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Clinical Trials

The lead clinical investigator of Alphamir and Arthromir is Davy Kiprotich Koech. For the past 19 years, Dr. Koech has served as chief research officer and chief executive of KEMRI. He is the author of 161 refereed journal publications in the fields of HIV/AIDS, malaria, leishnamiasis, schistosomiasis and numerous other diseases. He holds three doctorate degrees and is a member of numerous national and international medical organizations.

 

      Clinical Trials
      Diseases
      Conclusions
 

Under Dr. Koech's direction and supervision, research physicians conducted anecdotal Phase 1 and Phase 2 HIV/AIDS and rheumatoid arthritis studies at KEMRI on a total of 176 patients. The Phase 1 double-blind trial involved 30 patients – three arms of 10 patients each – with oropharyngeal, suppository and control testing for AIDS. The immunological results showed 100+% increased CD4 lymphocytes levels in groups treated with Alphamir versus zero change for the control group. The Phase 2 open label clinical tria,l with randomized doses for efficacy, safety and tolerability was conducted with 43 patients. Results showed consistent and steady weight gain and half the patients achieved significant increases in CD4 levels with one-third reduction in viral load. Patient follow-up continues with monthly viral-load testing and no adverse effects found.

In October 2007, BioChem Solutions announced a continuing alliance with Molecular Technologies and KEMRI to initiate Phase 3 clinical trials. The third-phase studies gather more information about safety and efficacy, studying different populations and different dosages as well as observing the consequences of using the drugs in combination with other pharmaceuticals. The number of study subjects usually ranges from several hundred to several thousand persons.

Phase 3 clinical trials commence when evidence of product effectiveness is shown in Phase 2 trials, as been the achieved result for both our Alphamir and Arthromir drugs.
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