Thanks,Mach. What do you think about XKEM?
The Press release below talks about their clinical trial results for sickle cell anemia,,,and thos results are about ot be published in a Medical Journal (June Issue)
May explain a few things.
Xechem Presents Update on NIPRISAN -- Nix-0699 at Annual Meeting of the National Sickle Cell Disease Program; Projects Filing IND Before Year End
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--April 27, 2004--On April 20, 2004, Xechem International, Inc. (OTC BB:XKEM) and Dr. Peter N. Gillette, a Sickle Cell Disease Clinician from the State University of New York (SUNY) at Brooklyn co-presented their latest results in the ongoing evaluation of NIPRISAN (new names NICOSAN(TM)/HEMOXIN(TM)) through in-vitro and in-vivo analyses. The information was presented at the 27th Annual Meeting of the National Sickle Cell Disease Program: Therapy for Sickle Cell Disease: Making Promise a Realty this past week in Los Angeles, CA.
Dr. Gillette reported results of Nigerian toxicity studies in animals which demonstrated LD50 (dose at 50% animal death) of 2000-5000 mg per kg of animal weight. This is an unusually safe margin since the early human studies were at 12-15 mg per kg. Additional pharmacologic studies showed no significant organ damage.
Additional findings from the clinical studies performed in Nigeria and work done at Xechem suggest that twice daily administration could be more effective and that higher doses might be well tolerated. Additional dose escalation and schedules are being planned for Phase III clinical trials in Nigeria. To date, Phase I and Phase II clinical studies in Nigeria suggest that NIPRISAN appears to be an efficacious anti-sickling drug, well tolerated, and toxicity, thus far, is acceptable.
Xechem cited significant progress during the last six months through ongoing research in the quality control and standardization of NIPRISAN as a phyto-pharmaceutical. According to Dr. Ramesh C. Pandey, Chairman & CEO of Xechem International, Inc., these studies are close to completion. Dr. Pandey believes upon successful completion of the standardization research, Xechem will be in a position to file its Investigational New Drug ("IND") application to FDA for HEMOXIN(TM), already under Orphan Drug designation by year end.
On Sept. 2, 2003, Xechem International, Inc. ("Xechem") announced that it received Orphan Drug designation from the U.S. Food and Drug Administration ("FDA"), Office of Orphan Drug Products Development for NIPRISAN, under the name HEMOXIN(TM), as a phyto-pharmaceutical drug for the treatment of patients suffering with Sickle Cell Disease ("SCD").
According to a study published by Allison Ashley-Koch, Quanhe Yang, and Richard S. Olney of the Centers for Disease Control and Prevention ("CDC"), Sickle Cell Disease is a major public health concern. Each year in the US, an average of 75,000 hospitalizations are due to Sickle Cell Disease, costing approximately $475 million. The average length of stay per hospital visit was 6.1 days and adults tended to have longer stays than children and adolescents.
AI
