BACKGROUND: Alpha peptide, the FC portion of Shark IgG has been identified as the main peptide responsible for antiviral and antineoplastic activity in mice. The synthetic alpha peptide has been evaluated in animal studies and found to have the same antitumor, antiviral activity with no toxicity. In normal human volunteers at doses three times higher than those used for this clinical trial alpha peptide elicited no adverse effects.

OBJECTIVE: To evaluate the efficacy and safety of oral and intravenous alpha peptide in 40 terminal cancer patients.

DESIGN: This study was conducted as an open pilot clinical trial. Patients fulfilling inclusion criteria and in the absence of exclusion criteria, signed a informed consent to receive oral alpha peptide 600 ug per day or intravenous alpha peptide 10 mg three times a week over a twelve week period.

RESULTS: 44 terminal cancer patients with diverse oncological disease were entered into the study. Patient distribution were: 56 percent women, 44 percent men ranging from 15 to 87 years old: 59+/- 12. Four patient were dropped from the study (6.8%), but considered as "intent to treat", thus assessed for safety. 25% died during the trial, 29.5% became worse and 38.6% were considered as responders to treatment as determined by tumor response and improvement of the Karnofsky index. Adverse effects associated with alpha peptide were mild and were present with the oral administration and consisted of gastrointestinal disturbances.

CONCLUSION: This pilot clinical trial provides evidence to continue further research in the beneficial effects of alpha peptide in the treatment of cancer.