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Performance of Second 50 Completed ATP Projects — Status Report Number 3 NIST Special Publication 950-3 (January 2006)
Current Methods Only Treat Symptoms of the Virus As anyone who has had the flu knows, antibiotics do not work on viruses. Typically, medical professionals can only treat a patient's fever, sore throat, and cough while the virus runs its natural course through the body. Similarly, treatment for the viruses C. parvum and human rotavirus, which cause viral gastroenteritis, involved only treating the symptoms of the ailment. Improvements in virus treatments could not be made unless methods of actually killing the viruses themselves were found, which was the focus of GelTek's proposed research. Killing Viruses Marks a Major Shift for Medical Treatment GelTex developed a program to research molecular recognition polymers that would act as anti-infectives, binding to the viruses, neutralizing them, and passing them harmlessly through the gastrointestinal tract. Viruses attack by attaching to human cells at specific points, injecting viral ribonucleic acid (RNA) into the human cell where the RNA replicates, forming new viruses, and then moving on to infect other human cells. The proposed anti-infectives would be engineered with an outer "skin" of receptors that would bind to a virus, occupying the very receptors that bind to and infect human cells. These polymers would be used to neutralize the reproduced viruses, preventing their continued onslaught on the human body. Unable to bond with and infect new cells, the neutralized viruses would either be passed out of the body through waste products or would die inside the body without infecting new cells, thus allowing the patient to recover much faster. Anti-Infective Technology Could Save Billions of Dollars In the early 1990s, the healthcare industry projected that the successful treatment of C. parvum could save the nation $135 million annually. Moreover, since rotavirus affects 3.5 million American children annually, better treatment could generate savings of up to $1 billion in treatment costs and economic losses from parents' lost work time while caring for their children. If this research program proved successful, the next step would be to neutralize other viruses that could result in much greater savings for the U.S. economy. Therefore, ATP awarded GelTex $2 million to conduct research with the goal of eliminating viruses through the development of its anti-infectives. Healthcare Industry Concerns Cause Early Termination of Research During the ATP project, a number of changes in the healthcare industry required that GelTex redirect its research. In the second quarter of 1996, GelTex discovered that a pharmaceutical company was making rapid progress toward introducing a vaccine that would limit the market for an oral rotavirus treatment. At the same time, GelTex was making rapid progress toward developing the C. parvum anti-infective. As a result, the company directed its resources away from rotavirus and toward its C. parvum program .Improvements in virus treatments could not be made unless methods of actually killing the viruses themselves were found. By May 1997, GelTex had identified three lead compounds with which to conduct final C. parvum testing, but again the market shifted in an unfavorable manner for GelTex. The "drug cocktail" of protease inhibitors for HIV/AIDS patients became available in mid-1997. This combination therapy drastically reduced the incidence of C. parvum infections among HIV/AIDS patients. With fewer patients catching the virus in the first place, the potential market for a C. parvum anti- infective shrank to the $25 million to $75 million range. Based on costs to get a drug through the lengthy Food and Drug Administration trials process, this market was too small for investors to pursue. Therefore, with three months remaining on the ATP project, GelTex ceased work on its anti-infective for C. parvum. ATP Award Leads to External Funding ATP funding lent credibility to GelTex's efforts and aided in attracting additional capital. One year after the initiation of its ATP project, GelTex went public. The company continued to fund infectious disease research after the ATP award ended, more than doubling the staffing level for the program to 14 full-time equivalents. In 2000, GelTex was acquired by Genzyme, and the combined firms used the knowledge that GelTek had gained during the ATP project to continue their drug development efforts. Conclusion ATP awarded cost-shared funds to GelTex in order to implement a research plan to develop an "anti-infective" that would eliminate viruses from the human body rather than just treating the symptoms. The healthcare industry and the U.S. economy as a whole stood to benefit from a successful research effort through more effective healthcare and fewer work days lost to illness or time spent caring for sick children. From human rotavirus alone, the economic benefits from successful treatment could reach $1 billion. Despite this promising beginning, various changes in the healthcare marketplace led GelTex to abandon its research. Other treatment options for the two viruses tested during the research project entered the marketplace, diminishing the possibility for successful commercialization. After GelTek was acquired by Genzyme in 2000, the knowledge gained from the ATP- funded research assisted the companies' continued drug development efforts.
Research and data for Status Report 94-01-0147 were collected during January - March 2002. Return to Table of Contents or go to next section of Status Report No. 3. Date created: April 4, 2006 |
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