OA PATIENTS

During the initial phase of the RA trial, several patients with OA asked to be included, because of the excellent results they saw on their friends or relatives. Since the Infopeptides had initially shown to be very effective in pain control regardless of cause, and because of its general safety and tolerance, we decided to initiate a parallel observation including OA patients.

10 patients, all female, (average age 58.4 years) entered the observation. Duration of disease ranged from 6 months to 11 years, averaging 5.6 years. All patients were on a NSAID, and 2 had other medications when they entered the trial.

OA patients were evaluated based on patient estimated scale of pain, where 0 would be total absence of pain, and 100 the worst pain.

9 out of 10 patients reported a significant reduction of pain, and showed clinical reduction of inflammation, between 15 and 21 days after starting the therapy. The average response time was 16 days. After the initial three-month evaluation period, only 5 patients were taking NSAID's while the others were taking the Infopeptides as their only therapy. The only patient who did not report pain reduction of relief despite showing a clinically significant reduction of local edema and heat, had severe, deforming knew damage, where surgery was indicated.

COMMENTS

After the initial step, we concluded this colostrum product contains one or more immunomodulating agents that promote antiinflammatory cytokine-type activity resembling the antiinflammatory activity of Cytokines 4, 10, 13, 15, 16. Longer follow-up and laboratory support data will be necessary to determine whether or not it is possible to stop, or even revert to any extent the existent articular cartilage damage (this effect was described in vitro using Cytokines 4 and 10 on mononuclear cells of RA patients) (40).

As expected from Biologic Response modulator, the effects of the Infopeptides are not disease-specific, allowing the organism to recuperate normal functioning patterns, regardless of the original immune system disease process. This hypothesis is supported by the good responses observed in both RA and OA. At present time, there are several other autoimmune processes that are already receiving benefit from this therapeutic alternative, with promising results.

The results of this initial clinical trial are very significant, not because of the high level of clinical response of the whole group of patients, but also because of the sustained benefit and improvement on prolonged therapy. Its oral administration, low cost when compared to other current experimental biologic response modulators, and the absence of side effects are remarkable as well. Nevertheless, to us, as clinicians, the most valuable aspect of this new therapeutic alternative is its almost miraculous effect on pain relief....something humanity has always longed for.