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 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® 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®

• 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 over 40 patented cyanoaziridines (Amplimexon analog) 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®:

   

  Protocol No.	Phase	Combination with	Target	Status	Results
  AMP-001	I	None	Metastatic Cancer	Completed	Response In Lymphoma
  AMP-011	I	None	Metastatic Cancer	Completed	MTD Established
  AMP-007	I	None	Multiple Myeloma	Completed	No Responses
  AMP-005	I/II	DTIC	Malignant Melanoma	Completed	Prolonged Survival
  AMP-004	I	Gemzar	Pancreatic Cancer	Completed	Responses Noted
  AMP-010	I	Taxotere	Lung, Breast, Prostate Cancer	Completed	Responses In Lung and Prostate
  AMP-019	II	Gemzar	Pancreatic Cancer	Ongoing	Survival Endpoint early 2010
  AMP-024	II	Taxotere	Lung Cancer	Planned	-
  AMP-008	II	DTIC	Malignant Melanoma	Planned	-

 

Benzimidazole Series

• Benzimidazole Series: The benzimidazole analog series represents a group of about 20 novel small molecules with distinct structures from previous benzimidazoles that expressed tubulin binding activity in yeast and mammalian cells. The new analogs (the AMP-500 series) are small molecules (< 500MW), synthesized in AmpliMed'slaboratory under Professor Remers direction. Design criteria involved good water solubility and unique structures from prior benzimidazole agents. Some of these analogs
  have shown anti-tumor efficacy in vitro against human tumor cell lines. A lead analog, AMP-507, has been selected for further preclinical development based on its favorable activity profile in preclinical experimental tumor models. Preliminary mechanism of action studies suggest that these newer analogs have a actions that are distinct from prior benzimidazoles used as anticancer agents.

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.