AmpliMed FactSheet, AmpliMed is a cancer research chemotherapy corporation with a drug class that features novel mechanisms of action that can defeat MDR and some toxicities

Fact Sheet.

The Company:

AmpliMed Corporation is a University of Arizona-based, Arizona Board of Regents-approved pharmaceutical company, located in Tucson, Arizona. It was founded in 1989 with the support of The University of Arizona Technology Development Corporation to discover, develop and commercialize novel compounds for the treatment of cancer.
The company was formed by senior faculty members at the Arizona Cancer Center (AZCC) in Tucson, Arizona.
The company's anticancer drugs exhibit novel mechanisms of action designed to overcome some of the limitations, such as myelosuppression (suppression of the blood counts), multi-drug resistance (MDR is treatment-induced resistance to many cancer drugs) and other toxicities associated with some current cancer therapy.
The company's lead drug, Amplimexon® (imexon, inj.), is effective at killing cancer cells as a result of a unique mechanism of action that results in the buildup of toxic substances inside cancer cells exposed to the drug, ultimately resulting in a process known as apoptosis, or programmed cell death.

Drugs under Investigation :

Amplimexon

Two Phase I trials of AmpliMed's first drug, Amplimexon®, as monotherapy using two different schedule of treatment have been completed and the pharmacokinetics and safety profile of the drug as a monotherapy have been established. The results suggested that the drug is well tolerated as a monotherapy when administered as a 1 hour infusion daily for 5 days every 2 or 3 weeks, and showed signs of clinical benefit in patients with several different types of cancer.
Additional Phase I and Phase II trials in patients with pancreatic adenocarcinoma, malignant melanoma, lung, breast and prostate cancer are underway or have been completed, and have indicated future development pathways and the design of definitive clinical trials.
AmpliMed has obtained orphan drug designation for Amplimexon for several indications, including malignant melanoma, pancreatic adenocarcinoma, multiple myeloma and ovarian cancer in the U.S. and for pancreatic cancer and ovarian cancer in Europe.
The company has 30 patented cyanoaziridines (Amplimexon analogues) which share Amplimexon's favorable toxicity profile and have shown potent anticancer activity in preclinical systems.
The table below lists AmpliMed's protocols for Amplimexon®:

Benzimate Analogues

In August 2005 the company in-licensed a second drug, benzimate, from UTR. Scientists at the University of Arizona successfully developed a proprietary formulation of benzimate with substantial increased bioavailability compared with a prior formulation which had been the subject of early stage clinical studies carried out by The Procter and Gamble Company. Benzimate entered a dose-escalation Phase I clinical study in order to establish the pharmacokinteics and safety profile of the drug in cancer patients. The bioavailability of this formulation was not adequate. Therefore, the clinical trial was closed. A series of benzimate analogues and prodrugs are under development.

Amplizone™

Amplizone®, the company's third drug candidate, is a proprietary small molecule selected for clinical development from the company's novel azonafide series of compounds, discovered and synthesized at The University of Arizona. Initial target diseases for Amplizone® will be drug-resistant ovarian and breast cancer. In preclinical work, it was shown that Amplizone® overcomes MDR and the cardiotoxicity which is common in this class of drugs. The Company's portfolio includes 150 patented azonafides among which are many novel compounds ready for further preclinical and clinical development.