Alios Therapeutics

Fig. 17.4 The comparison of the costs of several blood substitutes companies to develop an oxygen carrying molecule vs. the Alios Therapeutics Inc. allosteric effector RSR 13 to an IND and phase one clinical trial.

Alios Therapeutics Inc. was then able to proceed through a phase-one study on the basis of the basic and preclinical studies for only 2 million. This is perhaps a record for a new drug. The following graph prepared by the former Alios CEO, Stephen Hoffman, compared the cost of development of RSR 13 to the blood substitute companies that also sought to increase oxygen delivery in vivo (Figure 17.4). 

Alios Therapeutics Inc. and Clinical Trials with a Submission of an NDA... 

CEO, Stephen Hoffman and VP for clinical studies, Michael Gerber of Alios Therapeutics guided RSR 13 through a series of phase-one and phase-two clinical trials for radiation treatment of brain tumors and for potential use in cardiopulmonary bypass surgery [46, 51-55]. Considering the cost of running a phase-three clinical trial, only one was possible. The very positive phase-two results for use of RSR 13 to treat metastatic brain cancer provided the impetus for selecting that indication for a phase-three trial. 

The phase-three results were unblinded in March 2003 and overall, for all types of metastatic brain cancer, were reported as nonpositive, showing the drug to have efficacy but not at the statistical level set at the beginning of the trial by Alios Therapeutics Inc. for a successful phase-three trial. The subset analysis for the different types of metastatic cancer to brain, however, showed that breast cancer patients had a 100% increase in survival. The 500 plus patient trial also demonstrated RSR 13 to be extremely safe, confirming our early design feature of using a known antilipidemic drug, clofibrate, as a substructure. An NDA for RSR 13 with trade name efaproxaril was reviewed by the PDA on a fast track review for use in treatment of metastases of breast cancer to brain. 

D. Abraham, R. Danso-Danquah, T. Boyiri, I. Nnamani, C. Wang, M. Gerber, S. Hoffman and G. Joshi, Alios Therapeutics, Inc. Virginia Commonwealth University, WO 1999/048490. 

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