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Epix Pharmaceuticals
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics, and Bayer Schering Pharma AG, Germany.
Homepage: http://www.predixpharm.com/index.asp
Jahreschart:
Tageschart:
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen, Cystic Fibrosis Foundation Therapeutics, and Bayer Schering Pharma AG, Germany.
Homepage: http://www.predixpharm.com/index.asp
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Kommentar des NeuroInvestor von Anfang des Jahres
EPIX (NASDAQ: EPIX)
From NI January 2007
A most action-packed 2006 for Epix, which is basically Predix post-reverse-merger. When Predix's premature shot at an IPO capsized after just three months, they found a viable Plan B--merger with the imaging company Epix. They had the PR advantage of citing a Phase III compound, PRX-00023, a 5HT-1a agonist, in anxiety, a trial comprising only 310pts, after a 20pt PhII. That did fail (p=.11), but only after the merger had been consummated. They state that the drug will now be turned towards depression, based on a prespecified depression endpoint which hit p=.009. Their most advanced clinical program is with a 5-HT4 modulator, which is starting PhIIa in Alzheimer's, both with and without Aricept. PRX-3140 stimulates acetylcholine release, perhaps also activating MAPK pathways relevant to memory processes. That drug was a centerpiece of a late-year partnering coup, wherein GSK partnered with Epix on PRX-3140 and three other, undisclosed GPCR targets. Epix provides the targets and will use its GPCR skills to develop modulators for those targets. In return, they received $35 million upfront (half in an equity purchase), and what is cited as "$1.2 billion in potential milestones." Of course, the likelihood of hitting gold on all four targets is minuscule, but this was an impressive partnership, which raised Epix's profile considerably. It eclipsed an earlier partnership, where they received $20 million upfront from Amgen as part of a deal involving S1P1 modulators. Phase II also began for a COPD program. Epix does have a lot of cash on hand (over $100 million), and no shortage of chutzpah.
Quelle: http://www.neuroinvestment.com/Epix.html
EPIX (NASDAQ: EPIX)
From NI January 2007
A most action-packed 2006 for Epix, which is basically Predix post-reverse-merger. When Predix's premature shot at an IPO capsized after just three months, they found a viable Plan B--merger with the imaging company Epix. They had the PR advantage of citing a Phase III compound, PRX-00023, a 5HT-1a agonist, in anxiety, a trial comprising only 310pts, after a 20pt PhII. That did fail (p=.11), but only after the merger had been consummated. They state that the drug will now be turned towards depression, based on a prespecified depression endpoint which hit p=.009. Their most advanced clinical program is with a 5-HT4 modulator, which is starting PhIIa in Alzheimer's, both with and without Aricept. PRX-3140 stimulates acetylcholine release, perhaps also activating MAPK pathways relevant to memory processes. That drug was a centerpiece of a late-year partnering coup, wherein GSK partnered with Epix on PRX-3140 and three other, undisclosed GPCR targets. Epix provides the targets and will use its GPCR skills to develop modulators for those targets. In return, they received $35 million upfront (half in an equity purchase), and what is cited as "$1.2 billion in potential milestones." Of course, the likelihood of hitting gold on all four targets is minuscule, but this was an impressive partnership, which raised Epix's profile considerably. It eclipsed an earlier partnership, where they received $20 million upfront from Amgen as part of a deal involving S1P1 modulators. Phase II also began for a COPD program. Epix does have a lot of cash on hand (over $100 million), and no shortage of chutzpah.
Quelle: http://www.neuroinvestment.com/Epix.html
3 Abstrakte zum Neuroscience Meeting 2007
Preclinical and clinical antidepressant effects of the 5-ht1a receptor agonist PRX-00023
PRX-00023 [N-(3-(4-(4-(cyclohexylmethylsulfonamido)butyl)piperazin-1-yl)phenyl)acetamide] is a potent and highly selective partial agonist for the 5-HT1A receptor. Potential preclinical antidepressant effects of PRX-00023 were evaluated using the modified rat forced swim test (FST). PRX-00023 was active at 10 and 20 mg/kg (sc), causing reduced immobility, increased swimming but no change in climbing behavior. These antidepressant-like effects were not due to changes in locomotor activity. The pattern of response of PRX-00023 in the FST, reducing immobility and increasing swimming, was similar to that produced by fluoxetine. PRX-00023 was further evaluated in an 8-week, double-blind, placebo-controlled human clinical trial in patients with generalized anxiety disorder (GAD).
Male and female patients (aged 18-65 years), with a diagnosis of GAD were randomized to receive PRX-00023 (80 mg/day) or placebo. Since depression is often co-morbid with anxiety, depression, was evaluated with the Montgomery Asberg Depression Rating Scale (MADRS) as a secondary endpoint. For the primary endpoint, the Hamilton Anxiety Scale (HAM-A), the difference from placebo did not reach statistical significance at week 8 (p=0.1135) although a trend was apparent. By contrast, there was a significant drop in the MADRS score at the end of the study (p=0.0094) for patients receiving PRX-00023. Sexual function was assessed with the MGH sexual function scale and showed no impairment with PRX-00023 with a trend towards improvement that did not reach significance. There were no serious adverse events and the drug was well tolerated with headache as the most common adverse event (15.6% of patients vs. 10.9% of placebo). Based on these data, PRX-00023 is currently being evaluated in a trial involving patients with major depressive disorder. Results are anticipated in the second quarter of 2008.
PRX-07034, a 5-HT6 antagonist, reduces weight gain and enhances memory in a neurodevelopmental model of schizophrenia
Post-weaning social isolation in the rat induces a range of behavioral and neurochemical alterations similar to those observed in schizophrenia (Lapiz et al. 2003). The aim of this study was to evaluate PRX-07034, a novel and potent 5-HT6 antagonist (Ki 4nM) with demonstrated procognitive effects, in rats raised in social isolation. Thirty-eight male Lister hooded rats were raised in isolation from weaning (day 20-24) and 10 rats from the same litters were raised in social groups of 3-4.
From days 33-37 group-housed controls received vehicle intraperitoneal (ip) injections daily, and isolates received vehicle or PRX-07034 (1, 3, or 10mg/kg) ip injections daily. Locomotor activity was monitored on Day 36. On day 37 novel object discrimination (NOD) was assessed using a 2 hr inter-trial-interval with a 40-min pre-treatment (King et al. 2004). Prior to the start of injections (day 33), isolates tended to be heavier than social controls. This effect was normalized by PRX-07034. Cumulative weight gain across the treatment period was significantly lower in the 3 and 10mg/kg PRX-07034-treated groups compared to vehicle-treated social isolates (P<0.05 & P<0.001, respectively). Isolates exhibited increased levels of rearing and ambulation (P<0.001) which were returned to social control levels by PRX-07034 (3 & 10 mg/kg).
Social controls discriminated the novel from the familiar object (P<0.01), but isolates did not. PRX-07034 restored object discrimination in the isolates at all doses tested (1 & 3mg/kg P<0.01, 10mg/kg P<0.05). These results confirm that the procognitive effects of PRX-07034 previously observed in normal animals were maintained in rats exhibiting an isolation rearing-induced cognitive deficit. PRX-07034 also reversed the isolation-induced effects on activity and weight gain. Results support a potential role for PRX-07034 in the treatment of cognitive dysfunction associated with schizophrenia, as well as atypical antipsychotic-induced weight gain.
PRX-03140, a partial 5-HT4 agonist, potentiates the memory enhancing effect of an efficacious dose of donepezil on delayed spontaneous alternation
PRX-03140 is a 5-HT4 receptor partial agonist undergoing a Phase 2 clinical trial in an Alzheimer’s disease population. The clinical study includes a PRX-03140 monotherapy arm as well as PRX-03140 in combination with donepezil, an acetylcholinesterase inhibitor. Donepezil is one of the most commonly prescribed treatments to alleviate cognitive impairments in Alzheimer’s disease albeit with limited efficacy and dose-limiting side effects. Other treatments shown to enhance memory may provide additional benefits when given in combination with donepezil. Previous studies demonstrated that PRX-03140, a partial 5-HT4 receptor agonist, simultaneously enhances memory and potentiates hippocampal acetylcholine release during a spatial working memory test.
The present experiment investigated whether an efficacious, but suboptimal dose of donepezil would be enhanced by a low dose of PRX-03140. In a delayed spontaneous alternation paradigm, rats (n=6-9 per group) were administered either vehicle, PRX-03140 (0.03, 0.1 or 1.0 mg/kg, ip) or donepezil (0.3 mg/kg, ip) alone or a combination of PRX-03140 (0.1 mg/kg, ip) and donepezil (0.3 mg/kg, ip) 30 minutes prior to delayed spontaneous alternation testing. Testing was carried out in a 4-arm cross maze. A test session lasted 15 minutes and a 30 second delay was inserted between each arm choice. Results indicated that PRX-03140 at 0.03 or 0.1 mg/kg did not affect delayed spontaneous alternation performance. PRX-03140 at 1 mg/kg produced significant enhancement (p<0.01 vs vehicle-treated).
Donepezil (0.3 mg/kg) had a modest significant effect on delayed spontaneous alternation performance. In contrast, the combination of PRX-03140 (0.1 mg/kg) and donepezil (0.3 mg/kg) produced a significant enhancement of delayed spontaneous alternation performance that was much greater than donepezil alone (p<0.01). The findings suggest that a low dose of PRX-03140 may further enhance the effects of donepezil resulting in a greater improvement in cognitive function than that produced by donepezil alone.
Preclinical and clinical antidepressant effects of the 5-ht1a receptor agonist PRX-00023
PRX-00023 [N-(3-(4-(4-(cyclohexylmethylsulfonamido)butyl)piperazin-1-yl)phenyl)acetamide] is a potent and highly selective partial agonist for the 5-HT1A receptor. Potential preclinical antidepressant effects of PRX-00023 were evaluated using the modified rat forced swim test (FST). PRX-00023 was active at 10 and 20 mg/kg (sc), causing reduced immobility, increased swimming but no change in climbing behavior. These antidepressant-like effects were not due to changes in locomotor activity. The pattern of response of PRX-00023 in the FST, reducing immobility and increasing swimming, was similar to that produced by fluoxetine. PRX-00023 was further evaluated in an 8-week, double-blind, placebo-controlled human clinical trial in patients with generalized anxiety disorder (GAD).
Male and female patients (aged 18-65 years), with a diagnosis of GAD were randomized to receive PRX-00023 (80 mg/day) or placebo. Since depression is often co-morbid with anxiety, depression, was evaluated with the Montgomery Asberg Depression Rating Scale (MADRS) as a secondary endpoint. For the primary endpoint, the Hamilton Anxiety Scale (HAM-A), the difference from placebo did not reach statistical significance at week 8 (p=0.1135) although a trend was apparent. By contrast, there was a significant drop in the MADRS score at the end of the study (p=0.0094) for patients receiving PRX-00023. Sexual function was assessed with the MGH sexual function scale and showed no impairment with PRX-00023 with a trend towards improvement that did not reach significance. There were no serious adverse events and the drug was well tolerated with headache as the most common adverse event (15.6% of patients vs. 10.9% of placebo). Based on these data, PRX-00023 is currently being evaluated in a trial involving patients with major depressive disorder. Results are anticipated in the second quarter of 2008.
PRX-07034, a 5-HT6 antagonist, reduces weight gain and enhances memory in a neurodevelopmental model of schizophrenia
Post-weaning social isolation in the rat induces a range of behavioral and neurochemical alterations similar to those observed in schizophrenia (Lapiz et al. 2003). The aim of this study was to evaluate PRX-07034, a novel and potent 5-HT6 antagonist (Ki 4nM) with demonstrated procognitive effects, in rats raised in social isolation. Thirty-eight male Lister hooded rats were raised in isolation from weaning (day 20-24) and 10 rats from the same litters were raised in social groups of 3-4.
From days 33-37 group-housed controls received vehicle intraperitoneal (ip) injections daily, and isolates received vehicle or PRX-07034 (1, 3, or 10mg/kg) ip injections daily. Locomotor activity was monitored on Day 36. On day 37 novel object discrimination (NOD) was assessed using a 2 hr inter-trial-interval with a 40-min pre-treatment (King et al. 2004). Prior to the start of injections (day 33), isolates tended to be heavier than social controls. This effect was normalized by PRX-07034. Cumulative weight gain across the treatment period was significantly lower in the 3 and 10mg/kg PRX-07034-treated groups compared to vehicle-treated social isolates (P<0.05 & P<0.001, respectively). Isolates exhibited increased levels of rearing and ambulation (P<0.001) which were returned to social control levels by PRX-07034 (3 & 10 mg/kg).
Social controls discriminated the novel from the familiar object (P<0.01), but isolates did not. PRX-07034 restored object discrimination in the isolates at all doses tested (1 & 3mg/kg P<0.01, 10mg/kg P<0.05). These results confirm that the procognitive effects of PRX-07034 previously observed in normal animals were maintained in rats exhibiting an isolation rearing-induced cognitive deficit. PRX-07034 also reversed the isolation-induced effects on activity and weight gain. Results support a potential role for PRX-07034 in the treatment of cognitive dysfunction associated with schizophrenia, as well as atypical antipsychotic-induced weight gain.
PRX-03140, a partial 5-HT4 agonist, potentiates the memory enhancing effect of an efficacious dose of donepezil on delayed spontaneous alternation
PRX-03140 is a 5-HT4 receptor partial agonist undergoing a Phase 2 clinical trial in an Alzheimer’s disease population. The clinical study includes a PRX-03140 monotherapy arm as well as PRX-03140 in combination with donepezil, an acetylcholinesterase inhibitor. Donepezil is one of the most commonly prescribed treatments to alleviate cognitive impairments in Alzheimer’s disease albeit with limited efficacy and dose-limiting side effects. Other treatments shown to enhance memory may provide additional benefits when given in combination with donepezil. Previous studies demonstrated that PRX-03140, a partial 5-HT4 receptor agonist, simultaneously enhances memory and potentiates hippocampal acetylcholine release during a spatial working memory test.
The present experiment investigated whether an efficacious, but suboptimal dose of donepezil would be enhanced by a low dose of PRX-03140. In a delayed spontaneous alternation paradigm, rats (n=6-9 per group) were administered either vehicle, PRX-03140 (0.03, 0.1 or 1.0 mg/kg, ip) or donepezil (0.3 mg/kg, ip) alone or a combination of PRX-03140 (0.1 mg/kg, ip) and donepezil (0.3 mg/kg, ip) 30 minutes prior to delayed spontaneous alternation testing. Testing was carried out in a 4-arm cross maze. A test session lasted 15 minutes and a 30 second delay was inserted between each arm choice. Results indicated that PRX-03140 at 0.03 or 0.1 mg/kg did not affect delayed spontaneous alternation performance. PRX-03140 at 1 mg/kg produced significant enhancement (p<0.01 vs vehicle-treated).
Donepezil (0.3 mg/kg) had a modest significant effect on delayed spontaneous alternation performance. In contrast, the combination of PRX-03140 (0.1 mg/kg) and donepezil (0.3 mg/kg) produced a significant enhancement of delayed spontaneous alternation performance that was much greater than donepezil alone (p<0.01). The findings suggest that a low dose of PRX-03140 may further enhance the effects of donepezil resulting in a greater improvement in cognitive function than that produced by donepezil alone.
Epix Factsheet 29. September 2007
Epix strebt mit Vasovist eine Zulassung in den USA an. Zur Zeit besteht noch Diskussionsbedarf. Eine weitere Studie soll aber nicht nötig sein. Einige Ausführungen zu Vasovist von dem Partner Bayer - Schering.
Vasovist® eröffnet neue Optionen in der Radiologie
Die Magnetresonanz-Angiographie (MRA) gewinnt bei der Diagnostik von Gefäßerkrankungen des Bauchraums zunehmend an Bedeutung, führte Professor Tim Leiner, Maastricht, aus. Weil das Bloodpool-Kontrastmittel Vasovist® an Albumin bindet, hat es eine viel höhere Relaxivität (Kontrastverstärkung) und einen längere Verweildauer in den Gefäßen als konventionelle extrazelluläre Kontrastmittel. Die größere Relaxivität ermöglicht eine höhere Auflösung bei der First-pass-Bildgebung ohne einen substanziellen Verlust des Kontrastes von Gefäßen zum Hintergrund. Durch die längere intravaskuläre Verweildauer ist die Möglichkeit gegeben, auch andere arterielle Gebiete einzusehen, betonte Leiner.
Mit Vasovist® eröffnen sich neue Optionen für die Radiologen, sagte Dr. Joachim Lotz, Hannover. Bisher war die Bildgebung der venösen Gefäße wegen der inhomogenen Kontrastmittel-Verteilung eine Herausforderung. Bloodpool-Kontrastmittel haben das Potenzial, dies zu überwinden. Denn sie bieten einen homogenen Kontrast in den Arterien und den Venen in der Gleichgewichtsphase der Kontrastmittelverteilung. Lotz sieht die Hauptindikationen bei der Diagnostik von tiefen Venenthrombosen im Unter- und Oberschenkel und bei der Bildgebung von Hämodialyse-Shunts in den Armen. Wie Lotz weiter sagte, ist nach seinen Erfahrungen die venöse Bildgebung mit dem Bloodpool-Kontrsatmittel verlässlich, einfach anzuwenden und von konstanter hoher Qualität.
Die Einführung von Vasovist® erweitert das Potenzial der MRT bei der Diagnose einer Lungenembolie und der tiefen Venenthrombose, erklärte Dr. Christian Fink, München. Nach einer einzigen Bolus-Injektion von Vasovist® können die Lungen mit der MRA dynamisch zur Bewertung der Lungenperfusion dargestellt werden. Letztendlich kann eine MR-Venographie des ganzen Körpers vorgenommen werden, um eine zugrunde liegende tiefe Venenthrombose zu erkennen. Wie Fink weiter ausführte, kann bei Verdacht auf Lungenembolie und tiefe Venenthrombose dann eine MRA als erstes diagnostisches Verfahren erwogen werden, wenn klinisch eine geringe Wahrscheinlichkeit für diese Erkrankungen besteht, wenn Kontraindikationen gegen jodierte Kontrastmittel relevant sind, außerdem bei jungen Frauen.
Das Bloodpool-Kontrastmittel hat sich als sehr effektiv bei der MRA der Karotiden und der intrazerebralen Zirkulation erwiesen, sagte Professor Marco Essig, Heidelberg. Eine einzige Dosis reicht aus, um eine qualitativ hochwertige Bildgebung in der First-pass-Situation und eine hohe Auflösung im Steady State zu erreichen. Vasovist® bietet Essig zufolge ein großes Potenzial für verschiedene Indikationen wie zerebrovaskuläre Erkrankungen und Gefäßveränderungen im Gehirn.
Vasovist® hat auch das Potenzial, die periphere MRA zu verbessern, betonte Dr. Winfried Willinek, Bonn. Wegen der hohen Relaxivität und dem erweiterten Bildfenster bietet sich die Möglichkeit, nicht nur die First-pass-MRA der Unterschenkelgefäße zu verbessern, sondern auch eine ultra-hohe räumliche Auflösung im Steady State zu erreichen. Dadurch lassen sich mehr Gefäßsegmente als mit der Standard-Technik allein darstellen. Dies kann die Therapie derjenigen Patienten verbessern, bei denen mehr distale Gefäße identifiziert werden müssen, die für eine Bypass-Operation infrage kommen.
Vasovist® eröffnet neue Optionen in der Radiologie
Die Magnetresonanz-Angiographie (MRA) gewinnt bei der Diagnostik von Gefäßerkrankungen des Bauchraums zunehmend an Bedeutung, führte Professor Tim Leiner, Maastricht, aus. Weil das Bloodpool-Kontrastmittel Vasovist® an Albumin bindet, hat es eine viel höhere Relaxivität (Kontrastverstärkung) und einen längere Verweildauer in den Gefäßen als konventionelle extrazelluläre Kontrastmittel. Die größere Relaxivität ermöglicht eine höhere Auflösung bei der First-pass-Bildgebung ohne einen substanziellen Verlust des Kontrastes von Gefäßen zum Hintergrund. Durch die längere intravaskuläre Verweildauer ist die Möglichkeit gegeben, auch andere arterielle Gebiete einzusehen, betonte Leiner.
Mit Vasovist® eröffnen sich neue Optionen für die Radiologen, sagte Dr. Joachim Lotz, Hannover. Bisher war die Bildgebung der venösen Gefäße wegen der inhomogenen Kontrastmittel-Verteilung eine Herausforderung. Bloodpool-Kontrastmittel haben das Potenzial, dies zu überwinden. Denn sie bieten einen homogenen Kontrast in den Arterien und den Venen in der Gleichgewichtsphase der Kontrastmittelverteilung. Lotz sieht die Hauptindikationen bei der Diagnostik von tiefen Venenthrombosen im Unter- und Oberschenkel und bei der Bildgebung von Hämodialyse-Shunts in den Armen. Wie Lotz weiter sagte, ist nach seinen Erfahrungen die venöse Bildgebung mit dem Bloodpool-Kontrsatmittel verlässlich, einfach anzuwenden und von konstanter hoher Qualität.
Die Einführung von Vasovist® erweitert das Potenzial der MRT bei der Diagnose einer Lungenembolie und der tiefen Venenthrombose, erklärte Dr. Christian Fink, München. Nach einer einzigen Bolus-Injektion von Vasovist® können die Lungen mit der MRA dynamisch zur Bewertung der Lungenperfusion dargestellt werden. Letztendlich kann eine MR-Venographie des ganzen Körpers vorgenommen werden, um eine zugrunde liegende tiefe Venenthrombose zu erkennen. Wie Fink weiter ausführte, kann bei Verdacht auf Lungenembolie und tiefe Venenthrombose dann eine MRA als erstes diagnostisches Verfahren erwogen werden, wenn klinisch eine geringe Wahrscheinlichkeit für diese Erkrankungen besteht, wenn Kontraindikationen gegen jodierte Kontrastmittel relevant sind, außerdem bei jungen Frauen.
Das Bloodpool-Kontrastmittel hat sich als sehr effektiv bei der MRA der Karotiden und der intrazerebralen Zirkulation erwiesen, sagte Professor Marco Essig, Heidelberg. Eine einzige Dosis reicht aus, um eine qualitativ hochwertige Bildgebung in der First-pass-Situation und eine hohe Auflösung im Steady State zu erreichen. Vasovist® bietet Essig zufolge ein großes Potenzial für verschiedene Indikationen wie zerebrovaskuläre Erkrankungen und Gefäßveränderungen im Gehirn.
Vasovist® hat auch das Potenzial, die periphere MRA zu verbessern, betonte Dr. Winfried Willinek, Bonn. Wegen der hohen Relaxivität und dem erweiterten Bildfenster bietet sich die Möglichkeit, nicht nur die First-pass-MRA der Unterschenkelgefäße zu verbessern, sondern auch eine ultra-hohe räumliche Auflösung im Steady State zu erreichen. Dadurch lassen sich mehr Gefäßsegmente als mit der Standard-Technik allein darstellen. Dies kann die Therapie derjenigen Patienten verbessern, bei denen mehr distale Gefäße identifiziert werden müssen, die für eine Bypass-Operation infrage kommen.
Trading Spotlight
Neue Termine von der Konferenz gestern. Deswegen eine aktuallisierte Ausgabe des Schaubildes.
Antwort auf Beitrag Nr.: 31.851.098 von Erbse1 am 05.10.07 09:35:44Molecular Coronary MR Imaging of Human Thrombi using EP-2104R, a Fibrin-Targeted Contrast Agent:
Experimental Study in a Swine Model.Spuentrup E, Katoh M, Wiethoff AJ, Buecker A, Botnar RM, Parsons EC, Guenther RW.
Department of Diagnostic Radiology, Aachen Technical University, Aachen, Germany.
PURPOSE: The aim of this study was to investigate the use of a fibrin-specific contrast agent (EP-2104R, EPIX Pharmaceuticals, Lexington, Massachusetts, USA) for targeted molecular magnetic resonance (MR) imaging of human clot material removed from patients in a model of coronary thrombosis in swine. MATERIALS AND METHODS: Freshly ex vivo engineered clots from human blood and human in situ developed clots removed from patients were delivered into the coronary arteries of nine domestic swine. For MR imaging a navigator-gated, free-breathing, cardiac-triggered 3D inversion recovery black-blood gradient echo sequence was performed prior to clot delivery (baseline), after clot delivery but prior to contrast media administration, and two hours after systemic (i. v.) injection of 4 micromol/kg EP-2104R.
MR images were analyzed by two investigators and the contrast-to-noise ratio and Gadolinium (Gd) concentration in the clots were assessed. RESULTS: On baseline images and prior to contrast media application no thrombi were visible. Post contrast administration all 10 coronary emboli (five ex vivo engineered clots and five human clots removed from patients) were selectively visualized as white spots with a mean contrast-to-noise ratio to the blood pool and the surrounding tissue of > 12 and a mean Gd concentration of > 100 microM. CONCLUSION: Molecular MR imaging using the fibrin-targeted contrast agent EP-2104R allows selective visualization of human clot material in a model of coronary thrombosis in swine.
PMID: 17948194 [PubMed - in process]
Experimental Study in a Swine Model.Spuentrup E, Katoh M, Wiethoff AJ, Buecker A, Botnar RM, Parsons EC, Guenther RW.
Department of Diagnostic Radiology, Aachen Technical University, Aachen, Germany.
PURPOSE: The aim of this study was to investigate the use of a fibrin-specific contrast agent (EP-2104R, EPIX Pharmaceuticals, Lexington, Massachusetts, USA) for targeted molecular magnetic resonance (MR) imaging of human clot material removed from patients in a model of coronary thrombosis in swine. MATERIALS AND METHODS: Freshly ex vivo engineered clots from human blood and human in situ developed clots removed from patients were delivered into the coronary arteries of nine domestic swine. For MR imaging a navigator-gated, free-breathing, cardiac-triggered 3D inversion recovery black-blood gradient echo sequence was performed prior to clot delivery (baseline), after clot delivery but prior to contrast media administration, and two hours after systemic (i. v.) injection of 4 micromol/kg EP-2104R.
MR images were analyzed by two investigators and the contrast-to-noise ratio and Gadolinium (Gd) concentration in the clots were assessed. RESULTS: On baseline images and prior to contrast media application no thrombi were visible. Post contrast administration all 10 coronary emboli (five ex vivo engineered clots and five human clots removed from patients) were selectively visualized as white spots with a mean contrast-to-noise ratio to the blood pool and the surrounding tissue of > 12 and a mean Gd concentration of > 100 microM. CONCLUSION: Molecular MR imaging using the fibrin-targeted contrast agent EP-2104R allows selective visualization of human clot material in a model of coronary thrombosis in swine.
PMID: 17948194 [PubMed - in process]
Antwort auf Beitrag Nr.: 32.095.735 von Erbse1 am 21.10.07 07:36:18EP-2104R
Blood clots are a major underlying cause of the morbidity and mortality of several diseases, including stroke, heart attacks, deep vein thrombosis, pulmonary embolism, and atrial fibrillation. Blood clots are responsible for approximately 80% of the 700,000 strokes that occur annually in the United States. A minimally-invasive method of detecting clots would fulfill an enormous unmet clinical need.
EP-2104R is an imaging pharmaceutical under development, designed to meet that need, enabling detection of blood clots using MRI. It is the first targeted high-resolution technique designed to visualize blood clots directly. EPIX Pharmaceuticals researchers developed it by creating a new molecular complex that binds specifically to fibrin, a protein present in all blood clots. The process involved five years of research and the screening of millions of targeted molecules. Clinical trials of EP-2104R began in summer 2004.
Pre-clinical studies have shown promise for using MRI with EP-2104R for the early detection of blood clots in arteries and veins throughout the body. EP-2104R could prove to be an effective tool in risk assessment and evaluation of therapeutic options.
CHICAGO and LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 29, 2006--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) announced today the results from a Phase 2a clinical trial of EP-2104R, a novel fibrin-binding thrombus (clot) imaging agent, as presented during an oral presentation at the Radiological Society of North America (RSNA) Annual Meeting in Chicago, Illinois. The results of the Phase 2a trial found that EP-2104R was able to detect blood clots not previously seen on magnetic resonance imaging (MRI) and enhanced the images of clots previously seen on MRI. Blood clots are a major underlying cause of several diseases including deep vein thrombosis, pulmonary embolism, heart attack and stroke, and identifying a minimally invasive method for detecting clots would address a substantial medical need.
"We are very pleased with the results from this study," said Andrew Uprichard, M.D., president of EPIX Pharmaceuticals. "This trial evaluated EP-2104R as a potential contrast agent for use in MRI to detect thrombi. The data show EP-2104R was well-tolerated and able to detect or enhance clots on MRI images in all six of the body systems studied. In many cases existing modalities are not able to provide a definitive thrombus diagnosis and multiple tests must be conducted to reach a definitive diagnosis. EP-2104R could potentially replace multiple tests resulting in significant cost savings. With these encouraging data, we intend to seek a collaboration to continue to develop EP-2104R."
The Phase 2a trial was an open-label study designed to examine the imaging qualities of EP-2104R in a clinical setting. The trial included two studies with a total of 52 patients. The first study involved 14 patients in two cohorts: six patients in a pulmonary embolism cohort and eight patients in a deep vein thrombosis cohort. The second included 38 patients in four cohorts: 15 patients in a carotid artery cohort; eight patients in an atrial thrombus cohort; nine patients in a left ventricle cohort; and six patients in a thoracic aorta cohort.
All patients underwent an initial reference exam to establish a diagnosis of the presence of thrombus, or a strong likelihood of the presence of thrombus. Study participants were given a 4 micromol/kg bolus dose of EP-2104R and contrast imaging was performed within minutes. A second round of imaging was performed two to five hours following administration of EP-2104R and some of the study participants underwent a third imaging session 24 hours after receiving EP-2104R. Clots were visualized from two to 24 hours following administration of EP-2104R.
"The results from this study demonstrate that EP-2104R is effective in detecting clots not readily visible in pre-contrast screening and can show additional enhancement in those clots previously seen through non-contrast imaging," said Josef Vymazal, M.D., Ph.D., Hospital Na Holmolce, Czech Republic and study investigator. "In addition, EP-2104R detected previously unseen pathologies in some patients in the trial and the results show that we may be able to utilize EP-2104R in contrast enhanced vascular imaging."
About EP-2104R
EP-2104R is a novel fibrin-imaging agent used to identify blood clots using MRI. EP-2104R is the first targeted high-resolution technique designed to visualize blood clots directly. EPIX Pharmaceuticals researchers developed it by creating a new molecular complex that binds specifically to fibrin, a protein present in all blood clots. Pre-clinical studies have shown promise for using MRI with EP-2104R for the early detection of blood clots in arteries and veins throughout the body. EP-2104R could be an effective tool in risk assessment and evaluation of therapeutic options.
Blood clots are a major underlying cause of the morbidity and mortality of several diseases, including stroke, heart attacks, deep vein thrombosis, pulmonary embolism, and atrial fibrillation. Blood clots are responsible for approximately 80 percent of the 700,000 strokes that occur annually in the United States. A minimally-invasive method of detecting clots would fulfill a significant unmet need.
Blood clots are a major underlying cause of the morbidity and mortality of several diseases, including stroke, heart attacks, deep vein thrombosis, pulmonary embolism, and atrial fibrillation. Blood clots are responsible for approximately 80% of the 700,000 strokes that occur annually in the United States. A minimally-invasive method of detecting clots would fulfill an enormous unmet clinical need.
EP-2104R is an imaging pharmaceutical under development, designed to meet that need, enabling detection of blood clots using MRI. It is the first targeted high-resolution technique designed to visualize blood clots directly. EPIX Pharmaceuticals researchers developed it by creating a new molecular complex that binds specifically to fibrin, a protein present in all blood clots. The process involved five years of research and the screening of millions of targeted molecules. Clinical trials of EP-2104R began in summer 2004.
Pre-clinical studies have shown promise for using MRI with EP-2104R for the early detection of blood clots in arteries and veins throughout the body. EP-2104R could prove to be an effective tool in risk assessment and evaluation of therapeutic options.
CHICAGO and LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 29, 2006--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) announced today the results from a Phase 2a clinical trial of EP-2104R, a novel fibrin-binding thrombus (clot) imaging agent, as presented during an oral presentation at the Radiological Society of North America (RSNA) Annual Meeting in Chicago, Illinois. The results of the Phase 2a trial found that EP-2104R was able to detect blood clots not previously seen on magnetic resonance imaging (MRI) and enhanced the images of clots previously seen on MRI. Blood clots are a major underlying cause of several diseases including deep vein thrombosis, pulmonary embolism, heart attack and stroke, and identifying a minimally invasive method for detecting clots would address a substantial medical need.
"We are very pleased with the results from this study," said Andrew Uprichard, M.D., president of EPIX Pharmaceuticals. "This trial evaluated EP-2104R as a potential contrast agent for use in MRI to detect thrombi. The data show EP-2104R was well-tolerated and able to detect or enhance clots on MRI images in all six of the body systems studied. In many cases existing modalities are not able to provide a definitive thrombus diagnosis and multiple tests must be conducted to reach a definitive diagnosis. EP-2104R could potentially replace multiple tests resulting in significant cost savings. With these encouraging data, we intend to seek a collaboration to continue to develop EP-2104R."
The Phase 2a trial was an open-label study designed to examine the imaging qualities of EP-2104R in a clinical setting. The trial included two studies with a total of 52 patients. The first study involved 14 patients in two cohorts: six patients in a pulmonary embolism cohort and eight patients in a deep vein thrombosis cohort. The second included 38 patients in four cohorts: 15 patients in a carotid artery cohort; eight patients in an atrial thrombus cohort; nine patients in a left ventricle cohort; and six patients in a thoracic aorta cohort.
All patients underwent an initial reference exam to establish a diagnosis of the presence of thrombus, or a strong likelihood of the presence of thrombus. Study participants were given a 4 micromol/kg bolus dose of EP-2104R and contrast imaging was performed within minutes. A second round of imaging was performed two to five hours following administration of EP-2104R and some of the study participants underwent a third imaging session 24 hours after receiving EP-2104R. Clots were visualized from two to 24 hours following administration of EP-2104R.
"The results from this study demonstrate that EP-2104R is effective in detecting clots not readily visible in pre-contrast screening and can show additional enhancement in those clots previously seen through non-contrast imaging," said Josef Vymazal, M.D., Ph.D., Hospital Na Holmolce, Czech Republic and study investigator. "In addition, EP-2104R detected previously unseen pathologies in some patients in the trial and the results show that we may be able to utilize EP-2104R in contrast enhanced vascular imaging."
About EP-2104R
EP-2104R is a novel fibrin-imaging agent used to identify blood clots using MRI. EP-2104R is the first targeted high-resolution technique designed to visualize blood clots directly. EPIX Pharmaceuticals researchers developed it by creating a new molecular complex that binds specifically to fibrin, a protein present in all blood clots. Pre-clinical studies have shown promise for using MRI with EP-2104R for the early detection of blood clots in arteries and veins throughout the body. EP-2104R could be an effective tool in risk assessment and evaluation of therapeutic options.
Blood clots are a major underlying cause of the morbidity and mortality of several diseases, including stroke, heart attacks, deep vein thrombosis, pulmonary embolism, and atrial fibrillation. Blood clots are responsible for approximately 80 percent of the 700,000 strokes that occur annually in the United States. A minimally-invasive method of detecting clots would fulfill a significant unmet need.
EPIX Pharmaceuticals Completes Enrollment in Two Key Clinical Trials
Rapid Enrollment of Phase 2b Depression Trial Moves-up Timeline -
Data Now Expected in 1Q08
Data from Phase 2a Alzheimer's Trial 0n Track for 4Q07
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 25, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it has met its enrollment target of 330 patients in U.S. centers for its Phase 2b trial of PRX-00023 in Major Depressive Disorder (MDD). As a result of this rapid enrollment, EPIX expects to announce results of this trial in the first quarter of 2008. Further, EPIX has completed enrollment of its Phase 2a clinical trial of PRX-03140 in Alzheimer's disease and reaffirmed that it is on track to announce the findings of this study by the end of 2007.
"We are very pleased to achieve these significant milestones for these two important clinical trials," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "We believe that the rapid pace at which we were able to recruit patients into the Phase 2b MDD trial is indicative of the interest in, and need for, new and improved treatments for depression."
PRX-00023 Phase 2b in Major Depressive Disorder
PRX-00023 is a novel, highly selective 5-HT1A partial agonist discovered using the company's proprietary G-Protein Coupled Receptors (GPCR) modeling, screening and lead optimization technology. PRX-00023 is targeting a significant unmet medical need for a selective 5-HT1A agonist used in the treatment of depression that avoids the sexual dysfunction, withdrawal symptoms and sleep disturbances typically associated with selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs), lacks the addictive and sedative effects of the benzodiazepines, and does not have the slow onset, short half-life, and side effects of a chemical class of 5-HT1A agonists called azapirones. EPIX has secured composition of matter patent protection for PRX-00023 through 2024.
In the first randomized trial of PRX-00023 conducted last year, 80 mg once daily of PRX-00023 showed significant improvement (p=0.009) in the pre-specified endpoint of MADRS in patients with generalized anxiety disorder. The current randomized, double-blind, placebo-controlled Phase 2b trial is designed to evaluate the effect of treatment with up to 120 mg of PRX-00023 twice-daily for eight weeks as determined by change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) compared with placebo. Patients in the current trial randomized to the drug treatment will begin with 40 mg PRX-00023 twice daily, and increase the dose, if tolerated, to a maximum of 120 mg twice daily within the first week. The trial has met its enrollment target of 330 adult patients with MDD. Changes in the Hamilton Anxiety Score (HAM-A), Clinical Global Impressions Improvement Scale (CGI-I) and Clinical Global Severity of Illness Scale (CGI-S) will be measured as secondary endpoints. PRX-00023 has been studied in more than 250 subjects to date and previous clinical trials have shown the drug to be well tolerated up to 320 mg per day with a low incidence of sexual dysfunction and sleep disorders.
PRX-03140 in Alzheimer's Disease
PRX-03140 is EPIX's second of four clinical drug candidates discovered utilizing its proprietary computer-based G-Protein Coupled Receptors (GPCR) models and optimized with integrated computational-medicinal chemistry. PRX-03140 is selective for the 5-HT4 receptor in the brain, and preclinical studies have shown that it may improve cognitive function and increase levels of acetylcholine, soluble amyloid precursor protein (sAPP) and brain-derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory. GlaxoSmithKline has an exclusive option to license PRX-03140 for further development and commercialization on a worldwide basis once EPIX has achieved clinical proof of concept.
This Phase 2a clinical trial is designed to further evaluate PRX-03140 as monotherapy and in combination with donepezil (Aricept(R)) for the treatment of Alzheimer's disease. The current Phase 2a trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRX-03140 administered orally once-daily stable dose of 10mg donepezil.
Rapid Enrollment of Phase 2b Depression Trial Moves-up Timeline -
Data Now Expected in 1Q08
Data from Phase 2a Alzheimer's Trial 0n Track for 4Q07
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 25, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it has met its enrollment target of 330 patients in U.S. centers for its Phase 2b trial of PRX-00023 in Major Depressive Disorder (MDD). As a result of this rapid enrollment, EPIX expects to announce results of this trial in the first quarter of 2008. Further, EPIX has completed enrollment of its Phase 2a clinical trial of PRX-03140 in Alzheimer's disease and reaffirmed that it is on track to announce the findings of this study by the end of 2007.
"We are very pleased to achieve these significant milestones for these two important clinical trials," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "We believe that the rapid pace at which we were able to recruit patients into the Phase 2b MDD trial is indicative of the interest in, and need for, new and improved treatments for depression."
PRX-00023 Phase 2b in Major Depressive Disorder
PRX-00023 is a novel, highly selective 5-HT1A partial agonist discovered using the company's proprietary G-Protein Coupled Receptors (GPCR) modeling, screening and lead optimization technology. PRX-00023 is targeting a significant unmet medical need for a selective 5-HT1A agonist used in the treatment of depression that avoids the sexual dysfunction, withdrawal symptoms and sleep disturbances typically associated with selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs), lacks the addictive and sedative effects of the benzodiazepines, and does not have the slow onset, short half-life, and side effects of a chemical class of 5-HT1A agonists called azapirones. EPIX has secured composition of matter patent protection for PRX-00023 through 2024.
In the first randomized trial of PRX-00023 conducted last year, 80 mg once daily of PRX-00023 showed significant improvement (p=0.009) in the pre-specified endpoint of MADRS in patients with generalized anxiety disorder. The current randomized, double-blind, placebo-controlled Phase 2b trial is designed to evaluate the effect of treatment with up to 120 mg of PRX-00023 twice-daily for eight weeks as determined by change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) compared with placebo. Patients in the current trial randomized to the drug treatment will begin with 40 mg PRX-00023 twice daily, and increase the dose, if tolerated, to a maximum of 120 mg twice daily within the first week. The trial has met its enrollment target of 330 adult patients with MDD. Changes in the Hamilton Anxiety Score (HAM-A), Clinical Global Impressions Improvement Scale (CGI-I) and Clinical Global Severity of Illness Scale (CGI-S) will be measured as secondary endpoints. PRX-00023 has been studied in more than 250 subjects to date and previous clinical trials have shown the drug to be well tolerated up to 320 mg per day with a low incidence of sexual dysfunction and sleep disorders.
PRX-03140 in Alzheimer's Disease
PRX-03140 is EPIX's second of four clinical drug candidates discovered utilizing its proprietary computer-based G-Protein Coupled Receptors (GPCR) models and optimized with integrated computational-medicinal chemistry. PRX-03140 is selective for the 5-HT4 receptor in the brain, and preclinical studies have shown that it may improve cognitive function and increase levels of acetylcholine, soluble amyloid precursor protein (sAPP) and brain-derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory. GlaxoSmithKline has an exclusive option to license PRX-03140 for further development and commercialization on a worldwide basis once EPIX has achieved clinical proof of concept.
This Phase 2a clinical trial is designed to further evaluate PRX-03140 as monotherapy and in combination with donepezil (Aricept(R)) for the treatment of Alzheimer's disease. The current Phase 2a trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRX-03140 administered orally once-daily stable dose of 10mg donepezil.
EPIX Pharmaceuticals Reports Preliminary Findings from Phase 1b Clinical Trial of Novel 5-HT6 Drug Candidate
PRX-07034 Results in Significant Weight Loss in Obese Adults;
Conference Call to be Held Today at 4:30 p.m. EDT
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 29, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced statistically significant results from its Phase 1b clinical trial of PRX-07034 in obesity, the company's internally-discovered, novel 5-HT6 antagonist being developed for obesity, Alzheimer's disease and cognitive impairment associated with schizophrenia. Findings from the randomized, double-blind, placebo-controlled trial of 21 obese, but otherwise healthy, adults demonstrated that adults taking 600mg PRX-07034 twice-daily (n=11) for 28 days lost an average of 0.45 kg (1 pound), while adults on placebo (n=10) gained 1.37 kg (3 pounds) during the same period; p less than 0.005.
Key Findings:
-- After 28 days of dosing, the average difference in weight in
the intent-to-treat population between subjects receiving
PRX-07034 and those receiving matched placebo was 1.82kg; p
less than 0.005
-- After 42 days - the 28-day dosing period and a 14-day
follow-up period - subjects on PRX-07034 (n =10) lost an
average of 0.26 kg overall compared to an average of 1.25 kg
gained by placebo (n=10) patients; p less than 0.005
-- PRX-07034 was associated with a significant reduction in serum
leptin levels, a marker of fat stores in the body (p less than
0.036)
-- Overall, only one of the 10 subjects on placebo (10%) lost any
weight during the trial, while seven of the 11 subjects on
PRX-07034 (approximately 64%) lost weight
-- PRX-07034 appeared well-tolerated and there were no serious
adverse events reported; an increase in corrected QT interval
(QTc) was apparent at the dose tested, with a mean increase
over the duration of the study of 10.7 msec for the drug group
versus a decrease of 1.7 msec for the placebo group
"We are very excited about the level of weight loss seen for PRX-07034 in an obesity indication," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "In this 28-day study, not only did the adults on PRX-07034 lose weight while those on placebo gained weight, but they were able to do so without any constraints on eating habits. We also note that subjects in this study did not follow any pre-specified dietary or exercise program."
This Phase 1b trial was designed primarily to study the safety, tolerability and pharmacokinetics of a 600mg dose administered orally twice daily for 28 days in a population of obese, but otherwise healthy, adults (average weight 104.7 kg or 230 pounds).
Although there was evidence of QT prolongation in the ECG in subjects who received drug in the study, there were no corresponding clinical adverse events reported. Further development of the drug is expected to be conducted using the R-enantiomeric form of the drug because the Company believes, based on preclinical data, that the S-enantiomer is predominantly responsible for these QT findings.
Throughout the course of the trial, PRX-07034 appeared well-tolerated and there were no serious adverse events reported. Of the full intent-to-treat population of 21 adults, one patient on drug discontinued the trial due to a rash that resolved rapidly. There were no discontinuations on placebo.
The 21-person trial, which was conducted in an outpatient setting (subjects spent three nights of the total 28-day trial as inpatients to accommodate measurements and physician examinations), included secondary endpoint measures to assess potential effects on body weight, hunger and satiety and exploratory endpoint measures of cognitive function.
EPIX is continuing to gather and analyze findings from the Phase 1b trial, including data for additional secondary and exploratory endpoints including cognitive assessments.
Earlier this year, EPIX reported statistically significant improvements in cognitive function and trends in weight loss from a Phase 1b trial of PRX-07034 in doses up to 600mg once daily administered for 28 days. In that trial, PRX-07034 met the primary endpoint of safety and tolerability with no dose-limiting toxicity, no serious adverse events and no patient withdrawals.
PRX-07034 Selected for TURNS Clinical Trial
EPIX also announced today that PRX-07034 has been selected by the Treatment Units for Research on Neurocognition and Schizophrenia (TURNS), a project of the U.S. National Institute of Mental Health, for a future clinical trial to be conducted in conjunction with TURNS. EPIX will work with TURNS to develop the trial protocol and timeline. TURNS assesses and selects those compounds it feels are important to the study and treatment of neurocognitive disorders and schizophrenia. A collaborative trial could start as early as 2Q08.
PRX-07034 Results in Significant Weight Loss in Obese Adults;
Conference Call to be Held Today at 4:30 p.m. EDT
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 29, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced statistically significant results from its Phase 1b clinical trial of PRX-07034 in obesity, the company's internally-discovered, novel 5-HT6 antagonist being developed for obesity, Alzheimer's disease and cognitive impairment associated with schizophrenia. Findings from the randomized, double-blind, placebo-controlled trial of 21 obese, but otherwise healthy, adults demonstrated that adults taking 600mg PRX-07034 twice-daily (n=11) for 28 days lost an average of 0.45 kg (1 pound), while adults on placebo (n=10) gained 1.37 kg (3 pounds) during the same period; p less than 0.005.
Key Findings:
-- After 28 days of dosing, the average difference in weight in
the intent-to-treat population between subjects receiving
PRX-07034 and those receiving matched placebo was 1.82kg; p
less than 0.005
-- After 42 days - the 28-day dosing period and a 14-day
follow-up period - subjects on PRX-07034 (n =10) lost an
average of 0.26 kg overall compared to an average of 1.25 kg
gained by placebo (n=10) patients; p less than 0.005
-- PRX-07034 was associated with a significant reduction in serum
leptin levels, a marker of fat stores in the body (p less than
0.036)
-- Overall, only one of the 10 subjects on placebo (10%) lost any
weight during the trial, while seven of the 11 subjects on
PRX-07034 (approximately 64%) lost weight
-- PRX-07034 appeared well-tolerated and there were no serious
adverse events reported; an increase in corrected QT interval
(QTc) was apparent at the dose tested, with a mean increase
over the duration of the study of 10.7 msec for the drug group
versus a decrease of 1.7 msec for the placebo group
"We are very excited about the level of weight loss seen for PRX-07034 in an obesity indication," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "In this 28-day study, not only did the adults on PRX-07034 lose weight while those on placebo gained weight, but they were able to do so without any constraints on eating habits. We also note that subjects in this study did not follow any pre-specified dietary or exercise program."
This Phase 1b trial was designed primarily to study the safety, tolerability and pharmacokinetics of a 600mg dose administered orally twice daily for 28 days in a population of obese, but otherwise healthy, adults (average weight 104.7 kg or 230 pounds).
Although there was evidence of QT prolongation in the ECG in subjects who received drug in the study, there were no corresponding clinical adverse events reported. Further development of the drug is expected to be conducted using the R-enantiomeric form of the drug because the Company believes, based on preclinical data, that the S-enantiomer is predominantly responsible for these QT findings.
Throughout the course of the trial, PRX-07034 appeared well-tolerated and there were no serious adverse events reported. Of the full intent-to-treat population of 21 adults, one patient on drug discontinued the trial due to a rash that resolved rapidly. There were no discontinuations on placebo.
The 21-person trial, which was conducted in an outpatient setting (subjects spent three nights of the total 28-day trial as inpatients to accommodate measurements and physician examinations), included secondary endpoint measures to assess potential effects on body weight, hunger and satiety and exploratory endpoint measures of cognitive function.
EPIX is continuing to gather and analyze findings from the Phase 1b trial, including data for additional secondary and exploratory endpoints including cognitive assessments.
Earlier this year, EPIX reported statistically significant improvements in cognitive function and trends in weight loss from a Phase 1b trial of PRX-07034 in doses up to 600mg once daily administered for 28 days. In that trial, PRX-07034 met the primary endpoint of safety and tolerability with no dose-limiting toxicity, no serious adverse events and no patient withdrawals.
PRX-07034 Selected for TURNS Clinical Trial
EPIX also announced today that PRX-07034 has been selected by the Treatment Units for Research on Neurocognition and Schizophrenia (TURNS), a project of the U.S. National Institute of Mental Health, for a future clinical trial to be conducted in conjunction with TURNS. EPIX will work with TURNS to develop the trial protocol and timeline. TURNS assesses and selects those compounds it feels are important to the study and treatment of neurocognitive disorders and schizophrenia. A collaborative trial could start as early as 2Q08.
EPIX Pharmaceuticals Achieves Milestone For Second Discovery Program in Collaboration with GlaxoSmithKline
Three Lead Candidates Identified
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 5, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX) today announced that it has achieved a key milestone related to the second of three discovery programs under its collaboration with GlaxoSmithKline (NYSE:GSK). Using its proprietary, integrated computational-medicinal chemistry approach to drug discovery, EPIX has identified three lead candidates to move forward into lead optimization in this second G-protein coupled receptor (GPCR) discovery program. Under the collaboration, EPIX is entitled to receive a $3 million milestone payment from GSK in the next 30 days. In August, EPIX announced that it had identified three lead candidates for the first discovery program, which entitled the company to a $3 million milestone payment.
"We continue to be pleased by the ongoing progress of our collaboration with GSK and our ability to move these discovery programs forward," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "Our ability to deliver lead candidates for two discovery programs further validates our approach and the productivity of our partnership with GSK. We look forward to continuing our efforts to deliver on our joint goals and achieve key milestones."
"We're very happy that the EPIX in silico approach to drug discovery continues to deliver promising results, in this case three more lead candidates that we will move forward into lead optimization as part of our collaboration with GSK," said Yael Marantz, Ph.D., executive director of computational drug discovery at EPIX. "We are extremely proud of our group and our joint work with GSK - together, we are delivering on joint timelines and goals for our collaborative GPCR discovery programs."
In December 2006, EPIX and GSK announced a worldwide multi-target strategic collaboration to discover, develop and market novel medicines targeting four G-protein coupled receptors (GPCRs) for the treatment of a variety of diseases, including EPIX's novel 5-HT4 partial agonist program, PRX-03140, which is in early-stage clinical development for the treatment of Alzheimer's disease. As part of the collaboration, EPIX received total initial payments of $35 million, including $17.5 million through the purchase of its common stock, and may be eligible to earn up to $1.2 billion in milestones across the four GPCR programs. Under the collaboration, EPIX is also entitled to receive tiered double-digit royalties of sales by GSK on all collaboration-developed product sales. The alliance is conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).
"We continue to be impressed by the quality and efficiency of the lead identification process for this collaborative effort between EPIX and GSK," said Hugh Cowley, M.D., head of GSK's Center of Excellence for External Drug Discovery (CEEDD). "We are moving forward on-schedule and this achievement marks an additional milestone in what we hope will be a long and productive collaboration."
Three Lead Candidates Identified
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 5, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX) today announced that it has achieved a key milestone related to the second of three discovery programs under its collaboration with GlaxoSmithKline (NYSE:GSK). Using its proprietary, integrated computational-medicinal chemistry approach to drug discovery, EPIX has identified three lead candidates to move forward into lead optimization in this second G-protein coupled receptor (GPCR) discovery program. Under the collaboration, EPIX is entitled to receive a $3 million milestone payment from GSK in the next 30 days. In August, EPIX announced that it had identified three lead candidates for the first discovery program, which entitled the company to a $3 million milestone payment.
"We continue to be pleased by the ongoing progress of our collaboration with GSK and our ability to move these discovery programs forward," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "Our ability to deliver lead candidates for two discovery programs further validates our approach and the productivity of our partnership with GSK. We look forward to continuing our efforts to deliver on our joint goals and achieve key milestones."
"We're very happy that the EPIX in silico approach to drug discovery continues to deliver promising results, in this case three more lead candidates that we will move forward into lead optimization as part of our collaboration with GSK," said Yael Marantz, Ph.D., executive director of computational drug discovery at EPIX. "We are extremely proud of our group and our joint work with GSK - together, we are delivering on joint timelines and goals for our collaborative GPCR discovery programs."
In December 2006, EPIX and GSK announced a worldwide multi-target strategic collaboration to discover, develop and market novel medicines targeting four G-protein coupled receptors (GPCRs) for the treatment of a variety of diseases, including EPIX's novel 5-HT4 partial agonist program, PRX-03140, which is in early-stage clinical development for the treatment of Alzheimer's disease. As part of the collaboration, EPIX received total initial payments of $35 million, including $17.5 million through the purchase of its common stock, and may be eligible to earn up to $1.2 billion in milestones across the four GPCR programs. Under the collaboration, EPIX is also entitled to receive tiered double-digit royalties of sales by GSK on all collaboration-developed product sales. The alliance is conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).
"We continue to be impressed by the quality and efficiency of the lead identification process for this collaborative effort between EPIX and GSK," said Hugh Cowley, M.D., head of GSK's Center of Excellence for External Drug Discovery (CEEDD). "We are moving forward on-schedule and this achievement marks an additional milestone in what we hope will be a long and productive collaboration."
EPIX Pharmaceuticals Announces Third Quarter Financial Results
Recent Achievements Include Positive Data in Obesity and PH with COPD, Milestones Reached with GSK and CFFT
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 6, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX) today reported financial results for the third quarter ended September 30, 2007.
"This was a significant quarter for EPIX - one that was marked by clinical successes, pipeline progress and corporate growth," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "We are excited by the results of our Phase 1b clinical trial of PRX-07034 in obesity and our Phase 2a clinical trial of PRX-08066 in patients with pulmonary hypertension (PH) associated with COPD. We've also achieved key milestones under our strategic collaborations with GlaxoSmithKline and Cystic Fibrosis Foundation Therapeutics, and have completed enrollment into both our Phase 2b trial of PRX-00023 in major depressive disorder and our Phase 2a trial of PRX-03140 in Alzheimer's disease. We are continuing to advance our programs on-schedule and deliver on key corporate goals."
EPIX Recent Corporate Highlights:
Positive Phase 1b Weight Loss Data for PRX-07034 in Obesity
In October, EPIX announced statistically significant results (p is less than 0.005) from its Phase 1b clinical trial of PRX-07034, the company's internally-discovered, novel 5-HT6 antagonist being developed for obesity, Alzheimer's disease and cognitive impairment associated with schizophrenia. Findings from the randomized, double-blind, placebo-controlled trial of 21 obese, but otherwise healthy, adults demonstrated that patients taking PRX-07034 (n=11) for 28 days lost an average of 0.45 kg, while patients on placebo (n=10) gained 1.37 kg during this period. An increase in corrected QT wave interval was apparent at the dose tested but, based on pre-clinical data, the company believes that this effect can be reduced by continuing the development of the compound in an isomeric (i.e., one enantiomer) form rather than the racemic form used in this trial.
Clinical Program Updates
In October, EPIX also provided key clinical program updates. EPIX announced the completion of patient enrollment in its Phase 2b trial of PRX-00023 in major depressive disorder (MDD). The company expects to announce study results in the first quarter of 2008. Further, EPIX announced that it completed patient enrollment and expects to report findings from its Phase 2a clinical trial of PRX-03140 in Alzheimer's disease by the end of 2007.
Final data from Phase 2a clinical trial of PRX-08066
In August, EPIX announced final results from its Phase 2a clinical trial of PRX-08066 in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD). This randomized, double-blind, placebo-controlled trial of 71 patients resulted in statistically significant (p=0.043) reductions in systolic pulmonary artery pressure (SPAP). Responder (defined as greater than or equal to a 4mmHg drop in SPAP) rates were 45% on 400 mg once-daily vs. 14% on placebo. PRX-08066 also was well-tolerated and demonstrated the potential for co-administration with other therapies. Based on the top-line results from this trial, the company intends to continue the development of PRX-08066 as a first-in-class 5-HT2B antagonist in PH associated with COPD.
Expansion of Regulatory Affairs Management Team
In August, EPIX announced the expansion of the company's research and development team with the appointment of Margaret Uprichard, PharmD, to the position of senior vice president, regulatory affairs and quality. Dr. Uprichard is now responsible for leading all regulatory affairs activities for the company, including developing and maintaining effective regulatory strategies for EPIX's five lead product candidates currently in clinical trials.
Milestone Achievements with GlaxoSmithKline
Under its collaboration with GlaxoSmithKline (NYSE:GSK), EPIX announced in August and November that it reached initial milestones related to the first and second of three discovery stage programs. Using its proprietary, integrated computational-medicinal chemistry approach to drug discovery, EPIX identified three lead candidates to move forward into lead optimization in each of these first two collaborative G-protein coupled receptor (GPCR) discovery programs. In addition to the three joint discovery programs, EPIX and GSK maintain a joint focus on developing PRX-03140, EPIX's proprietary 5-HT4 agonist, for the treatment of Alzheimer's disease. The companies are continuing their efforts on the three discovery program targets, as well as on the achievement of key milestones across all collaborative programs.
Third Milestone Achievement with Cystic Fibrosis Foundation Therapeutics (CFFT)
As part of its collaboration with CFFT, EPIX announced in August that it had successfully identified a hit compound that corrects the functionality of the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) ion channel in a cell-based model system. A mutation in the CFTR gene is one of the key factors that ultimately lead to the symptoms, complications and premature mortality in people with CF.
Approval of Vasovist in Turkey and Marketing Launch in CanadaEPIX is also announcing that its novel blood pool imaging agent Vasovist has been approved for marketing in Turkey and that marketing of Vasovist has been launched by its partner Bayer HealthCare Pharmaceuticals in Canada. Vasovist is now approved for marketing in more than 30 countries worldwide, including all 27 member states of the European Union, Norway, Iceland, Switzerland, Australia and Canada. EPIX is making progress in its discussions with the FDA regarding its NDA for Vasovist and expects to initiate its re-read protocol and analysis in early 2008.
Financial Results
Net loss for the third quarter of 2007 was $12.9 million, or $0.39 per share, versus $133.1 million, or $6.00 per share, for the same period in 2006. The decrease in the net loss was primarily due to a non-recurring charge of $123.5 million recorded for in-process research and development in the third quarter of 2006.
Total revenues in the third quarter of 2007 were $5.3 million, compared to $1.3 million in the third quarter of 2006. Research and development expenses totaled $14.9 million in the third quarter of 2007, compared to $7.9 million in the third quarter of 2006. The increase in research and development expenses was primarily attributable to expenses associated with the company's five ongoing clinical development programs, as well as preclinical programs and internal costs, which began after the acquisition of Predix Pharmaceuticals Holdings, Inc. was completed on August 16, 2006.
General and administrative expense was $3.6 million in the third quarter of 2007 compared to $3.1 million in the third quarter of 2006. The increase in general and administrative expense was primarily due to costs associated with the increase in personnel and infrastructure relating to the Predix acquisition. Additionally, EPIX incurred greater legal expenses, including for patent-related matters, due to the increased complexity of the post-merger company.
As of September 30, 2007, EPIX had cash, cash equivalents and short-term investments of $66.1 million compared to $109.5 million on December 31, 2006. Management estimates that cash, cash equivalents and marketable securities on hand as of September 30, 2007, together with anticipated revenue earned in 2007 and 2008, will fund operations through 2008.
EPIX currently has $100.0 million of convertible debt outstanding. Approximately 32.9 million shares of common stock were outstanding at September 30, 2007. On October 29, 2007, EPIX issued 3,167,000 common shares and paid approximately $5.8 million in cash in full satisfaction of the second and final milestone payment to the former Predix shareholders.
Dr. Kauffman added, "We are looking forward to continuing our progress and delivering on additional corporate milestones. By the end of the year, we expect to announce the results of our Phase 2a trial of PRX-03140 in Alzheimer's disease. Moving into 2008, we anticipate continued achievements and are on-schedule to report our Phase 2b trial results of PRX-00023 in depression in the first quarter of that year."
Upcoming Milestones
-- Results from Phase 2a trial of PRX-03140 in Alzheimer's
disease expected 4Q07
-- Initiation of Phase 2b right-heart catheter study in PRX-08066
program expected 1Q08
-- Results from Phase 2b trial of PRX-00023 in major depressive
disorder expected 1Q08
-- Initiation of Phase 2b trial of PRX-03140 in combination with
Aricept(R) in Alzheimer's disease expected 1H08
Recent Achievements Include Positive Data in Obesity and PH with COPD, Milestones Reached with GSK and CFFT
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 6, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX) today reported financial results for the third quarter ended September 30, 2007.
"This was a significant quarter for EPIX - one that was marked by clinical successes, pipeline progress and corporate growth," said Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "We are excited by the results of our Phase 1b clinical trial of PRX-07034 in obesity and our Phase 2a clinical trial of PRX-08066 in patients with pulmonary hypertension (PH) associated with COPD. We've also achieved key milestones under our strategic collaborations with GlaxoSmithKline and Cystic Fibrosis Foundation Therapeutics, and have completed enrollment into both our Phase 2b trial of PRX-00023 in major depressive disorder and our Phase 2a trial of PRX-03140 in Alzheimer's disease. We are continuing to advance our programs on-schedule and deliver on key corporate goals."
EPIX Recent Corporate Highlights:
Positive Phase 1b Weight Loss Data for PRX-07034 in Obesity
In October, EPIX announced statistically significant results (p is less than 0.005) from its Phase 1b clinical trial of PRX-07034, the company's internally-discovered, novel 5-HT6 antagonist being developed for obesity, Alzheimer's disease and cognitive impairment associated with schizophrenia. Findings from the randomized, double-blind, placebo-controlled trial of 21 obese, but otherwise healthy, adults demonstrated that patients taking PRX-07034 (n=11) for 28 days lost an average of 0.45 kg, while patients on placebo (n=10) gained 1.37 kg during this period. An increase in corrected QT wave interval was apparent at the dose tested but, based on pre-clinical data, the company believes that this effect can be reduced by continuing the development of the compound in an isomeric (i.e., one enantiomer) form rather than the racemic form used in this trial.
Clinical Program Updates
In October, EPIX also provided key clinical program updates. EPIX announced the completion of patient enrollment in its Phase 2b trial of PRX-00023 in major depressive disorder (MDD). The company expects to announce study results in the first quarter of 2008. Further, EPIX announced that it completed patient enrollment and expects to report findings from its Phase 2a clinical trial of PRX-03140 in Alzheimer's disease by the end of 2007.
Final data from Phase 2a clinical trial of PRX-08066
In August, EPIX announced final results from its Phase 2a clinical trial of PRX-08066 in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD). This randomized, double-blind, placebo-controlled trial of 71 patients resulted in statistically significant (p=0.043) reductions in systolic pulmonary artery pressure (SPAP). Responder (defined as greater than or equal to a 4mmHg drop in SPAP) rates were 45% on 400 mg once-daily vs. 14% on placebo. PRX-08066 also was well-tolerated and demonstrated the potential for co-administration with other therapies. Based on the top-line results from this trial, the company intends to continue the development of PRX-08066 as a first-in-class 5-HT2B antagonist in PH associated with COPD.
Expansion of Regulatory Affairs Management Team
In August, EPIX announced the expansion of the company's research and development team with the appointment of Margaret Uprichard, PharmD, to the position of senior vice president, regulatory affairs and quality. Dr. Uprichard is now responsible for leading all regulatory affairs activities for the company, including developing and maintaining effective regulatory strategies for EPIX's five lead product candidates currently in clinical trials.
Milestone Achievements with GlaxoSmithKline
Under its collaboration with GlaxoSmithKline (NYSE:GSK), EPIX announced in August and November that it reached initial milestones related to the first and second of three discovery stage programs. Using its proprietary, integrated computational-medicinal chemistry approach to drug discovery, EPIX identified three lead candidates to move forward into lead optimization in each of these first two collaborative G-protein coupled receptor (GPCR) discovery programs. In addition to the three joint discovery programs, EPIX and GSK maintain a joint focus on developing PRX-03140, EPIX's proprietary 5-HT4 agonist, for the treatment of Alzheimer's disease. The companies are continuing their efforts on the three discovery program targets, as well as on the achievement of key milestones across all collaborative programs.
Third Milestone Achievement with Cystic Fibrosis Foundation Therapeutics (CFFT)
As part of its collaboration with CFFT, EPIX announced in August that it had successfully identified a hit compound that corrects the functionality of the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) ion channel in a cell-based model system. A mutation in the CFTR gene is one of the key factors that ultimately lead to the symptoms, complications and premature mortality in people with CF.
Approval of Vasovist in Turkey and Marketing Launch in CanadaEPIX is also announcing that its novel blood pool imaging agent Vasovist has been approved for marketing in Turkey and that marketing of Vasovist has been launched by its partner Bayer HealthCare Pharmaceuticals in Canada. Vasovist is now approved for marketing in more than 30 countries worldwide, including all 27 member states of the European Union, Norway, Iceland, Switzerland, Australia and Canada. EPIX is making progress in its discussions with the FDA regarding its NDA for Vasovist and expects to initiate its re-read protocol and analysis in early 2008.
Financial Results
Net loss for the third quarter of 2007 was $12.9 million, or $0.39 per share, versus $133.1 million, or $6.00 per share, for the same period in 2006. The decrease in the net loss was primarily due to a non-recurring charge of $123.5 million recorded for in-process research and development in the third quarter of 2006.
Total revenues in the third quarter of 2007 were $5.3 million, compared to $1.3 million in the third quarter of 2006. Research and development expenses totaled $14.9 million in the third quarter of 2007, compared to $7.9 million in the third quarter of 2006. The increase in research and development expenses was primarily attributable to expenses associated with the company's five ongoing clinical development programs, as well as preclinical programs and internal costs, which began after the acquisition of Predix Pharmaceuticals Holdings, Inc. was completed on August 16, 2006.
General and administrative expense was $3.6 million in the third quarter of 2007 compared to $3.1 million in the third quarter of 2006. The increase in general and administrative expense was primarily due to costs associated with the increase in personnel and infrastructure relating to the Predix acquisition. Additionally, EPIX incurred greater legal expenses, including for patent-related matters, due to the increased complexity of the post-merger company.
As of September 30, 2007, EPIX had cash, cash equivalents and short-term investments of $66.1 million compared to $109.5 million on December 31, 2006. Management estimates that cash, cash equivalents and marketable securities on hand as of September 30, 2007, together with anticipated revenue earned in 2007 and 2008, will fund operations through 2008.
EPIX currently has $100.0 million of convertible debt outstanding. Approximately 32.9 million shares of common stock were outstanding at September 30, 2007. On October 29, 2007, EPIX issued 3,167,000 common shares and paid approximately $5.8 million in cash in full satisfaction of the second and final milestone payment to the former Predix shareholders.
Dr. Kauffman added, "We are looking forward to continuing our progress and delivering on additional corporate milestones. By the end of the year, we expect to announce the results of our Phase 2a trial of PRX-03140 in Alzheimer's disease. Moving into 2008, we anticipate continued achievements and are on-schedule to report our Phase 2b trial results of PRX-00023 in depression in the first quarter of that year."
Upcoming Milestones
-- Results from Phase 2a trial of PRX-03140 in Alzheimer's
disease expected 4Q07
-- Initiation of Phase 2b right-heart catheter study in PRX-08066
program expected 1Q08
-- Results from Phase 2b trial of PRX-00023 in major depressive
disorder expected 1Q08
-- Initiation of Phase 2b trial of PRX-03140 in combination with
Aricept(R) in Alzheimer's disease expected 1H08
Antwort auf Beitrag Nr.: 32.327.789 von Erbse1 am 07.11.07 17:02:51EPIX to Raise $16.3 Million through Private Financing
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 12, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced it has entered into definitive agreements with institutional and accredited investors with respect to the private placement of approximately 5.2 million shares of its common stock at a purchase price of $3.10 per share for expected gross proceeds of approximately $16.3 million before payment of placement agent commissions and offering expenses. EPIX expects to utilize the proceeds to finance ongoing clinical trials, advance its research and development activities and fund general corporate operations. Closing is expected to occur on or about November 15, 2007, subject to customary closing conditions.
The shares of common stock sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from the registration requirements. The shares were offered and sold only to institutional and accredited investors. EPIX has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issued in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer will be made only by means of a prospectus, forming a part of the effective registration statement. Copies of the final prospectus can be obtained at the SEC website at http://www.sec.gov or at the EPIX website at www.epixpharma.com.
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 12, 2007--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced it has entered into definitive agreements with institutional and accredited investors with respect to the private placement of approximately 5.2 million shares of its common stock at a purchase price of $3.10 per share for expected gross proceeds of approximately $16.3 million before payment of placement agent commissions and offering expenses. EPIX expects to utilize the proceeds to finance ongoing clinical trials, advance its research and development activities and fund general corporate operations. Closing is expected to occur on or about November 15, 2007, subject to customary closing conditions.
The shares of common stock sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from the registration requirements. The shares were offered and sold only to institutional and accredited investors. EPIX has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issued in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer will be made only by means of a prospectus, forming a part of the effective registration statement. Copies of the final prospectus can be obtained at the SEC website at http://www.sec.gov or at the EPIX website at www.epixpharma.com.
EPIX Pharmaceuticals Reports Compelling Clinical Results for PRX-03140 in Alzheimer's Disease; Statistically Significant Improvement in Cognitive Function Achieved Within Two Weeks
EPIX to Host Investor Conference Call Today at 10:30 a.m. EST to Discuss Results
LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 18, 2007--EPIX Pharmaceuticals (NASDAQ: EPIX), today announced compelling top-line results from a Phase 2a two-week clinical trial of its novel 5-HT4 agonist, PRX-03140, in patients with Alzheimer's disease. The results show that patients receiving 150 mg of PRX-03140 orally once daily as monotherapy achieved a mean 5.7 point improvement on the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) versus a 0.2 point worsening in patients on placebo (p= 0.005). Patients on a 50 mg dose of PRX-03140 showed a 1.1 point improvement on the ADAS-cog. The ADAS-cog endpoint is the current standard for evaluating drug efficacy for cognition in Alzheimer's disease and is an established and accepted registration endpoint.
"The responses observed in this clinical trial over a short duration are promising, and clearly indicate that PRX-03140 is worthy of further study over a longer period and in a larger patient population," stated Paul Solomon, Ph.D., Professor, Department of Psychology and Program in the Neurosciences, Williams College, and the Clinical Director of the Memory Clinic in Bennington, Vermont. "Our patients are always in need of safe and effective treatments for Alzheimer's disease, and I am very encouraged by these data."
After reviewing these data, Serge Gauthier, M.D., Director of the Alzheimer's Disease Research Unit at McGill University, stated, "There is such an urgent and undeniable need for additional safe and effective treatments for Alzheimer's patients. Findings like these data are not only encouraging and compelling - they appear to represent a step forward in our ability to understand and combat the effects of Alzheimer's. I look forward to the next clinical trial of PRX-03140 as the development of this drug could be an important advance toward effective Alzheimer's treatment."
This Phase 2a clinical trial was a randomized, double-blind, placebo-controlled study to assess the effects of PRX-03140 following two weeks of treatment as monotherapy and separately in combination with donepezil (Aricept(R)) in patients with mild Alzheimer's disease. PRX-03140 appeared to be well tolerated alone and in combination with donepezil (Aricept(R)) with no serious drug-related adverse events. The results show that patients on PRX-03140 alone achieved a statistically significant improvement in ADAS-cog; ADAS-cog changes in the combination arms of the trial were not statistically significant. According to the literature supporting currently approved Alzheimer's therapies, significant improvements in ADAS-cog measures are not typically observed in less than 12 weeks of therapy.
"We had several responses of note in this trial," stated Marvin Kalafer, M.D., Principal Investigator at The Clinical Trial Center in Jenkintown, Pennsylvania. "The compelling efficacy and tolerability data observed in this two-week trial are indicative of a profile that would be highly differentiated in the category."
In pre-clinical models, PRX-03140 has been shown to have a novel mechanism of action that differentiates it from current Alzheimer's therapies. This oral drug candidate selectively activates the 5-HT4 receptor in the brain. Activation of 5-HT4 not only stimulates the production/release of acetylcholine, which may improve cognitive symptoms of Alzheimer's, but also stimulates the alpha secretase pathway, potentially slowing disease progression. PRX-03140 has the potential to be the first-in-class 5-HT4 agonist for the treatment of Alzheimer's disease.
Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX Pharmaceuticals stated, "We are very excited by the measurable impact on memory and cognition, achieved in such a short period of time, in a trial that was designed primarily to assess safety and tolerability. While we recognize that this is a two-week study on a relatively small population of patients, these statistically significant results, as well as the anecdotal reports we have received from study investigators and patients' families since the trial concluded, support our belief that PRX-03140 has the potential to improve memory and cognition. We look forward to initiating a larger Phase 2b clinical trial early next year to further explore the potential of PRX-03140."
Trial Design and Results
This Phase 2a clinical trial was conducted across 17 U.S. sites and included 80 patients who were treated for two weeks. Patients were studied on PRX-03140 alone (across three dose arms of 10 patients each: 50 mg once-daily, 150 mg once-daily and placebo) or in a placebo-controlled combination with 10 mg donepezil (Aricept(R)) (across five dose arms of 10 patients each: PRX-03140 at 5, 25, 50, 100 and 200 mg with donepezil (Aricept(R))10 mg once-daily). Primary endpoints were safety, tolerability and assessment of quantitative electroencephalograms (qEEG). A battery of cognitive measures, including ADAS-cog assessment, and pharmacokinetic evaluations were measured as secondary endpoints.
Key trial findings include:
-- Robust and statistically significant improvement in cognitive
function as measured by ADAS-cog with PRX-03140 at 150 mg
once-daily monotherapy vs. placebo (p=0.005); the rigorous
analysis of covariance with the ADAS-cog baseline was used
-- This 5.7-point mean improvement in ADAS-cog for the 150 mg
dose group compared to a 0.2-point mean worsening on placebo
is better than ADAS-cog responses seen in previously published
information with approved and experimental agents
-- PRX-03140 also showed a statistically significant
dose-response for 150 mg vs. 50 mg (monotherapy) vs. placebo
(p=0.02)
-- The onset of benefit of PRX-03140 in Alzheimer's patients was
observed within two weeks
-- PRX-03140 produced strong trends in the alteration in brain
wave activity (alpha:theta ratio) in the 150 mg dose group
versus placebo as measured by qEEG, similar to changes
observed with cholinesterase inhibitors
-- As monotherapy and in combination with donepezil (Aricept(R)),
PRX-03140 appeared to be well-tolerated with no serious
drug-related adverse events
PRX-03140 is part of EPIX's worldwide, multi-target strategic collaboration with GlaxoSmithKline to discover, develop and market novel medicines targeting four G-protein coupled receptors (GPCR) for the treatment of a variety of diseases, including Alzheimer's disease. EPIX is responsible for discovery and development of products in the collaboration, including PRX-03140, through to clinical proof of concept, at which point GSK has an exclusive option to license each product for further development and commercialization on a worldwide basis. As part of the collaboration, EPIX received total initial payments of $35 million, including $17.5 million through the purchase of its common stock, and may be eligible to earn up to $1.2 billion in milestones across the four GPCR programs. If GSK exercises the option to license EPIX's PRX-03140 program, EPIX will retain the right to co-promote any products from that program in the United States. Under the collaboration, EPIX is also entitled to receive tiered double-digit royalties of sales by GSK on all collaboration-developed product sales. The alliance is conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).
About PRX-03140
PRX-03140 is a novel, oral investigational drug candidate for Alzheimer's disease. It is selective for the 5-HT4 receptor in the brain and is believed to stimulate both acetylcholine production/release - which enables symptomatic improvement in Alzheimer's patients - and the alpha-secretase pathway - which slows Alzheimer's disease progression. In three Phase 1 trials and this Phase 2a trial, with more than 180 patients and healthy subjects, PRX-03140 has been well-tolerated. In a 14-day Phase 1b clinical trial, treatment with PRX-03140 resulted in changes in brain wave activity in Alzheimer's patients that are consistent with those seen in clinical trials with currently approved drugs for Alzheimer's disease. In preclinical studies, PRX-03140 has shown to improve cognitive function through increasing levels of acetylcholine, soluble amyloid precursor protein (sAPP) and brain-derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory.
PRX-03140 is one of EPIX's four drug candidates currently in clinical trials discovered through the use of its proprietary computer-based G-Protein Coupled Receptors (GPCR) platform and optimized with integrated computational-medicinal chemistry.
EPIX to Host Investor Conference Call Today at 10:30 a.m. EST to Discuss Results
LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 18, 2007--EPIX Pharmaceuticals (NASDAQ: EPIX), today announced compelling top-line results from a Phase 2a two-week clinical trial of its novel 5-HT4 agonist, PRX-03140, in patients with Alzheimer's disease. The results show that patients receiving 150 mg of PRX-03140 orally once daily as monotherapy achieved a mean 5.7 point improvement on the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) versus a 0.2 point worsening in patients on placebo (p= 0.005). Patients on a 50 mg dose of PRX-03140 showed a 1.1 point improvement on the ADAS-cog. The ADAS-cog endpoint is the current standard for evaluating drug efficacy for cognition in Alzheimer's disease and is an established and accepted registration endpoint.
"The responses observed in this clinical trial over a short duration are promising, and clearly indicate that PRX-03140 is worthy of further study over a longer period and in a larger patient population," stated Paul Solomon, Ph.D., Professor, Department of Psychology and Program in the Neurosciences, Williams College, and the Clinical Director of the Memory Clinic in Bennington, Vermont. "Our patients are always in need of safe and effective treatments for Alzheimer's disease, and I am very encouraged by these data."
After reviewing these data, Serge Gauthier, M.D., Director of the Alzheimer's Disease Research Unit at McGill University, stated, "There is such an urgent and undeniable need for additional safe and effective treatments for Alzheimer's patients. Findings like these data are not only encouraging and compelling - they appear to represent a step forward in our ability to understand and combat the effects of Alzheimer's. I look forward to the next clinical trial of PRX-03140 as the development of this drug could be an important advance toward effective Alzheimer's treatment."
This Phase 2a clinical trial was a randomized, double-blind, placebo-controlled study to assess the effects of PRX-03140 following two weeks of treatment as monotherapy and separately in combination with donepezil (Aricept(R)) in patients with mild Alzheimer's disease. PRX-03140 appeared to be well tolerated alone and in combination with donepezil (Aricept(R)) with no serious drug-related adverse events. The results show that patients on PRX-03140 alone achieved a statistically significant improvement in ADAS-cog; ADAS-cog changes in the combination arms of the trial were not statistically significant. According to the literature supporting currently approved Alzheimer's therapies, significant improvements in ADAS-cog measures are not typically observed in less than 12 weeks of therapy.
"We had several responses of note in this trial," stated Marvin Kalafer, M.D., Principal Investigator at The Clinical Trial Center in Jenkintown, Pennsylvania. "The compelling efficacy and tolerability data observed in this two-week trial are indicative of a profile that would be highly differentiated in the category."
In pre-clinical models, PRX-03140 has been shown to have a novel mechanism of action that differentiates it from current Alzheimer's therapies. This oral drug candidate selectively activates the 5-HT4 receptor in the brain. Activation of 5-HT4 not only stimulates the production/release of acetylcholine, which may improve cognitive symptoms of Alzheimer's, but also stimulates the alpha secretase pathway, potentially slowing disease progression. PRX-03140 has the potential to be the first-in-class 5-HT4 agonist for the treatment of Alzheimer's disease.
Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX Pharmaceuticals stated, "We are very excited by the measurable impact on memory and cognition, achieved in such a short period of time, in a trial that was designed primarily to assess safety and tolerability. While we recognize that this is a two-week study on a relatively small population of patients, these statistically significant results, as well as the anecdotal reports we have received from study investigators and patients' families since the trial concluded, support our belief that PRX-03140 has the potential to improve memory and cognition. We look forward to initiating a larger Phase 2b clinical trial early next year to further explore the potential of PRX-03140."
Trial Design and Results
This Phase 2a clinical trial was conducted across 17 U.S. sites and included 80 patients who were treated for two weeks. Patients were studied on PRX-03140 alone (across three dose arms of 10 patients each: 50 mg once-daily, 150 mg once-daily and placebo) or in a placebo-controlled combination with 10 mg donepezil (Aricept(R)) (across five dose arms of 10 patients each: PRX-03140 at 5, 25, 50, 100 and 200 mg with donepezil (Aricept(R))10 mg once-daily). Primary endpoints were safety, tolerability and assessment of quantitative electroencephalograms (qEEG). A battery of cognitive measures, including ADAS-cog assessment, and pharmacokinetic evaluations were measured as secondary endpoints.
Key trial findings include:
-- Robust and statistically significant improvement in cognitive
function as measured by ADAS-cog with PRX-03140 at 150 mg
once-daily monotherapy vs. placebo (p=0.005); the rigorous
analysis of covariance with the ADAS-cog baseline was used
-- This 5.7-point mean improvement in ADAS-cog for the 150 mg
dose group compared to a 0.2-point mean worsening on placebo
is better than ADAS-cog responses seen in previously published
information with approved and experimental agents
-- PRX-03140 also showed a statistically significant
dose-response for 150 mg vs. 50 mg (monotherapy) vs. placebo
(p=0.02)
-- The onset of benefit of PRX-03140 in Alzheimer's patients was
observed within two weeks
-- PRX-03140 produced strong trends in the alteration in brain
wave activity (alpha:theta ratio) in the 150 mg dose group
versus placebo as measured by qEEG, similar to changes
observed with cholinesterase inhibitors
-- As monotherapy and in combination with donepezil (Aricept(R)),
PRX-03140 appeared to be well-tolerated with no serious
drug-related adverse events
PRX-03140 is part of EPIX's worldwide, multi-target strategic collaboration with GlaxoSmithKline to discover, develop and market novel medicines targeting four G-protein coupled receptors (GPCR) for the treatment of a variety of diseases, including Alzheimer's disease. EPIX is responsible for discovery and development of products in the collaboration, including PRX-03140, through to clinical proof of concept, at which point GSK has an exclusive option to license each product for further development and commercialization on a worldwide basis. As part of the collaboration, EPIX received total initial payments of $35 million, including $17.5 million through the purchase of its common stock, and may be eligible to earn up to $1.2 billion in milestones across the four GPCR programs. If GSK exercises the option to license EPIX's PRX-03140 program, EPIX will retain the right to co-promote any products from that program in the United States. Under the collaboration, EPIX is also entitled to receive tiered double-digit royalties of sales by GSK on all collaboration-developed product sales. The alliance is conducted through GSK's Center of Excellence for External Drug Discovery (CEEDD).
About PRX-03140
PRX-03140 is a novel, oral investigational drug candidate for Alzheimer's disease. It is selective for the 5-HT4 receptor in the brain and is believed to stimulate both acetylcholine production/release - which enables symptomatic improvement in Alzheimer's patients - and the alpha-secretase pathway - which slows Alzheimer's disease progression. In three Phase 1 trials and this Phase 2a trial, with more than 180 patients and healthy subjects, PRX-03140 has been well-tolerated. In a 14-day Phase 1b clinical trial, treatment with PRX-03140 resulted in changes in brain wave activity in Alzheimer's patients that are consistent with those seen in clinical trials with currently approved drugs for Alzheimer's disease. In preclinical studies, PRX-03140 has shown to improve cognitive function through increasing levels of acetylcholine, soluble amyloid precursor protein (sAPP) and brain-derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory.
PRX-03140 is one of EPIX's four drug candidates currently in clinical trials discovered through the use of its proprietary computer-based G-Protein Coupled Receptors (GPCR) platform and optimized with integrated computational-medicinal chemistry.
Antwort auf Beitrag Nr.: 32.803.028 von Erbse1 am 18.12.07 14:57:46Zu den Ergebnissen von PRX 03140 noch das Schaubild
Ein kleiner Artikel zu den Ergebnissen von PRX-03140
What Was That Clinical Trial For?
By Brian Orelli December 20, 2007
EPIX Pharmaceuticals (Nasdaq: EPIX) initiated a phase 2A study of its Alzheimer's disease drug, PRX-03140, to get safety and tolerability information. Instead, it got much more than it had bargained for.
In a two-week trial, the 150 mg dose of PRX-03140 achieved a mean 5.7 point improvement on the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog). That's pretty darn impressive -- Alzheimer's drugs usually demonstrate a three- to four-point improvement after a full 12 to 24 weeks in clinical studies.
With only 10 subjects receiving each dose level of the drug (150 mg, 50 mg, placebo), the 150 mg treatment arm showed a statistically significant improvement compared to subjects receiving the placebo. The latter had a 0.2 point worsening in their ADAS-cog score.
The data point I like even more is the 50 mg dose of PRX-03140, which showed a 1.1 point improvement on the ADAS-cog. While that's not as impressive as the 150 mg dose -- and the smaller dose won't likely be used in future studies -- it demonstrates that there's a dose response to the drug, which lends confidence to the argument that the effects of the 150 mg dose aren't a fluke.
In the study, PRX-03140 was also tested in combination with Eiasi's and Pfizer's (NYSE: PFE) Aricept, but the addition of PRX-03140 didn't statistically change the ADAS-cog score. Aricept is thought to act by preventing the loss of acetylcholine, a molecule that improves cognitive symptoms of Alzheimer's disease.
PRX-03140, on the other hand, is believed to increase the production of acetylcholine. The idea of putting the two together made perfect sense, and it was hoped that the combination would have a stronger effect than either one alone. Unfortunately, that didn't happen. One explanation is that the patients taking Aricept were already in better shape, and therefore it would take a longer study to show any improvement from adding PRX-03140.
As for the original safety goals? It passed.
EPIX plans to initiate a larger and longer phase 2B clinical trial of PRX-3140 in the first half of 2008. If that data is as strong as the phase 2A data, GlaxoSmithKline (NYSE: GSK) will almost certainly exercise its option to pick up the compound for further development. With compounds such as Novartis' (NYSE: NVS) Exelon and Johnson & Johnson's (NYSE: JNJ) Razadyne producing fair but certainly not stellar results, PRX-03140 could pick up a substantial chunk of the $4 billion market.
Even after the run-up in stock price Tuesday, Epix has a market cap of less than $150 million. That's a pretty fair value for a company with a few phase 2 candidates, including one that could storm onto the Alzheimer's-disease marketplace if it keeps up these strong results
What Was That Clinical Trial For?
By Brian Orelli December 20, 2007
EPIX Pharmaceuticals (Nasdaq: EPIX) initiated a phase 2A study of its Alzheimer's disease drug, PRX-03140, to get safety and tolerability information. Instead, it got much more than it had bargained for.
In a two-week trial, the 150 mg dose of PRX-03140 achieved a mean 5.7 point improvement on the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog). That's pretty darn impressive -- Alzheimer's drugs usually demonstrate a three- to four-point improvement after a full 12 to 24 weeks in clinical studies.
With only 10 subjects receiving each dose level of the drug (150 mg, 50 mg, placebo), the 150 mg treatment arm showed a statistically significant improvement compared to subjects receiving the placebo. The latter had a 0.2 point worsening in their ADAS-cog score.
The data point I like even more is the 50 mg dose of PRX-03140, which showed a 1.1 point improvement on the ADAS-cog. While that's not as impressive as the 150 mg dose -- and the smaller dose won't likely be used in future studies -- it demonstrates that there's a dose response to the drug, which lends confidence to the argument that the effects of the 150 mg dose aren't a fluke.
In the study, PRX-03140 was also tested in combination with Eiasi's and Pfizer's (NYSE: PFE) Aricept, but the addition of PRX-03140 didn't statistically change the ADAS-cog score. Aricept is thought to act by preventing the loss of acetylcholine, a molecule that improves cognitive symptoms of Alzheimer's disease.
PRX-03140, on the other hand, is believed to increase the production of acetylcholine. The idea of putting the two together made perfect sense, and it was hoped that the combination would have a stronger effect than either one alone. Unfortunately, that didn't happen. One explanation is that the patients taking Aricept were already in better shape, and therefore it would take a longer study to show any improvement from adding PRX-03140.
As for the original safety goals? It passed.
EPIX plans to initiate a larger and longer phase 2B clinical trial of PRX-3140 in the first half of 2008. If that data is as strong as the phase 2A data, GlaxoSmithKline (NYSE: GSK) will almost certainly exercise its option to pick up the compound for further development. With compounds such as Novartis' (NYSE: NVS) Exelon and Johnson & Johnson's (NYSE: JNJ) Razadyne producing fair but certainly not stellar results, PRX-03140 could pick up a substantial chunk of the $4 billion market.
Even after the run-up in stock price Tuesday, Epix has a market cap of less than $150 million. That's a pretty fair value for a company with a few phase 2 candidates, including one that could storm onto the Alzheimer's-disease marketplace if it keeps up these strong results
Interessante neue Patentanmeldung zusammen mit Bayer-Schering
USE OF PERFLUORALKYL-CONTAINING METAL COMPLEXES AS CONTRAST AGENTS FOR DIAGNOSING ALZHEIMER'S DISEASE
Abstract of WO2007128567
The invention relates to the use of metal complexes which contain at least one perfluorated alkyl group, at least one chelating agent group, and at least one metal ion equivalent of an element of atomic numbers 21-29, 31-33, 37-39, 42-44, 49 or 57-83, and salts thereof for producing a diagnostic agent for imaging amyloid-containing plaques.
Quelle: http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=WO2007128567&F…
USE OF PERFLUORALKYL-CONTAINING METAL COMPLEXES AS CONTRAST AGENTS FOR DIAGNOSING ALZHEIMER'S DISEASE
Abstract of WO2007128567
The invention relates to the use of metal complexes which contain at least one perfluorated alkyl group, at least one chelating agent group, and at least one metal ion equivalent of an element of atomic numbers 21-29, 31-33, 37-39, 42-44, 49 or 57-83, and salts thereof for producing a diagnostic agent for imaging amyloid-containing plaques.
Quelle: http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=WO2007128567&F…
EPIX Pharmaceuticals Makes a Significant Altzheimer's Discovery
posted on: December 23, 2007
EPIX Pharmaceuticals (EPIX) is a bio-pharmaceutical company that is focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient silico drug discovery platform. Last week, the company made a huge breakthrough relating to Alzheimer’s. As we all know some of the greatest inventions were stumbled upon accidentally. We all know about Ben Franklin, and what happened when chocolate met peanut butter - the rest is history.
It is just possible that what EPIX stumbled upon is extremely important to humanity.
The company initiated a phase 2A study of its Alzheimer’s disease drug, PRX-03140, to get safety and tolerability information. What happened? The company actually found that the drug had a profound impact on the Alzheimer’s Disease Assessment Scale cognitive subscale. While it usually takes drugs between 12 and 24 weeks to show an improvement, after only 2 weeks with PRX-03140, sufferers showed a marked improvement.
Even the CEO was surprised by the findings. Epix Chief Executive Officer Michael Kauffman said the company was surprised by the compound’s swift effectiveness.
“No drug has been shown to work this quickly, as far as we are aware,” said Kauffman, adding that other Alzheimer’s drugs generally must be taken for at least 12 weeks before any significant improvement can be observed.
With 5 million Americans Alzheimer’s the opportunity for EPIX is huge. It is also important to consider that with an aging population this could be absolutely huge for the little Biotech company with a market-cap of only $141 million.
After seeing the stock surge more than 50% on the news, it has fallen way back. With this potential revolutionary, blockbuster drug, this is a stock that should be trading much higher than the $4 range. For investors looking to take a swing at an up and coming drug company, EPIX is worth the look.
Quelle: http://seekingalpha.com/article/58205-epix-pharmaceuticals-m…
Schöne Weihnachtstage noch
Erbse
posted on: December 23, 2007
EPIX Pharmaceuticals (EPIX) is a bio-pharmaceutical company that is focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient silico drug discovery platform. Last week, the company made a huge breakthrough relating to Alzheimer’s. As we all know some of the greatest inventions were stumbled upon accidentally. We all know about Ben Franklin, and what happened when chocolate met peanut butter - the rest is history.
It is just possible that what EPIX stumbled upon is extremely important to humanity.
The company initiated a phase 2A study of its Alzheimer’s disease drug, PRX-03140, to get safety and tolerability information. What happened? The company actually found that the drug had a profound impact on the Alzheimer’s Disease Assessment Scale cognitive subscale. While it usually takes drugs between 12 and 24 weeks to show an improvement, after only 2 weeks with PRX-03140, sufferers showed a marked improvement.
Even the CEO was surprised by the findings. Epix Chief Executive Officer Michael Kauffman said the company was surprised by the compound’s swift effectiveness.
“No drug has been shown to work this quickly, as far as we are aware,” said Kauffman, adding that other Alzheimer’s drugs generally must be taken for at least 12 weeks before any significant improvement can be observed.
With 5 million Americans Alzheimer’s the opportunity for EPIX is huge. It is also important to consider that with an aging population this could be absolutely huge for the little Biotech company with a market-cap of only $141 million.
After seeing the stock surge more than 50% on the news, it has fallen way back. With this potential revolutionary, blockbuster drug, this is a stock that should be trading much higher than the $4 range. For investors looking to take a swing at an up and coming drug company, EPIX is worth the look.
Quelle: http://seekingalpha.com/article/58205-epix-pharmaceuticals-m…
Schöne Weihnachtstage noch
Erbse
Epix Factsheet Dezember 2007
PRX-00023 Ergebnisse werden im 1 Quartal 2008 erwartet.
PRX-00023 Ergebnisse werden im 1 Quartal 2008 erwartet.
Kurzer Kommentar des NeuroInvestor zur aktuellen Lage
From NI January 2008
PRX-00023, a 5HT-1a agonist, is in Phase IIb for depression, and data is expected this quarter. PRX-03140, a 5HT-4 agonist and optionable by GSK, recently reported PhIIa results. As noted on p.7, the fact that one 10pt cohort showed stunning improvement on the ADAS-cog after just 14 days, but not if Aricept was also given, makes us think it was a fluke, with huge variance, a small n, and poor trial design. PRX-07034, their 5HT-6 modulator originally intended as a cognitive upregulator for schizophrenia or Alzheimer's, had a good news/bad news experience: In Phase I it caused weight loss, adding obesity to its roster of possibilities. However, it also increased QTc intervals, which eliminated all of the possibilities for the parent molecule. Epix believes that they can achieve the same anti-obesity effects with an enantiomer. Positive data were also found in their COPD program, and GSK paid a milestone during 2007, reflective of progress in their GPCR alliance.
From NI January 2008
PRX-00023, a 5HT-1a agonist, is in Phase IIb for depression, and data is expected this quarter. PRX-03140, a 5HT-4 agonist and optionable by GSK, recently reported PhIIa results. As noted on p.7, the fact that one 10pt cohort showed stunning improvement on the ADAS-cog after just 14 days, but not if Aricept was also given, makes us think it was a fluke, with huge variance, a small n, and poor trial design. PRX-07034, their 5HT-6 modulator originally intended as a cognitive upregulator for schizophrenia or Alzheimer's, had a good news/bad news experience: In Phase I it caused weight loss, adding obesity to its roster of possibilities. However, it also increased QTc intervals, which eliminated all of the possibilities for the parent molecule. Epix believes that they can achieve the same anti-obesity effects with an enantiomer. Positive data were also found in their COPD program, and GSK paid a milestone during 2007, reflective of progress in their GPCR alliance.
EPIX Pharmaceuticals Announces Updated Results from Phase 2a Clinical Trial of PRX-03140 in Alzheimer's Disease
Data Continue to Show Statistically Significant Improvements in Cognitive Function and Favorable Safety Profile
EPIX, a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced revised results from its Phase 2a clinical trial of PRX-03140, its novel 5-HT4 agonist, in Alzheimer's disease. The trial was designed to assess the effects of PRX-03140 following two weeks of treatment as monotherapy and separately in combination with donepezil (Aricept(R)) in patients with mild Alzheimer's disease and the company announced initial findings on December 18, 2007. The updated results described below reflect the correction of previously undetected errors that were included in the trial results as provided to the company from a third party contract research organization (CRO) and as reported by the company in a recent press release, as well as newly available data on other measures of cognition.
As a result of errors made in the transcription of data and calculation of the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) score, an independent re-analysis of the data has been conducted. The corrected results show that patients receiving 150 mg of PRX-03140 orally once daily as monotherapy achieved a mean 3.6 point improvement on the ADAS-cog versus a 0.9 point worsening in patients on placebo, which continues to be statistically significant (p= 0.021). Data for the patients on a 50 mg dose of PRX-03140 showed a 1.0 point improvement on the ADAS-cog. The monotherapy dose response (150 mg versus 50 mg versus placebo) continues to be statistically significant with p=0.026. There were no substantive changes in the results from the combination arms of the study.
The previously reported safety results from the trial are unchanged. In the Phase 2a clinical trial, PRX-03140 appeared to be well tolerated, both alone and in combination with donepezil (Aricept(R)). No serious drug-related adverse events occurred during the trial.
The two-week study also utilized other cognitive tests including Mindstreams, an automated battery of computerized cognitive function tests. Patients on monotherapy demonstrated significant (pless than0.04) improvements in memory and visual-spatial indices as measured using Mindstreams when compared with placebo.
Based upon the compelling improvements in cognition demonstrated over such a short duration of time, EPIX has received requests from certain patients, caregivers and clinical trial investigators for continued access to PRX-03140. EPIX has been able to accommodate such requests on a case-by-case basis by extending the study to allow these patients to continue on PRX-03140. To date, one patient has completed 11 additional weeks of study treatment, and additional patients have initiated extended dosing.
"We are very excited by the measurable impact on memory and cognition achieved with PRX-03140 in a two-week study that was designed primarily to assess tolerability and safety. While we were disappointed that these errors were not detected during the CRO clinical monitoring or data verification processes, EPIX moved as quickly and efficiently as possible to reassess these data, reanalyze the findings and release the updated results of the trial to the public," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "With our partner, GlaxoSmithKline, we are continuing with our plans to initiate a Phase 2b clinical trial program in Alzheimer's patients in the first half of this year."
Data Continue to Show Statistically Significant Improvements in Cognitive Function and Favorable Safety Profile
EPIX, a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced revised results from its Phase 2a clinical trial of PRX-03140, its novel 5-HT4 agonist, in Alzheimer's disease. The trial was designed to assess the effects of PRX-03140 following two weeks of treatment as monotherapy and separately in combination with donepezil (Aricept(R)) in patients with mild Alzheimer's disease and the company announced initial findings on December 18, 2007. The updated results described below reflect the correction of previously undetected errors that were included in the trial results as provided to the company from a third party contract research organization (CRO) and as reported by the company in a recent press release, as well as newly available data on other measures of cognition.
As a result of errors made in the transcription of data and calculation of the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) score, an independent re-analysis of the data has been conducted. The corrected results show that patients receiving 150 mg of PRX-03140 orally once daily as monotherapy achieved a mean 3.6 point improvement on the ADAS-cog versus a 0.9 point worsening in patients on placebo, which continues to be statistically significant (p= 0.021). Data for the patients on a 50 mg dose of PRX-03140 showed a 1.0 point improvement on the ADAS-cog. The monotherapy dose response (150 mg versus 50 mg versus placebo) continues to be statistically significant with p=0.026. There were no substantive changes in the results from the combination arms of the study.
The previously reported safety results from the trial are unchanged. In the Phase 2a clinical trial, PRX-03140 appeared to be well tolerated, both alone and in combination with donepezil (Aricept(R)). No serious drug-related adverse events occurred during the trial.
The two-week study also utilized other cognitive tests including Mindstreams, an automated battery of computerized cognitive function tests. Patients on monotherapy demonstrated significant (pless than0.04) improvements in memory and visual-spatial indices as measured using Mindstreams when compared with placebo.
Based upon the compelling improvements in cognition demonstrated over such a short duration of time, EPIX has received requests from certain patients, caregivers and clinical trial investigators for continued access to PRX-03140. EPIX has been able to accommodate such requests on a case-by-case basis by extending the study to allow these patients to continue on PRX-03140. To date, one patient has completed 11 additional weeks of study treatment, and additional patients have initiated extended dosing.
"We are very excited by the measurable impact on memory and cognition achieved with PRX-03140 in a two-week study that was designed primarily to assess tolerability and safety. While we were disappointed that these errors were not detected during the CRO clinical monitoring or data verification processes, EPIX moved as quickly and efficiently as possible to reassess these data, reanalyze the findings and release the updated results of the trial to the public," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "With our partner, GlaxoSmithKline, we are continuing with our plans to initiate a Phase 2b clinical trial program in Alzheimer's patients in the first half of this year."
EPIX Pharmaceuticals Achieves $1.25 Million Milestone in Collaboration with Cystic Fibrosis Foundation Therapeutics
LEXINGTON, Mass.--(BUSINESS WIRE)--Jan. 23, 2008--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced that it has received a $1.25 million milestone payment from Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation. This milestone marks EPIX and CFFT's successful completion of the development of a validated model of a full-length Cystic Fibrosis Transmembrane conductance Regulator (CFTR) ion channel protein. A mutation in the CFTR gene that codes for this channel is one of the key factors that ultimately lead to the symptoms, complications and premature mortality in people with cystic fibrosis.
"Our collaboration with CFFT has now resulted in four achieved milestones in two years and further validates our computational-medicinal chemistry approach to drug discovery," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "Following the promising data from our Phase 2a clinical trial of PRX-03140, our novel drug candidate in Alzheimer's disease, we are pleased to begin 2008 with the continued success of our drug discovery engine and ongoing collaboration with our CFFT partners. This new, complete model of CFTR will allow us to prepare for the lead optimization process and further advance our research efforts in cystic fibrosis."
"This is a major milestone in our efforts to use structure-based technologies to design new drugs that could treat CF by addressing the basic defect," said Robert J. Beall, Ph.D., president and chief executive officer of the Cystic Fibrosis Foundation. "In the two years since this alliance was initiated, EPIX has been consistently ahead of schedule. Their full-length CFTR model was completed early, and has already been used to identify interesting molecules that increase CFTR activity in cell-based assays."
This is the fourth milestone payment under a research, development and commercialization agreement between EPIX and CFFT signed in 2005 that focuses on discovering potential drug therapies targeting the CFTR ion channel. The collaboration between the two organizations was recently expanded in November 2007 to allow EPIX to continue the discovery process, set up a biological lab and prepare for lead optimization.
"We continue to be pleased with the output of this successful collaboration and our ability to develop a validated model of the CFTR ion channel," said Hanoch Senderowitz, Ph.D., senior director, computational development of EPIX. "EPIX's proven discovery and drug development approach and our collaboration with CFFT have once again yielded key research advances and we look forward to continuing our joint efforts."
The most common mutations in the CFTR gene can impair the ability of the protein to be transported into the cell membrane and, therefore, to transport chloride out of cells. In the lungs and gastrointestinal tract, the reduced levels of CFTR in the membrane lead to the development of the abnormally thick, sticky mucous that causes chronic, life-threatening lung infections and impairs digestion in people with cystic fibrosis. EPIX is working with CFFT to discover drug candidates that can help restore proper functioning of the CFTR protein.
LEXINGTON, Mass.--(BUSINESS WIRE)--Jan. 23, 2008--EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, today announced that it has received a $1.25 million milestone payment from Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation. This milestone marks EPIX and CFFT's successful completion of the development of a validated model of a full-length Cystic Fibrosis Transmembrane conductance Regulator (CFTR) ion channel protein. A mutation in the CFTR gene that codes for this channel is one of the key factors that ultimately lead to the symptoms, complications and premature mortality in people with cystic fibrosis.
"Our collaboration with CFFT has now resulted in four achieved milestones in two years and further validates our computational-medicinal chemistry approach to drug discovery," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "Following the promising data from our Phase 2a clinical trial of PRX-03140, our novel drug candidate in Alzheimer's disease, we are pleased to begin 2008 with the continued success of our drug discovery engine and ongoing collaboration with our CFFT partners. This new, complete model of CFTR will allow us to prepare for the lead optimization process and further advance our research efforts in cystic fibrosis."
"This is a major milestone in our efforts to use structure-based technologies to design new drugs that could treat CF by addressing the basic defect," said Robert J. Beall, Ph.D., president and chief executive officer of the Cystic Fibrosis Foundation. "In the two years since this alliance was initiated, EPIX has been consistently ahead of schedule. Their full-length CFTR model was completed early, and has already been used to identify interesting molecules that increase CFTR activity in cell-based assays."
This is the fourth milestone payment under a research, development and commercialization agreement between EPIX and CFFT signed in 2005 that focuses on discovering potential drug therapies targeting the CFTR ion channel. The collaboration between the two organizations was recently expanded in November 2007 to allow EPIX to continue the discovery process, set up a biological lab and prepare for lead optimization.
"We continue to be pleased with the output of this successful collaboration and our ability to develop a validated model of the CFTR ion channel," said Hanoch Senderowitz, Ph.D., senior director, computational development of EPIX. "EPIX's proven discovery and drug development approach and our collaboration with CFFT have once again yielded key research advances and we look forward to continuing our joint efforts."
The most common mutations in the CFTR gene can impair the ability of the protein to be transported into the cell membrane and, therefore, to transport chloride out of cells. In the lungs and gastrointestinal tract, the reduced levels of CFTR in the membrane lead to the development of the abnormally thick, sticky mucous that causes chronic, life-threatening lung infections and impairs digestion in people with cystic fibrosis. EPIX is working with CFFT to discover drug candidates that can help restore proper functioning of the CFTR protein.
EPIX Pharmaceuticals Reaches Agreement with FDA on Protocol, Initiates Re-Read of Vasovist(TM) Phase 3 Images
LEXINGTON, Mass.--(BUSINESS WIRE)--Jan. 31, 2008--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist(TM) (gadofosveset trisodium). EPIX has received an Action Letter from the FDA confirming that the jointly agreed-upon protocol design and statistical analysis plan adequately address the objectives necessary to support the resubmission of the New Drug Application (NDA) for Vasovist. EPIX has initiated the re-read of images obtained in prior Phase 3 studies. Vasovist has been approved for marketing in 33 countries outside of the U.S.
"We are extremely pleased with the progress we have made with the FDA," said Andrew Uprichard, M.D., Ph.D., president and head of research and development at EPIX. "We have designed a protocol with input from the FDA that outlines the methodology of conducting the re-read of images and the statistical analysis of the data. As we announced in June 2007, the FDA has indicated that a blinded re-read of the images obtained from the previously completed Phase 3 clinical trials of Vasovist could support approval if the results meet the pre-specified endpoints agreed with the Agency. We expect to submit these results in mid 2008."
About Vasovist(TM)
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography imaging (MRA). The initial target indication for Vasovist is for use in MRA imaging of the non-coronary vascular system. Vasovist has been approved for marketing in 33 countries, including among others all 27 member states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are part of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including among others Germany, the Netherlands, Italy, all Nordic countries, United Kingdom, and Switzerland.
LEXINGTON, Mass.--(BUSINESS WIRE)--Jan. 31, 2008--EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on its proposal for the re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist(TM) (gadofosveset trisodium). EPIX has received an Action Letter from the FDA confirming that the jointly agreed-upon protocol design and statistical analysis plan adequately address the objectives necessary to support the resubmission of the New Drug Application (NDA) for Vasovist. EPIX has initiated the re-read of images obtained in prior Phase 3 studies. Vasovist has been approved for marketing in 33 countries outside of the U.S.
"We are extremely pleased with the progress we have made with the FDA," said Andrew Uprichard, M.D., Ph.D., president and head of research and development at EPIX. "We have designed a protocol with input from the FDA that outlines the methodology of conducting the re-read of images and the statistical analysis of the data. As we announced in June 2007, the FDA has indicated that a blinded re-read of the images obtained from the previously completed Phase 3 clinical trials of Vasovist could support approval if the results meet the pre-specified endpoints agreed with the Agency. We expect to submit these results in mid 2008."
About Vasovist(TM)
Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography imaging (MRA). The initial target indication for Vasovist is for use in MRA imaging of the non-coronary vascular system. Vasovist has been approved for marketing in 33 countries, including among others all 27 member states of the European Union, Switzerland, Turkey, Australia and Canada. The marketing rights to Vasovist are held by Bayer Schering Pharma in Europe and by Bayer HealthCare Pharmaceuticals in the United States and Canada. Both companies are part of Bayer AG. Vasovist is currently marketed in Canada and 18 European countries, including among others Germany, the Netherlands, Italy, all Nordic countries, United Kingdom, and Switzerland.
Kurzer Kommentar des NeuroInvestor zu den PRX-03140 Daten aus der Februar Ausgabe.
In einigen Tagen sollten die PRX-00023 Ergebnisse zu den Depression Phase 2b Versuchen veröffentlicht werden. War zumindest so angekündigt.
EPIX Pharmaceuticals
From NI February 2008
Epix's Epic Embarrassment: "Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX Pharmaceuticals stated, “We are very excited by the measurable impact on memory and cognition, achieved in such a short period of time, in a trial that was designed primarily to assess safety and tolerability."
--Press release from Epix Pharmaceuticals, 12/18/07
"When things seem to be too good to be true, they usually are (too good to be true): Epix's Alzheimer's trial for its 5HT-4 drug PRX-03140 showed an amazing 5.7 point ADAS-cog improvement in just two weeks...albeit in just one 10 patient dose cohort, with two 14 point responders, the mean change for the others was 3.3 points, and the other six cohorts did not show significant benefit. And there was no benefit if the patients also received Aricept--Epix states that these patients hadn't been washed out, and thus were already at the cholinergic ceiling (dubious trial design and execution). But other than that, these were revolutionary results. So revolutionary, in fact, that NI strongly doubts that they will be replicated. Because they are not only revolutionary, they make no sense."
--NeuroInvestment 1/06/08
"The updated results described below reflect the correction of previously undetected errors that were included in the trial results as provided to the company from a third party contract research organization (CRO) and as reported by the company in a recent press release, as well as newly available data on other measures of cognition.
As a result of errors made in the transcription of data and calculation of the Alzheimer’s Disease Assessment Scale cognitive subscale (ADAS-cog) score, an independent re-analysis of the data has been conducted. The corrected results show that patients receiving 150 mg of PRX-03140 orally once daily as monotherapy achieved a mean 3.6 point improvement on the ADAS-cog versus a 0.9 point worsening in patients on placebo, which continues to be statistically significant (p= 0.021).
--Press release from Epix Pharmaceuticals, 1/15/08
"Oh. That's very different. Never mind."
--Gilda Radner 1976
Perhaps in the future, if circumstances warrant, Epix will conduct the "independent re-analysis' of suspect data before broadcasting them.
In einigen Tagen sollten die PRX-00023 Ergebnisse zu den Depression Phase 2b Versuchen veröffentlicht werden. War zumindest so angekündigt.
EPIX Pharmaceuticals
From NI February 2008
Epix's Epic Embarrassment: "Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX Pharmaceuticals stated, “We are very excited by the measurable impact on memory and cognition, achieved in such a short period of time, in a trial that was designed primarily to assess safety and tolerability."
--Press release from Epix Pharmaceuticals, 12/18/07
"When things seem to be too good to be true, they usually are (too good to be true): Epix's Alzheimer's trial for its 5HT-4 drug PRX-03140 showed an amazing 5.7 point ADAS-cog improvement in just two weeks...albeit in just one 10 patient dose cohort, with two 14 point responders, the mean change for the others was 3.3 points, and the other six cohorts did not show significant benefit. And there was no benefit if the patients also received Aricept--Epix states that these patients hadn't been washed out, and thus were already at the cholinergic ceiling (dubious trial design and execution). But other than that, these were revolutionary results. So revolutionary, in fact, that NI strongly doubts that they will be replicated. Because they are not only revolutionary, they make no sense."
--NeuroInvestment 1/06/08
"The updated results described below reflect the correction of previously undetected errors that were included in the trial results as provided to the company from a third party contract research organization (CRO) and as reported by the company in a recent press release, as well as newly available data on other measures of cognition.
As a result of errors made in the transcription of data and calculation of the Alzheimer’s Disease Assessment Scale cognitive subscale (ADAS-cog) score, an independent re-analysis of the data has been conducted. The corrected results show that patients receiving 150 mg of PRX-03140 orally once daily as monotherapy achieved a mean 3.6 point improvement on the ADAS-cog versus a 0.9 point worsening in patients on placebo, which continues to be statistically significant (p= 0.021).
--Press release from Epix Pharmaceuticals, 1/15/08
"Oh. That's very different. Never mind."
--Gilda Radner 1976
Perhaps in the future, if circumstances warrant, Epix will conduct the "independent re-analysis' of suspect data before broadcasting them.
Epix Halts Clinical Drug Development
Thursday March 20, 8:43 am ET
Epix Pharmaceuticals Stops Clinical Development of Drug to Treat Major Depressive Disorder
LEXINGTON, Mass. (AP) -- Epix Pharmaceuticals Inc. said Thursday it will stop clinical development of a drug candidate in patients who have major depressive disorder.
The biopharmaceutical company plans to stop clinical development of PRX-00023 because the drug was not significantly effective in a mid-stage trial in patients with major depressive disorder, also known as clinical depression.
According to the National Institute of Mental Health, major depressive disorder is characterized by a number of symptoms, including the inability to work, eat and sleep.
Separately, Epix will begin a right-heart catheter study by mid-2008 for drug candidate PRX-08066 in patients who have pulmonary hypertension from chronic obstructive pulmonary disease.
Pulmonary hypertension is characterized by high blood pressure in the pulmonary artery that can obstruct airflow and interfere with normal breathing.
Shares of Epix tumbled 58 cents, or 18.8 percent, to $2.50 in Thursday premarket trading, after ending at $3.08 on Wednesday.
Thursday March 20, 8:43 am ET
Epix Pharmaceuticals Stops Clinical Development of Drug to Treat Major Depressive Disorder
LEXINGTON, Mass. (AP) -- Epix Pharmaceuticals Inc. said Thursday it will stop clinical development of a drug candidate in patients who have major depressive disorder.
The biopharmaceutical company plans to stop clinical development of PRX-00023 because the drug was not significantly effective in a mid-stage trial in patients with major depressive disorder, also known as clinical depression.
According to the National Institute of Mental Health, major depressive disorder is characterized by a number of symptoms, including the inability to work, eat and sleep.
Separately, Epix will begin a right-heart catheter study by mid-2008 for drug candidate PRX-08066 in patients who have pulmonary hypertension from chronic obstructive pulmonary disease.
Pulmonary hypertension is characterized by high blood pressure in the pulmonary artery that can obstruct airflow and interfere with normal breathing.
Shares of Epix tumbled 58 cents, or 18.8 percent, to $2.50 in Thursday premarket trading, after ending at $3.08 on Wednesday.
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