New drugs undergo two types of testing. Initially, preclinical trials test whether a new drug is effective and safe in test tubes and in animals. Then, once preclinical trials indicate safety, clinical trials test the new drug in people. Clinical trials are normally divided into three phases. In Phase I, a few people are tested primarily for potential side effects. In Phases II and III, more people are tested to determine whether the drug is an effective treatment for the intended conditions and to continue monitoring side effects.

Separate from preclinical and clinical trials, there exists the possibility of compassionate use. Under federal compassionate-use laws, treatments which have successfully completed Phase I clinical trials may be offered to people with terminal illnesses.

Given the clear, positive results of our pilot tests (see Pilot Test Results), the Institute plans to move forward with FDA preclinical and Phase I clinical trials. We are raising money to fund this research (see Support Our Research).

After the successful completion of preclinical and Phase I clinical testing, Immudel-gp120 will qualify for compassionate use. We believe that compassionate use would be an appropriate way to make this drug available to some of the many people who cannot wait for full FDA approval.

As a research-based biotechnology firm, we ultimately expect to enter into licensing agreements with pharmaceutical companies for manufacturing and marketing. However, our vision is to fund or arrange funding for the complete clinical trials, and to license Immudel-gp120 as a generic drug as soon as possible. As a generic, free market competition will keep the cost down. We believe this will allow us to better meet our humanitarian goals, making Immudel-gp120 maximally affordable and accessible.

To facilitate our development process, we have filed for patent protection on the design of Immudel-gp120 and our other immune-modifying drugs.

If you are interested in helping our unique research to proceed as quickly as possible, please Support Our Research. We are a not-for-profit organization and rely on grants and charitable contributions to progress.

If you represent a pharmaceutical company interested in forming a strategic alliance to support the development of Immudel-gp120, or any of the other immune system drugs in our pipeline, please click here: For Pharmaceutical Companies.

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