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Pharma Regulatory updates

1/1/2010

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Safety review board recommends Vical continue trial of cancer drug candidate. A safety review board recommended" that Vical Inc. "continue a late-stage clinical trial of its cancer drug candidate Allovectin-7 and is expecting a full complement of 375 patients to be enrolled in the Phase III trial" of the melanoma vaccine "in the next few weeks “ according to the company.

Artemisinin-resistant malaria found near Thai-Cambodian border.
The American Press mentions that there is a "spot on the Thai-Cambodian border [that] is home to a form of malaria that keeps rendering one powerful drug after another useless." Now, "scientists have confirmed the first signs of resistance to the only affordable treatment left in the global medicine cabinet for malaria: Artemisinin." In addition to this emergence, "after decades of the overuse and misuse of antibiotics, diseases like malaria, tuberculosis, and staph have started to mutate. The result: The drugs are slowly dying."

More XXDR-TB cases may be unaccounted for, experts suspect.
A case of extremely drug-resistant tuberculosis -- being referred to as XXDR-TB -- in Florida is one of only a handful reported worldwide," and "there may be many more, according to Dean Schraufnagel, MD, a TB expert at the University of Illinois in Chicago and president-elect of the American Thoracic Society." The surge could be attributed to the fact that "first-line medications are not used properly." But, "what is 'worrisome' about the Florida case, Schraufnagel said, is that" the patient "had reportedly not been previously treated for TB, which might mean he contracted the strain from someone else."

Emergence of drug-resistant E. coli strain causes concern.

"First-line use of carbapenem antibiotics for urinary tract infections may become necessary if the spread of drug-resistant E. coli continues, a prominent infectious disease expert warned." According to Johann Pitout, MMed, of the University of Calgary, "an E. coli strain expressing a beta-lactamase enzyme known as CTX-M-15 has suddenly emerged in community-acquired infections worldwide." Pitout pointed out in his paper in Faculty of 1000 Medicine that "this strain is among the most worrisome of a series of recently emerging, community-acquired E. coli clones," because the "so-called extended spectrum beta-lactamases" may "break down cephalosporin and monobactam antibiotics which have been first-line treatments for" UTIs. 
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