) --Another experimental lung cancer drug came up short Monday.
Small British drug maker
shut down a phase III study of its lung cancer drug ASA404 after an interim analysis revealed little chance that the drug would prolong survival, the company said.
Antisoma licensed ASA404 to Novartis, which will now review the drug's future but will likely halt development, Antisoma CEO Glyn Edwards told Reuters.
Antisoma shares plunged 70% in European trading.
The setback for ASA404 in non-small cell lung cancer comes soon after two other drugs for non-small cell lung cancer from
, respectively, also failed phase III studies.
The ASA404 phase III study enrolled patients previously untreated for non-small cell lung cancer, randomizing them to ASA404 plus chemotherapy or chemotherapy alone. The study's interim analysis showed the study to be futile, which means ASA404 treatment was unlikely to help lung cancer patients live longer.
Antisoma had high hopes for ASA404 because an earlier, randomized phase II study demonstrating that patients treated with ASA404 plus chemotherapy reported a median overall survival of 14 months compared to patients treated with chemotherapy alone who had a median overall survival of 8.4 months.
Antisoma is also testing leukemia drug ASA1413 in a phase III study.
Arca BioPharma Patent Deja Vu
(At 6:01 AM EDT)
Wacky, inexplicable things sometimes happen to biotech stocks. Like Friday, when
shares more than tripled after the small drug company was granted a new U.S. patent for its experimental heart failure drug.
Arca shares rose an astonishing $5.57, or 210%, to close Friday at $8.22. Calculated another way, one U.S. patent for Arca added $40 million in market value.
Not bad, especially considering Friday's announcement wasn't particularly new. Arca issued a press release in January announcing the U.S. Patent and Trademark Office had informed the company that the patent was coming. Friday's press release simply confirmed that the patent had been issued.
In case you're wondering, Arca shares rose just 17 cents as a result of the January press release.
So, what made Arca rocket Friday when it barely budged in January on the same patent news?
Like I said, some things in biotech defy logic. Fundamentals had nothing to do it, clearly. Instead, Friday's move was more likely a function of momentum traders finding an easy plaything in Arca, which sports a tiny float of just 4.4 million shares.
More than 49 million Arca shares traded hands Friday, or seven times the number of shares outstanding.
It was little noticed Friday, but Arca actually disclosed some bad news regarding the development of its heart failure drug bucindolol. Arca and the U.S. Food and Drug Administration have still not come to agreement on a Special Protocol Assessment for a proposed phase III study of bucindolol. Arca said Friday it had to submit revisions to the design of the study, which will now enroll 3,200 heart failure patients, up from 3,000 patients previously.
Arca needs FDA sign off on the bucindolol trial design, after which the company needs to raise money to conduct the trial. Arca says it can likely start the pivotal bucindolol study one year after both those things happen. The company expects the study to take two years to complete once fully enrolled.
As of December 31, Arca had $7.8 million in its coffers.
Arca is developing bucindolol with a companion genetic test that will help doctors determine which heart failure patients are likely to respond to treatment with the drug. The FDA refused to approve bucindolol last year, forcing Arca to conduct the new clinical trial.
-- Reported by Adam Feuerstein in Boston.
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