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Hemispherx's Chronic Fatigue Drug Rejected by FDA


The agency says Ampligen needs additional testing to show that it works and is safe. The company says it will appeal the decision and implores hunger striker to start eating.

Hemispherx's (NYSEAMEX:HEB) drug Ampligen for chronic fatigue syndrome was rejected again by US officials, who said the treatment needs more study to show that it works and is safe.

The US Food and Drug Administration "said Hemispherx should conduct at least one additional clinical trial, complete various non-clinical studies, and perform a number of data analyses," Hemispherx says in a statement.

In other words, Ampligen is nowhere close to being approved. The FDA previously rejected the drug in November 2009, saying that the company didn't demonstrate in human studies that the drug worked to help chronic fatigue patients. The FDA is still not convinced, according to Hemispherx.

What's more, the company says it's going to appeal the decision. Hemispherx says it first wants to meet with FDA officials to "discuss the corroborating data and experiences of clinicians and patients who have seen the benefits of Ampligen therapy."

And, in the most unusual part of its statement, Hemispherx says a chronic fatigue patient began a hunger strike at the end of January to send a message to the FDA that people with the condition need an approved drug. A Reno, Nevada, man named Robert Miller reportedly went on a hunger strike beginning at the end of January, according to a local TV news report. The company didn't name the patient in its release.

"Hemispherx understands the frustration that there is still no FDA-approved treatment for (chronic fatigue syndrome) and the concern that patients may lose access to Ampligen therapy," the company says in a statement. "Out of concern for the health of the (chronic fatigue) community, Hemispherx has asked any hunger strikes be discontinued and that patients join in a collaborative effort between the FDA, Hemispherx, (specialist) clinicians, and patient advocates to find a solution to this significant unmet medical need."

The company calls out FDA Commissioner Margaret Hamburg by name, quoting her as saying that the agency has a role in making sure breakthrough medicines reach market. But the company decided it wasn't going to follow the agency's advice to run a new clinical trial after being rejected in 2009. In a statement posted on its website, the FDA said it worked with Hemispherx for years on a potential approval for Ampligen. In an appeal to chronic fatigue patients, the agency said the rejection of "Ampligen is entirely separate and distinct from FDA's support of drug development" to treat the disease. See the FDA's statement here.

In recent months, there was plenty of foreshadowing as to which way the FDA would rule on this drug decision. Agency staff ripped the company's data in a report just ahead of a panel review by a group of government advisers in December. (See also: Hemispherx Chronic Fatigue Drug Scrutinized Ahead of Panel Review.) The expert advisers subsequently voted that Ampligen shouldn't be approved because Hemispherx had not shown that the drug was effective.

In pre-market trading Tuesday, Hemispherx shares dropped 34% to $.17 each. The stock already lost almost 60% of its value since FDA staff questioned the drug's effectiveness in December.

Chronic fatigue syndrome is characterized by severe and constant tiredness. The cause of the disorder is not known and there is no cure. Some patients who become depressed or anxious are treated with drugs for those particular symptoms.

Twitter: @brettchase

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