Gene Patent Healthy for Introgen
URL: http://www.wired.com/news/technology/0,1282,42069,00.html
Date accessed: 01 March 2001
2:00 a.m.
Feb. 28, 2001 PST A small Texas company has been granted a patent for a crucial technology used
by dozens of companies for gene therapy experiments. The U.S. patent
could mean that companies such as Pfizer (PFE)
and Schering Plough (SGP)
will find themselves paying royalties to Introgen
(INGN) of
Austin, Texas. Introgen's stock rose 13 percent following the news on Tuesday.
The patent is related to commercial purification and production of the
so-called adenovirus, which is a vehicle researchers use to carry healthy
genes into patients in gene therapy trials. Introgen's vice president of
intellectual property said the company will look for potential licensing
opportunities. "We expect that companies will have an interest in talking to us once
they have picked themselves up off the floor. They know our phone
number," said David Parker, vice president of intellectual property at
Introgen. One analyst said landing the patent looks good for Introgen. The adenovirus
vector is used in about 25 percent of gene therapy studies, second only to the
retrovirus which is used in 38 percent of trials. The payment of licensing fees could become a major issue for companies such
as Onyx Pharmaceuticals (ONXX),
which has been using the vector for years and is now in the final stages of
FDA clinical trials with their gene therapy for head and neck cancer. An Onyx
spokeswoman said lawyers at the company had not yet reviewed the patent. Other companies that use the adenovirus vector include Cell
Genesys (CEGE)
and Genzyme (GZMO). Cell Genesys spokeswoman Jennifer Williams said the company uses four types
of vectors for their gene therapy research, and the adenovirus is only third
on the list in order of importance. The company's most important vector, she
said, is a so-called adeno-associated virus (AAV). Williams also said that Cell Genesys has the largest patent portfolio in
the gene therapy industry. Researchers at Schering-Plough are using the adenovirus in phase 2 trials
on the treatment of ovarian cancer, but a company spokesman said
Schering-Plough has its own patents on its gene therapy technique. "There are a number of gene therapy products that have been developed
using adenovirus vectors and they're all different. There are numbers of ways
of altering the adenovirus to serve as your vector," said Bob Consalvo, a
spokesman for Schering-Plough. The adenovirus is popular with gene therapy researchers for several
reasons, Parker said. First, it can be made in reasonably large quantities for
a small amount of money. It also has shown few side effects in the
approximately 500 patients Introgen has treated using the adenovirus. The adenovirus was singled out as the cause in the first death to result
from gene therapy in September 1999. However, the method used to deliver the
treatment was considered very risky. Instead of delivering the gene therapy
into a tumor like Introgen and most other gene therapy researchers, University
of Pennsylvania investigators injected the adenovirus directly into
18-year-old Jesse Gelsinger's liver. He died four days later. The FDA has since banned
Penn's Institute for
Human Gene Therapy from doing experiments on humans, and in December the
agency threatened
to ban the researcher in charge of the institute from further human clinical
trials. Many researchers say Gelsinger's death was tragic but an isolated incident.
About 3,000 patients total have been treated to date using the adenovirus
vector without the complications seen in Gelsinger's case. "I think the fact that (there was) one questionable outcome in an
academic environment that was kind of out there on the fringes is a pretty
good record overall," Parker said. Parker touted Introgen's own gene therapy method, saying the company has
been held up as a "poster child" by the FDA as an example of how
gene therapy should be done. Introgen was the first company to bring a gene therapy for cancer to phase
3 clinical trials in head and neck cancer, which is the final stage of
research in FDA testing. Onyx and Vical (VICL)
have since also entered into phase 3 trials. Parker wouldn't comment on preliminary phase 3 results but said he would be
"very pleased if the results came back the same as in phase 2." Related
Wired Links: Categories: 18. Value of
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