The genomics revolution may not have ushered in the age of personalized medicine the way healthcare experts predicted, but
innovative diagnostics keep pushing the industry toward the ideal of the "right drug for the right person at the right time."
One company that exemplifies that model is CeMines, a Colorado-based enterprise with an impressive, noninvasive cancer diagnostic
in development. The product, which uses molecular fingerprinting to test blood samples, has had a 100 percent accuracy rate
for every trial conducted. It not only determines-even in early stages-if a patient has cancer, but provides guidance for
which type of treatment will work best.
Another extraordinary thing about the company is that neither Richard Cavalli, CeMines' president, or Bailey Dotson, its CEO,
has a pharma background. So how did two real-estate moguls get involved in a business based on transcription factors, molecular
fingerprinting, and auto-antibodies?
Chance and Chemistry
The company began the way many startups do, with a chance meeting between two innovative thinkers with the drive to combine
their ideas into a successful venture. In 1999, Cavalli, a Colorado businessman, met Tom Neuman, PhD, a molecular biologist
at Cedars-Sinai Medical Center in Los Angeles. Cavalli was fascinated by Neuman's 20 years of work in transcription factors
(proteins involved in gene expression), and Neuman was emboldened by Cavalli's confidence in his work.
The Minds Behind CeMines Richard Cavalli (left) founded CeMines on the strength of its lead scientis's work. Bailey Dotson
(right) came on board soon after and helped fund the company.
"So I just put it out to Tom that I was quite impressed with him," Cavalli recalls. "We seemed to have very good chemistry,
and we were able to put together a business plan and start CeMines." Named for "cellular mining," CeMines was found-ed in
April 2000 in Cavalli's hometown of Evergreen, Colorado. Cavalli's confidence also lead him to invest a half-million dollars
from a personal trust into the startup. Soon after, Bailey Dotson, Cavalli's business associate, came on board, and the two
men eventually funded the company with another combined half-million dollars from their real-estate development businesses.
But CeMines isn't dependent on its founders' faith and generosity. An additional source of funding comes from sales of reagents
to more than 150 research institutions worldwide, generating $1.2 million so far. CeMines was developing antibodies for its
own research and saw a business opportunity to offer unique reagents to other researchers. The company has also sold $1 million
in common stock.
"Our reagents business is increasing in size and number," Cavalli reports. "We have a very good reputation in the research
community for providing products that work very well. And we recently created partnerships with the top two industry leaders,
Sigma Aldrich and Chemicon International, that have boosted our sales significantly and have opened doors to future increases."
But of course, all that funding is for one greater purpose: to drive the development of the company's star project-blood tumor
Most cancer is currently detected through imaging or biopsies, both of which take place when the tumor is quite large and
difficult to treat. A few blood-based diagnostics for hormone-related cancers are on the market, such as the PSA test for
prostate cancer and the CA-125 test for ovarian cancer. Neither method is ideal or highly accurate. CeMines' technology combines
the best of both worlds. Tumors, which are homogenous in the early stages, develop subpopulations of malignant cells, which
trigger the body to produce unique auto-antibodies. The diagnostic tests the patient's blood against dozens of known cancer
antigens, looking for a reaction with cancer antibodies. The screening identifies the highly specific molecular subtypes of
cancer by analyzing a network of cell regulatory factors. In finding the tumor's cellular fingerprint in the bloodstream,
the diagnostic can detect the presence of cancer very early. And by testing it against dozens of antigens, the diagnostic
can determine which type of cancer is present. (See "The CeMines Technology.") Neuman, CeMines' chief scientific officer,
puts it simply: "There are hundreds of published papers in which people have shown that at the molecular level there are different
groups of tumors. Everybody can do it when they have a piece of tumor. What we can do is identify the different molecular
groups using noninvasive techniques."
But the technology goes beyond that. "It not only will provide the diagnosis, it will provide a description of the tumor's
structure at the molecular level so that targets can be drawn precisely," Cavalli says. "It will offer guided therapeutics,
because with a known molecular fingerprint, we can access a database that will show how each specific tumor has reacted historically
to specific treatment regimens."
The result is that the company will be able determine which treatment has worked well for that cancer subgroup before. That
is good news for patients, who often have to undergo multiple regimens. The diagnostic also allows oncologists to monitor
patients whose cancers come back. "What happens is that tumors change," Neuman says. "The patient has one tumor type right
now, and in two years, the same patient may have a modified type of the same tumor. So he actually needs a completely different
treatment strategy." »
Upside for Pharma
"The big payoff for the industry is in drug approval," Dotson says. "We believe the technology addresses two areas: the molecular
understanding of the tumor and how various drugs interact with it, both of which help determine what the side effects are.
We think there is an opportunity for pharma to take another look at some of the 400 or so drugs that didn't make it through
Phase III." In theory, using the test to screen trial subjects will allow cancer drugs in development to demonstrate greater
The CeMines Technology When the body detects an invader, such as cancer, the immune
system is called to action. By checking the blood for signs of such activity, CeMines' molecular
fingerprinting test can detect cancers in their earliest stages, allowing for more effective treatment.
Other good news for the industry is that CeMines' database of molecular cancer fingerprints will eventually allow pharma companies
to "design intelligent therapies that target specific signaling pathways," Neuman says. "That is our long-range goal," Dotson
adds, "to develop a whole new generation of more intelligently designed drugs that are really a rifle shot to the tumor rather
than the shotgun approach that we are forced to use today."
But all that is down the road. Short term, to get FDA approval, the company must conduct large-scale trials with 1,000 people
or more. And it may need an additional source of funding to make that happen. "Rather than looking to the market to raise
the money," Dotson says, "we are probably looking at partnering. We've had preliminary discussions with two or three major