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news.EpiCept, a US based developer of pharmaceutical products for the treatment of cancer and pain, has provided an update on AmiKet development program.
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Currently, the company has started designing a Phase III trial program and protocol to evaluate AmiKet in patients with chemotherapy-induced neuropathic pain (CIPN) to submit the new drug application (NDA) with the US Food and Drug Administration (FDA).
EpiCept president CEO Jack Talley said they are working towards a meeting with the US Food and Drug Administration (FDA) later this year, while the trial investigators who conducted the study are preparing a manuscript for publication in a peer-reviewed journal.
Further, the company has reported net loss of $4.34m for the second quarter ended 30 June 2011, compared to $4.88m for the same period in 2010.
The company’s loss from operations for the second quarter of 2011 was $4.07m, compared to $4.08m for the same period in 2010.
For the six months ended 30 June 2011, the company reported a net loss of $6.8m, compared to $9.39m for the same period in 2010.
EpiCept’s loss from operations was $7m for the six months of 2011, compared to $8.01m for the same period in 2010.