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Journal of Pharmacology and Toxicology
  Year: 2010 | Volume: 5 | Issue: 3 | Page No.: 91-97
DOI: 10.3923/jpt.2010.91.97
Dose Escalation Phase I Study in Healthy Volunteers to Evaluate the Safety of a Natural Product PM701
F. Khorshid, H. Alshazly, A. Al Jefery and Abdel-Moneim M. Osman

Abstract:
Drug discover from natural sources has played an important role in the treatment of cancer and indeed, most new clinical applications of natural materials over the last half century have been applied to combating cancer. Therefore, this study was directed to describe the safety observations following oral administration of an active ingredient PM701 separated from the camel urine which is a clean, sterile product with antiproliferative activity in experimental tumor bearing animals. The study included 14 healthy volunteers with age between 21-48 years (male and female). They were subjected to full history taking, clinical examination and full laboratory tests including liver and kidney functions hematological parameters (Hb, WBCs and platelet count).The same test were done after oral administration of capsules containing PM701. This fraction has been formulated in gelatin capsule containing 300 mg capsule-1. Systemic reactions of normal volunteers after oral administration of capsules containing PM 701over 28 days revealed no adverse effects on the vital organs. Liver and kidney functions showed no abnormalities. Also, complete blood picture revealed normal pattern before and after PM701 treatment. Two patients only developed hyperacidity which was easily been treated. We may conclude that the product MP701 is safe and may be ready to move to the phase II trials on people who all have the same type of cancer or with several different types of cancer aiming to detect which types of cancer PM701 works for and to get more knowledge about side effects and how to manage them.
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COMMENTS
21 October, 2012
Loton:
This scientifically proven medical efficacy of camel urine amply witnessed for the much-attacked Islamic prophetic saying or prescription. What the world needs is cure, not polemics, from anywhere it comes.
 
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