Curr Opin Invest Dr
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Pfizer is developing pregabalin, a follow-up compound to its GABA agonist gabapentin, for the potential treatment of several central nervous system (CNS) disorders including epilepsy, neuropathic pain, anxiety and social phobia [286425]. By December 2000, Pfizer anticipated filing an NDA for pregabalin for seven major indications (beginning with neuropathic pain and add-on epilepsy), with the FDA by the end of 2001. ⋯ However, following analysis by the FDA of a mouse study that showed incidence of a specific tumor type, Pfizer announced in February 2001, that it is restricting the use of pregablin in some clinical patients [398726] and it has frozen trials for neuropathic pain [398785]. In April 2001, Morgan Stanley Dean Witter predicted potential sales of $350 million in 2002, rising to $1750 million in 2006, with peak sales in excess of $2000 million [406923].
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Recent advances have dramatically increased our understanding of cannabinoid pharmacology: the psychoactive constituents of Cannabis sativa have been isolated, synthetic cannabinoids described and an endocannabinoid system identified, together with its component receptors, ligands and their biochemistry. Strong laboratory evidence now underwrites anecdotal claims of cannabinoid analgesia in inflammatory and neuropathic pain. Sites of analgesic action have been identified in brain, spinal cord and the periphery, with the latter two presenting attractive targets for divorcing the analgesic and psychotrophic effects of cannabinoids. Clinical trials are now required, but are hindered by a paucity of cannabinoids of suitable bioavailability and therapeutic ratio.
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Pharmacyclics is developing Gd-Tex (gadolinium texaphyrin) as a radiosensitizer for the potential treatment of various cancers including brain metastases and primary brain tumors, pancreatic tumors, lung tumors and pediatric cancers [196711], [348919]. The compound entered phase III pivotal trials for brain metastases in September 1998 [323929]. Phase I clinical trials for the treatment of primary brain tumors and pancreatic cancer have been initiated while several trials in other cancer types are in the planning stages [367716]. ⋯ Two phase I trials of Gd-Tex for the treatment of primary brain tumors commenced in August 1998 under a CRADA with the NCI [237538], [295592], [348919]. Pharmacyclics is collaborating with the NCI under a CRADA in phase I trials in primary brain tumors and pancreatic tumors [323929], [323952], [346596]. Analysts expected a filing to occur by the end of 1999 or early 2000, with sales in 2001 [303186].
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Cell Pathways has developed exisulind (Aptosyn), an oral apoptosis modulator and cGMP phosphodiesterase inhibitor, for the potential treatment of several oncologic indications including precancerous adenomatous polyposis coli (APC), also known as familial adenomatous polyposis (FAP), precancerous sporadic colonic polyps, cervical dysplasia and the prevention of tumor recurrence in prostate and breast cancer. An NDA filing for the treatment of precancerous APC, for which the US FDA designated exisulind a Fast Track product in July 1998, was initially expected in March 1999 [291313]. However, in January of the same year the company stated that it anticipated a delay in the NDA filing. ⋯ Also in July 2000, Cell Pathways announced that patents covering methods of identifying compounds that selectively stimulate apoptosis have been allowed in Europe and Japan. The patents describe the mechanism of action of Cell Pathways' SAANDs, including exisulind, and use of that knowledge in screening for new drugs [374888]. In January 1999, the company received US-05858694 covering the mechanism of action of exisulind [311504].