) is a novel alkylating agent that is being evaluated for the treatment of acute myelogenous leukemia (AML), in a pivotal Phase 2 trial in elderly de novo poor-risk AML. In addition, three clinical trials of Cloretazine® (VNP40101M) are underway in: (i) elderly AML and myelodysplastic syndromes in combination with cytarabine; (ii) brain tumors in combination with temozolomide; and (iii) advanced hematologic malignancies in combination with hematopoietic cell transplantation.

Q. What is Cloretazine® (VNP40101M) and how does it work?

A: Cloretazine® (VNP40101M) is a small molecule that works by damaging DNA. Cloretazine® (VNP40101M) releases the DNA chloroethylating agent 90CE after entering the blood stream. 90CE chloroethylates the O6 position of guanine residues, ultimately resulting in an interstrand DNA cross-link. Interstrand DNA cross-links are difficult to repair and are toxic to cells. Cloretazine® (VNP40101M) demonstrated a broad spectrum of anticancer activity in preclinical studies, including activity in selected cell lines resistant to other alkylating agents such as BCNU, cyclophosphamide and melphalan. In preclinical studies, Cloretazine® (VNP40101M) has been combined with other anticancer agents such as cytarabine (Ara-C). In addition, Cloretazine® (VNP40101M) or its metabolite, has been shown to be capable of crossing the blood brain barrier in preclinical models.

Q. In what clinical trials is Cloretazine® (VNP40101M) being evaluated?

A: Cloretazine® (VNP40101M) is being evaluated for the treatment of acute myelogenous leukemia (AML) in a pivotal Phase 2 trial in elderly de novo poor-risk AML. In addition, three clinical trials of Cloretazine® (VNP40101M) are underway in: (i) elderly AML and myelodysplastic syndromes in combination with cytarabine; (ii) brain tumors in combination with temozolomide; and (iii) advanced hematologic malignancies in combination with hematopoietic cell transplantation.

Below is a table with a list of all completed, closed and ongoing Cloretazine® (VNP40101M) clinical trials.

Trial	Indication	Sponsor	Commencement Date	Status
Phase III trial in combination with Ara-C	AML, relapsed	Vion	March 2005	Clinical hold lifted by FDA; New Phase III trial in development
Phase II single agent trial	AML, elderly poor-risk	Vion	May 2006	Ongoing
Phase II single agent trial	Small cell lung cancer	Vion	September 2005	Closed
Phase II single agent trial	Brain tumors, adult	Investigator	June 2004	Completed
Phase II single agent trial	AML and high-risk myelodysplastic syndromes, elderly; AML, relapsed	Vion	March 2004	Completed
Phase I/II trial in combination with cytarabine	Elderly AML and MDS	Investigator	May 2008	Ongoing
Phase I/II trial in combination with temozolomide	Brain tumors, adult	Investigator	September 2007	Ongoing
Phase I/II single agent trial	Chronic lymphocytic leukemia	Vion	July 2005	Closed
Phase I trial in combination with stem cell transplantation	Hematologic malignancies	Investigator	November 2007	Ongoing
Phase I trial	Brain tumors, pediatric	Investigator	April 2005	Completed
Phase I trial in combination with temozolomide	Hematologic malignancies	Vion	October 2004	Completed
Phase I trial in combination with Ara-C	Hematologic malignancies	Vion	July 2003	Completed
Phase I single agent trial	Solid tumors	Vion	February 2003	Completed
Phase I single agent trial	Hematologic malignancies	Vion	August 2002	Completed
Phase I single agent trial	Solid tumors	Vion	June 2001	Completed

We hope we have provided you with answers to some of your questions. If you have a specific question please contact us.