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. - Pre-clinical toxicology data indicates that the lead cancer drug candidate of Madison's Quintessence Biosciences
has met two important preconditions set by the Food and Drug Aministration
for being tested on cancer patients.
The data, which was presented at the annual meeting of the American Association for Cancer Research
, demonstrates the drug, QBI-139, can be manufactured on a large scale and applied in safe doses, the company announced.
Quintessence, a biopharmaceutical company focused on developing protein-based cancer therapies, hopes to test the drug on cancer patients with solid tumors.
CEO Ralph Kauten noted the company previously demonstrated the efficacy of QBI-139 in inhibiting tumor growth. More recently, it has proven the drug can be manufactured on a large scale, both repeatedly and reliably, and has identified a safe dosage that will provide efficacy.
The next step will be to apply to the FDA for permission to hold Phase I clinical trials where the drug will be tested on cancer patients.
Kauten said the company has scheduled a meeting with the FDA, and expects to begin the Phase I trial on about 30 cancer patients in early 2008.
This is a long and slow process, but for a good reason, Kauten said. The FDA wants to make sure people are well prepared.Taking on all comers
According to Kauten, Phase I will be an all comers trial, meaning it will be open to patients with a variety of cancers, including lung, ovarian, pancreatic, or colorectal cancer.
Based on the results of Phase I, Kauten said a subsequent phase would test QBI-139 on a more specific cancer.
As the company's lead cancer drug, QBI-139 represents the first in a series of oncology products advancing from the company's EVade ribonuclease development program.
The AACR meeting provides Quintessence with an opportunity to report information on its emerging drug candidates, and perhaps establish collaborations with groups interested in developing cancer drugs.Related stories
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Quintessence cancer treatment chosen for clinical studies
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Quintessence division to develop drug tests with NIH grant