This excerpt taken from the TPTX 8-K filed Nov 14, 2007.
LA JOLLA, CA, November 14, 2007 TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced financial results for the third quarter ended September 30, 2007. For the three-month period, the Company posted revenue of $2.5 million and a net loss of $6.8 million. Cash and cash equivalents totaled $39.7 million at September 30, 2007.
Last quarter we continued to advance our three priority product candidates and most notably, after the quarter ended, we announced positive results from our Phase IIb clinical trial evaluating our lead compound, tezampanel, in acute migraine, said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. We now have two migraine studies in which tezampanel demonstrated statistically significant improvement on the primary end point of pain response at two hours post-dose compared to placebo. These Phase IIb results further establish the efficacy and safety of tezampanel and we are pleased to be advancing tezampanel into later-stage clinical development.
This excerpt taken from the TPTX 8-K filed Oct 22, 2007.
LA JOLLA, October 22, 2007 TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that tezampanel met the primary endpoint in a 306-patient, Phase IIb clinical trial for the treatment of a single, acute migraine attack. In the study, which evaluated tezampanel administered subcutaneously, the 40 mg dose demonstrated statistically significant improvement on headache pain response at two hours post-dose compared to placebo (78.2 percent versus 58.7 percent; p=0.033, corrected for multiplicity) and the response was sustained through 24 hours post-dose. Although not powered to demonstrate statistical significance, improvement in key secondary measures at 40 mg, nevertheless, were either statistically significant (p< 0.050) or trending (p< 0.100) when compared to placebo and corroborated the results for the primary endpoint of the study. These key secondary measures included nausea or vomiting, photophobia, a sum of pain intensity scores at three and four hours post-dose, sustained headache response at 24 hours, functional disability and a composite score of core migraine symptoms at two and four hours post-dose that included measures of headache severity, nausea, vomiting, photophobia, phonophobia and functional disability. The two other doses of tezampanel, 70 mg and 100 mg, were evaluated and also demonstrated effects across various pain measures although neither dose reached statistical significance on the primary endpoint. The company intends to submit the data from this trial to the U.S. Food and Drug Administration (FDA) in order to initiate a Phase III program in acute migraine in the second half of 2008.
In this trial, all three doses of tezampanel were well-tolerated. There were no serious or medically important adverse events reported. The most common adverse events associated with all doses of tezampanel, as well as placebo, were dry mouth, somnolence, dizziness, injection site burning and injection site pain. Injection site burning and injection site pain were more frequently reported in the placebo group. For tezampanel, the overall incidence of reported adverse events was dose related with the lowest incidence at the 40 mg dose.
These data demonstrate that tezampanel unequivocally relieved migraine pain at a dose that is safe and well-tolerated, said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines Therapeutics. I am proud that TorreyPines is in a position to potentially offer migraine patients the first novel treatment option in more than a decade. We look forward to meeting with the FDA to discuss advancing tezampanel into a Phase III trial in 2008.
This is the second placebo-controlled trial to establish efficacy for tezampanel as a treatment for acute migraine, said Michael Murphy, M.D., Ph.D., Chief Medical Officer of TorreyPines Therapeutics. Previously, in a Phase IIa, double-blind, placebo and active-controlled trial, tezampanel, administered intravenously, was more effective than placebo in relieving both migraine pain and associated symptoms. The clinical trial data are encouraging and allow us to appropriately design a Phase III program in migraine.
This excerpt taken from the TPTX 8-K filed Sep 25, 2007.
LA JOLLA, CA, September 25, 2007 TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced a one year extension of its research agreement with Eisai Co., Ltd. that was entered into on October 1, 2005. The extension marks the continuation of Eisais support of Alzheimers disease research at TorreyPines since 2001. This agreement, focusing on the discovery of Alzheimers disease targets using whole-genome family-based association screening, is one of two TorreyPines discovery collaborations with Eisai in the field of Alzheimers disease research. In a separate agreement, Eisai and TorreyPines are collaborating on the discovery of novel compounds to treat Alzheimers disease.
The goal of the genetics research collaboration is to identify and validate genes associated with Alzheimers disease as potential pharmaceutical targets. Under the terms of the agreement and in connection with the extension, TorreyPines will receive an upfront payment and continued research funding in support of the program for an additional year. In return, Eisai will continue to have exclusive rights of first negotiation and refusal for gene targets discovered and validated through the research.
We are pleased that Eisai, a leader in Alzheimers disease research, has elected to continue their long-standing support of our genetics discovery program, said Neil Kurtz, MD, President and Chief Executive Officer of TorreyPines Therapeutics. The extension of our collaboration with Eisai not only validates the importance of this research, but also moves us one step closer to our goal of discovering new therapies for patients suffering from Alzheimers disease.
The genetics research will be performed at TorreyPines in collaboration with Rudolph Tanzi, Ph.D., scientific co-founder of TorreyPines and Director of the Genetics and Aging Research Unit at the Massachusetts General Institute for Neurodegenerative Disorders (MIND).
The collaboration with Eisai has been very successful and one which I believe has the potential to yield valuable new genetic targets for drug discovery aimed at Alzheimers disease, said Dr. Tanzi.
This excerpt taken from the TPTX 8-K filed Aug 14, 2007.
LA JOLLA, CA, August 13, 2007 TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced financial results for the second quarter ended June 30, 2007. For the three-month period, the Company posted revenue of $2.5 million and a net loss of $5.2 million. Cash and cash equivalents totaled $46.7 million at June 30, 2007.
We continue to advance our product pipeline and anticipate announcing results from three clinical trials in the upcoming months. With full enrollment in our Phase IIb migraine trial for tezampanel, we are on track to report top-line results in the fourth quarter. In addition, by the end of the year we plan to announce results from the second Phase I trial of NGX426, the oral prodrug of tezampanel, and data from the multiple dose clinical trial of NGX267 for the potential treatment of cognitive impairment associated with schizophrenia, said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines.
This excerpt taken from the TPTX 8-K filed May 14, 2007.
LA JOLLA, CA, May 14, 2007 TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced financial results for the first quarter ended March 31, 2007. For the three-month period, the Company posted revenue of $2.5 million and a net loss of $3.3 million. Cash and cash equivalents totaled $52.5 million at March 31, 2007.
These results are in line with our expectations and reflect our continued progress in advancing our pipeline of novel small molecule product candidates in the clinic, said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. During this past quarter, we initiated additional clinical trials for both NGX426, an oral therapy in development for chronic pain, and NGX267, which is being evaluated for cognitive impairment associated with schizophrenia. We also extended our small molecule collaboration agreement with Eisai, furthering our long-standing relationship with one of the leading companies in Alzheimers disease research and treatment.
This excerpt taken from the TPTX 8-K filed Mar 29, 2007.
LA JOLLA, CA, March 29, 2007 TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced financial results for the year ended December 31, 2006. For the full year 2006, the Company posted revenue of $9.9 million and a net loss of $25.4 million. Cash and cash equivalents totaled $55.4 million at December 31, 2006.
Last year was an exciting period for TorreyPines. In October we initiated a Phase IIb clinical trial in acute migraine with tezampanel, our lead product candidate for chronic pain, and we became a public company. said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines Therapeutics. In 2006 we also filed an IND and completed a Phase I trial of NGX426, the oral prodrug of tezampanel; as well as completed a second Phase I trial with NGX267, our lead product candidate for the treatment of cognitive impairment associated with schizophrenia. For 2007, we have established aggressive corporate goals, including reporting clinical trial results for all three of these compounds while advancing our other promising product candidates.
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