CytoDyn Inc. (Pink Sheets: CYDY) is a development stage bio-technology company trying to develop 2 primary therapies. First is a trivalent DNA based pre-flu vaccine. In July 2006, the company acquired the exclusive right to develop a DNA based pre-flu vaccine from the University of Massachusetts.The firm hopes to enter Phase I trials sometime within the next 12 months. At this point, no investigational new drug application has been filed. Unlike other viruses, the flu virus changes every year causing an outbreak of seasonal flu. This requires a new vaccine each and every year once the new stain of influenza has been isolated. The company’s DNA Plasmid vaccine works with an injection containing viral DNA to “teach” the immune system how to recognize various strains of the new flu. This DNA vaccine will be used in conjunction with traditional viral based flu vaccines.
The key motivation behind this drug is to be prepared in case a bird-flu pandemic was to occur. According to health officials, the H5N1 avian flu virus (the strain that humans are susceptible to) has become resistant to existing anti-viral solutions. A DNA based cure can be injected anytime, even before any symptoms were to occur.
The firm’s other drug is Cytolin. Recently the company acquired the exclusive right to develop an improved version of Cytolin utilizing two antibodies invented at Harvard University Medical School’s CBR Institute for Biomedical Research. The drug is designed to be a “salvage therapy” for patients who have failed or are failing Highly Active Antiretroviral Therapy. The Phase I (b)/II (a) study has been completed, and the results justify a meeting with the FDA to gain permission to continue onto Phase II (b) trials.
The Phase I (b)/II (a) trials were conducted by Symbion Research under the sponsorship of Amerimmune during 2002. The company has purchased the data from these trials from Symbion which is to be used in their presentation to the FDA. An alternative to this data would be to use the new hybridomas obtained from Harvard’s CBR Institute. However, this would require a new Phase I/ II study.
For Cytolin, the price to obtain Symbion’s data was $362,000. It is estimated that if the FDA were to approve Phase II testing, an additional $6.1 million will be spent to execute the study. For the Phase I trials for the pre-flu vaccine, approximately $2 million of expenditures would be required.
