TPTX » Topics » Clinical Development Overview-NGX426

This excerpt taken from the TPTX DEF 14A filed Jun 19, 2009.

Clinical Development Overview—NGX426

The results of our first Phase I single dose clinical trial of NGX426, given orally, demonstrated that NGX426 was well-tolerated and rapidly converted to tezampanel at 10 mg, 20 mg, and 30 mg. During 2008 we completed a Phase I clinical trial that was designed to identify the maximum tolerated single dose of NGX426 when given to healthy adults. Subjects were dosed up to 210 mg, the maximum dose allowable under the protocol. All doses were safe and well tolerated therefore the maximum tolerated dose was not reached. In December 2008 we announced that oral administration of a single dose of NGX426 to healthy male adults demonstrated a statistically significant reduction in spontaneous pain, hyperalgesia (abnormally increased pain state) and allodynia (pain resulting from normally non-painful stimuli to the skin) compared to placebo following injections under the skin of capsaicin in a human experimental model of induced pain, hyperalgesia and allodynia. Using a three-period cross-over design, subjects received two intradermal injections of capsaicin at 30 minutes and 120 minutes after administration of a single, oral dose of 90 mg or 150 mg of NGX426, or placebo. In February 2009 we announced that oral administration of NGX426 was safe and well-tolerated in healthy male and female subjects when dosed once daily for five consecutive days. We will need to secure additional funding in order to pursue the Phase II clinical development of NGX426.

These excerpts taken from the TPTX 10-K filed Mar 27, 2009.

Clinical Development Overview—NGX426

The results of our first Phase I single dose clinical trial of NGX426, given orally, demonstrated that NGX426 was well-tolerated and rapidly converted to tezampanel at 10 mg, 20 mg, and 30 mg. During 2008 we completed a Phase I clinical trial that was designed to identify the maximum tolerated single dose of NGX426 when given to healthy adults. Subjects were dosed up to 210 mg, the maximum dose allowable under the protocol. All doses were safe and well tolerated therefore the maximum tolerated dose was not reached. In December 2008 we announced that oral administration of a single dose of NGX426 to healthy male adults demonstrated a statistically significant reduction in spontaneous pain, hyperalgesia (abnormally increased pain state) and allodynia (pain resulting from normally non-painful stimuli to the skin) compared to placebo following injections under the skin of capsaicin in a human experimental model of induced pain, hyperalgesia and allodynia. Using a three-period cross-over design, subjects received two intradermal injections of capsaicin at 30 minutes and 120 minutes after administration of a single, oral dose of 90 mg or 150 mg of NGX426, or placebo. In February 2009 we announced that oral administration of NGX426 was safe and well-tolerated in healthy male and female subjects when dosed once daily for five consecutive days. We will need to secure additional funding in order to pursue the Phase II clinical development of NGX426.

Clinical Development
Overview—NGX426

The results of our first Phase I single dose clinical trial of NGX426, given orally, demonstrated that NGX426
was well-tolerated and rapidly converted to tezampanel at 10 mg, 20 mg, and 30 mg. During 2008 we completed a Phase I clinical trial that was designed to identify the maximum tolerated single dose of NGX426 when given to healthy adults. Subjects
were dosed up to 210 mg, the maximum dose allowable under the protocol. All doses were safe and well tolerated therefore the maximum tolerated dose was not reached. In December 2008 we announced that oral administration of a single dose of NGX426 to
healthy male adults demonstrated a statistically significant reduction in spontaneous pain, hyperalgesia (abnormally increased pain state) and allodynia (pain resulting from normally non-painful stimuli to the skin) compared to placebo following
injections under the skin of capsaicin in a human experimental model of induced pain, hyperalgesia and allodynia. Using a three-period cross-over design, subjects received two intradermal injections of capsaicin at 30 minutes and 120 minutes
after administration of a single, oral dose of 90 mg or 150 mg of NGX426, or placebo. In February 2009 we announced that oral administration of NGX426 was safe and well-tolerated in healthy male and female subjects when dosed once daily for five
consecutive days. We will need to secure additional funding in order to pursue the Phase II clinical development of NGX426.

These excerpts taken from the TPTX 10-K filed Mar 31, 2008.

Clinical Development Overview—NGX426

        The results of our first Phase I single dose clinical trial of NGX426, given orally, demonstrated that NGX426 was well-tolerated and rapidly converted to tezampanel at 10 mg, 20 mg, and 30 mg. In our on-going second Phase I clinical trial we intend to identify the maximum tolerated single dose of NGX426 when given to healthy adults. This clinical trial is designed as a randomized, double-blind, placebo-controlled study in which healthy adults will receive placebo or an escalating single dose of NGX426. We have completed dosing of subjects up to 150 mg and we will continue to dose until we reach either the maximum tolerated dose or up to a maximum of 210 mg. We expect to report results of this clinical trial in the second half of 2008.

        In the first half of 2008 we plan to evaluate the analgesic effect of NGX426 in healthy adults. The purpose of this trial is to show that tezampanel, when given orally as NGX426, maintains its analgesic activity. Additionally, in the second half of 2008 we intend to initiate a Phase I multiple dose trial of NGX426 in healthy adults.

Clinical Development Overview—NGX426



        The results of our first Phase I single dose clinical trial of NGX426, given orally, demonstrated that NGX426 was well-tolerated and rapidly
converted to tezampanel at 10 mg, 20 mg, and 30 mg. In our on-going second Phase I clinical trial we intend to identify the maximum tolerated single dose of NGX426 when given to
healthy adults. This clinical trial is designed as a randomized, double-blind, placebo-controlled study in which healthy adults will receive placebo or an escalating single dose of NGX426. We have
completed dosing of subjects up to 150 mg and we will continue to dose until we reach either the maximum tolerated dose or up to a maximum of 210 mg. We expect to report results of this clinical trial
in the second half of 2008.



        In
the first half of 2008 we plan to evaluate the analgesic effect of NGX426 in healthy adults. The purpose of this trial is to show that tezampanel, when given orally as NGX426,
maintains its analgesic activity. Additionally, in the second half of 2008 we intend to initiate a Phase I multiple dose trial of NGX426 in healthy adults.



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