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Mesothelioma News | 2008
Madison, WI Biotech Firm Happy to Ride the Coattails of Competitor
Madison, Wisconsin - Is there a reason to be concerned at Madison-based Quintessence Bioscience? An East Coast biotech competitor Alfacell Corporation, just completed its second Phase III trial of a new class of anti-cancer therapy that is much like what is being developed at Quintessence, which has not even started clinical trials yet.
It doesn't show if, in fact, the folks at Quintessence are worried about being behind Alfacell.
President and chief operating officer, Laura Strong, and chairman and CEO, Ralph Kauten, are both very excited over the developments at Alfacell. They believe that Alfacell success will help with validating the new anti-cancer therapy under development at Quintessence. It will also smooth the regulatory issues that all new technologies face will help attract investor interest.
It is Ralph Kauten's belief that Alfacell's progress is a "great boon" for Quintessence. Although it appears that Alfacell is paving the way for Quintessence, some question whether Quintessence will really benefit from the success at Alfacell success.
New anti-cancer therapy
Both companies are targeting RNA in cancer cells in the novel therapies under development. While existing anti-cancer therapies target mostly the DNA or specific proteins in cancer cells, RNA, is produced by the genes and directs the production of a cell's proteins, and thus far has been an untapped target for killing off cancer cells.
Therapeutic ribonucleases (RNases), which are ubiquitous enzymes that destroy RNA are being developed by both companies. RNases have an important role in regulating gene expression in normal cells, where their activity is tightly regulated in order to guard against indiscriminate destruction of RNA that would result in unwanted cell death. It has been discovered that RNases from non-human species sometimes are not regulated inside human cells and can cause cell death by researchers, including Ronald Raines at the University of Wisconsin.
Interestingly, it has been found that cancer cells are much more vulnerable than normal cells to foreign RNases. Alfacell is taking advantage the anti-cancer activity of Onconase, an RNase purified from frog eggs. In the meantime, Quintessence utilized genetic engineering to create a designer RNase, QBI-139, that is 95 percent human, and it kills human cancer cells like the frog enzyme.
Various studies show that both Onconase and QBI-139 kill a wide variety of different types of human cancer while sparing normal cells. As a result, these RNases have exciting potential to broadly treat different types of cancers, which is in clear contrast to many other experimental therapies that narrowly target only certain types of cancer. The RNase therapy market potential could be enormous.
To date, the anti-cancer effects of Onconase have been reported for approximately 300 patients with differing types of cancer. Most of the data reported so far are for patients with malignant mesothelioma, a rare lung cancer that is very hard to treat. The most advanced cases of mesothelioma were not responsive to Onconase in the first phase III trial, but in patients with less advanced cancer the drug did increase life span.
The results for the recently completed phase III confirmatory trial for treating mesothelioma will soon be reported by Alfacell. Because the trial focused on treating patients with less advanced disease, the chances for seeing encouraging results are good.
Interestingly, Alfacell has entered marketing and distribution agreements in recent weeks for commercializing Onconase in the U.S., parts of Asia, and Eastern Europe. The company appears very optimistic that Onconase will soon become a widely approved orphan drug for the treatment of mesothelioma.
The Quintessence advantage
So why aren't the people at Quintessence discouraged? First, there is very strong science behind QBI-139 and it has promise to have a significant advantage over Onconase. Frog-derived Onconase caused allergic reactions in some patients in clinical studies and was poorly cleared by the kidneys, resulting in dose-limiting problems. In contrast, QBI-139 is unlikely to cause allergic or other immune problems because it is an engineered gene product that is 95 percent human.
In addition, as pointed out by Strong, animal studies reveal that QBI-139 is far less toxic than Onconase, and that will allow greater flexibility in dosing. Lastly, QBI-139 is reported to be approximately 100 times more enzymatically active compared to Onconase. Combined, these facts indicate that QBI-139 stands a very good chance of showing more impressive clinical results than Onconase and of being an efficient and flexible therapy.
A second generation QBI-139 product is also being developed by Quintessence that remains longer in the blood stream and therefore has an enhanced chance to attack cancer cells in the body. Strong is very excited about QBI-139 and submitted a second-level Small Business Innovation Research application recently to the National Institutes of Health in an effort to continue product development.
She said, "Things are really working well."
QBI-139, at this point, is in production to be used in a Phase I clinical trial that is anticipated to start this summer and end sometime in 2009. Indications are that this trial will be take place at the Carbone Cancer Center at the University of Wisconsin.
What is next?
What does Quintessence do next assuming that the Phase I trials yield encouraging results?
"It will be hard to develop a new cancer company in Wisconsin. We will obviously need to partner and probably before Phase II (trials)." opined Kauten.
The underlying sentiment was that Wisconsin lacks the necessary infrastructure to take a successful therapeutic drug to the market from a mid-research stage.
Wisconsin's desire to become a major player in the biotech arena is hindered by this unfortunate problem. If good biotech ideas, of which there are a good number in Wisconsin, cannot withstand development beyond early clinical trials, much less be produced and marketed here, and Wisconsin becomes simply an incubator for West and East coast concerns. Even though ideas are born and tested here, they are brought to fruition on the East and West coasts.
2009 could mark the beginning of Quintessence's Phase II trials, which means that the company is likely to form a partnership with a pharma company in the not-too-distant future. Quintessence's success will result in it's looking beyond the Wisconsin borders.
