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Drug clinical research updates

1/4/2010

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First human trial begins on alternative to insulin injection.
Novo Nordisk A/S started the first human tests on an experimental insulin pill, joining companies seeking to develop an alternative to daily injections for diabetics who need the hormone to control their disease." The trial of 80 patients will attempt to "determine whether the medication is safe and how it works in the human body." In addition, Biocon Ltd. "said in September it plans to begin commercial production of an insulin pill within 18 months."

Carfilzomib meets study goals in treating patients with multiple myeloma.
Onyx Pharmaceuticals Inc.'s carfilzomib "worked in patients with multiple myeloma," according to a study presented at the American Society of Hematology meeting in New Orleans. The study of "51 patients who didn't respond to as many as three previous therapies" showed that "carfilzomib significantly reduced the disease in 45 percent of subjects, including one whose cancer disappeared." The drug "also helped reduce neuropathy," and Onyx's CEO said the study's "data also positions the company to enter the $4 billion myeloma market as soon as 2011 if US regulators evaluate the drug under an accelerated six-month review process."

Glaxo suspends Promacta chronic-liver disease trial.
After winning FDA approval as a treatment for chronic immune thrombocytopenic purpura, GlaxoSmithKline PLC (GSK) decided to look for other uses for Promacta [eltrombopag]. It was thought the blood-disorder drug could benefit chronic-liver disease patients who might need platelet transfusions during invasive treatments. Sometime in September, however, an independent panel reviewing the Elevate study found that there was an "increased risk of thombrotic and thrombo-embolic events" among seven of the 260 participants enrolled in the trial. Accordingly, the trial was suspended. GSK, however, continues to look for other applications among other patient groups, including those with hepatitis C and cancer.

Researchers examine antiepileptic medications, suicide attempt link in BD patients.
According to a study "of 47,918 patients with bipolar disorder (BD)" published in the Archives of General Psychiatry, those "who took one of 11 antiepileptic medications had the same rate of suicide attempts -- 13 per 1,000 patients per year -- as those who didn't take any drugs for their condition. That rate was slightly lower than for bipolar people who took lithium (18 suicide attempts per 1,000 patients per year)," and "was also much lower than the rate of suicide attempts among" patients with bipolar disorder "in the year before they began taking antiepileptic medications (72 per 1,000 patients per year)."

Two thirds of patients with SIE prescriptions may not use it before ED visit.
A 42 responses survey to a Mayo Clinic questionnaire revealed that "nearly two thirds of patients with prescriptions for self-injectable epinephrine (SIE) failed to use it before reaching the emergency department." What's more, "slightly more than half of those surveyed (22 individuals) reported a delay in coming to" the ED, "with 15 saying they expected the symptoms to go away. However, the severity of an anaphylactic reaction is impossible to anticipate, and treatment could come too late," explained lead author Wyatt W. Decker, MD.

Patients with indolent lymphoma may achieve long-term survival with tositumomab.
According to research presented at the American Society of Hematology meeting, "Patients with indolent lymphoma whose disease has progressed after rituximab can still achieve long-term survival if they're switched to tositumomab and Iodine-131 tositumomab (Bexxar Therapeutic Regimen)." In a study of "40 patients with indolent, follicular large-cell or transformed B-cell lymphoma," researchers found that "nine...achieved a complete response and 28 patients (72 percent) achieved some response." On average, the "duration of the response was 18.9 months," with "mean progression-free survival" at 10.4 months "for all 40 patients." Meanwhile, "median overall survival was 6.7 years after receiving tositumomab and Iodine-131 tositumomab."

New regimen may increase rate of remission in some patients with advanced follicular lymphoma.
Older patients with advanced follicular lymphoma achieved high rates of complete remission and two-year progression-free survival (PFS) with a brief course of chemoimmunotherapy, followed by consolidation with rituximab (Rituxan), according to findings reported at the American Society of Hematology annual meeting. Researchers found that of 242 patients with "stage 3-4 disease, bulky stage 2 disease, or stage 2 lymphoma with one or more adverse features," 55 achieved complete responses, while there were "partial responses in 37 percent" following "four cycles of chemoimmunotherapy." But, "after rituximab consolidation therapy, 69 percent of the patients had achieved complete responses, and 18 percent had partial responses."  
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