The results of Alfacell Corporation's Phase IIIb clinical trial for the mesothelioma treatment Onconase has been released this morning.

Onconase is a drug therapy using enzymes from frogs to interact with human RNA to treat cancer. The press release stated that the treatment did not significantly help patients whose mesothelioma could not be surgically removed, but it did help patients for whom chemotherapy did not work. Now, Alfacell is applying Onconase for FDA approval in order to help mesothelioma patients who are not compatible with chemotherapy. According to the press release, there is currently an "unmet medical need" among these patients.

Onconase has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, it is in initial stages of marketing in the European Union. Alfacell believes it will file the New Drug Application with the FDA by the end of this calendar year.

"I am pleased that we have reached this important milestone for both Alfacell and ONCONASE," said Kuslima Shogen, Alfacell's chief executive officer. "We are deeply appreciative of the cancer patients and clinical investigators who participated in this important trial."

To listen to a webcast regarding the press release, click here. The full press release can be found at this link.

In the race for a novel anti-cancer therapy drug between two firms, one company is clearly ahead.  Alfacell Corp., an east-coast biotech company, is in its second Phase III trial for a drug that uses an enzyme to interact with RNA to treat cancer.  Quintessence Bioscience, of the midwest, is developing a very similar drug, but has yet to even begin trials.  Quintessence is not concerned by their speedy competition, however.  On the business side of things, they believe attention garnered by Alfacell will help raise confidence in the Quintessence approach, encouraging investors to buy stock.  On the scientific side, Quintessence believes their product will be safer and more effective.

The two companies have comparable intentions, but different executions.  Alfacell is using an enzyme from frog eggs called Onconase, whereas Quintessence is using an engineered enzyme known as QBI-139.  When administered to mesothelioma patients, Onconase showed no effect on those with advanced disease, but it did increase the lifespan of patients in early stages of mesothelioma.  Because it comes from frog eggs, however, Onconase can spark allergic reactions and needs to be administered in closely-monitored doses.  Nevertheless, Alfacell is confident their drug will receive approval, and the company has already entered marketing contracts overseas.

Quintessence, hardly wary of their competitor's progress, believes more strongly in their own product.  QBI-139 is over 100 times more active that Onconase, is significantly less toxic, and because it is synthetic, can be administered with more dosage flexibility.  Furthermore, the enzyme stays in the bloodstream longer than Onconase, enabling it to fight metastasized cancers. Quintessence believes the product will enter Phase I trials on mesothelioma patients this summer.  Read the full article here.