Fox, more evidence that the attitude towards DMSO is changing. While Pharma 21's efforts don't constitute approval it shows a change in FDA mindset towards DMSO...
pharma21.net
(Excerpt)...
"Summary of PHA-52 pre-clinical studies
Dimethyl sulfoxide (PHA-52) has been shown to be a powerful free radical scavenger 30-34 with antiinflammatory and cell membrane stabilizing activity. 35-37
Dimethyl sulfoxide has also been shown to lower brain edema in animal models including rhesus monkeys, and in humans.26,27, 38-40 Dimethyl sulfoxide has the ability to increase cerebral blood flow (CBF) following a variety of cerebral insults, possibly as a result of reducing tissue edema and lowering cerebrovascular resistance.21-23, 33,39 DMSO has been reported to improve neurologic and functional outcome after induced brain ischemia in animals, including non-human primates.41-46
In addition, dimethyl sulfoxide has been shown to be a sodium channel blocker. 28,29 Drugs that block voltage-dependent Na+ channels have been shown to exhibit strong, neuroprotective activity in animal models of brain ischemia/hypoxia and a number of clinical trials are now in progress to test these class of drugs when cerebral ischemia is present. 47-50 The Na+ channel blocking activity by dimethyl sulfoxide,28,29 could in part explain its beneficial effect when administered to patients presenting with high ICP secondary to severe, closed head injuries 26,27 or in the presence of cerebral bleeding resulting in clinically elevated ICP.22"
Later...(emphasis added)
Present status of PHA-52
PHA-52 is presently ready for human trials in the treatment of severe head injury. Pharma 21 has been granted an IND (investigational new drug, NR 39,262) by the FDA and Orphan Drug Product status (NR 94-813) giving the Company exclusive marketing rights for seven years after PHA-52 reaches the market. Company anticipates "fast-track" review by the FDA since PHA-52 is aimed at a "life threatening" injury. Fast track review also means that PHA-52 could be approved for marketing after phase II testing instead of the customary phase III requirement by the FDA. This could result in substantial Company savings in time and money and could result in an earlier generation of revenues to the Company.
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[Edit: The fast-track info was bolded for its potential relevance to WF10]
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The combination of extensive prior basic research, prior human studies, prior FDA approval of the active ingredient in PHA-52 (for interstitial cystitis), and the absence of another effective treatment for head injury, leads the Company to reasonably anticipate that PHA-52 will enter clinical trials at the end of the safety testing stage (phase I) or at the beginning of the safety and effectiveness testing stage (phase II)."
pharma21.net
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Therapeutic uses of DMSO from Pharma 21...
pharma21.net
pharma21.net
pharma21.net
Jim |
