BioProtein + Plus TM Proof of Concept – Open Label Pilot Study

Summary - Thirty-five people, each symptomatic and clinically positive for Hepatitis C infection, and displaying
elevated AST & ALT Liver enzymes and RNA PCR Viral counts, were tested at regular intervals over a six month
period, to determine any changes in these values, while taking one packet of BioProtein+Plus TM per day. Other
inclusion criteria were: no significant co-infection and no other current treatment for Hepatitis C was permitted or
given. Of the thirty-five people enrolled, twenty-seven completed the trial and the data gathered was statistically
analyzed. Twenty-five of the participants reported significantly increased energy levels and a much-improved
feeling of overall wellness. Five participants demonstrated no clinical improvement.

Overall the study results were highly significant and the p-value indicates that the results were not due to chance
alone or due to experimental effects.

Introduction - Hepatitis C has an incubation period of 15 to 150 days before the onset of clinical symptoms. Early
symptoms are commonly fatigue and jaundice. The majority of cases, even those that develop chronic infection, are
asymptomatic. In 60 to 70 percent of infections, 10 to 20 years may pass between infection and the onset of
symptoms. Once symptomatic, the virus can cause deterioration of liver function, cirrhosis, and liver cancer and may
be a pathway for opportunistic co-infection. There are perhaps 3-4 million people diagnosed with Hepatitis C in the
United States and maybe that many more not yet diagnosed because of the long latency period. World wide it is
estimated that as many as 170 million people are infected.

Antiviral drugs are available for treatment. People with chronic Hepatitis C can use interferon taken alone or in
combination with Ribavirin. Ribavirin does not appear to be effective alone, Interferon by itself, is about 10 to 20
percent effective, and in combination with Ribavirin, it is effective in 30 to 50 percent of cases.

BioProtein+Plus TM is a unique nutritional supplement containing biologically active thymic proteins ranging in
atomic weight from 10,000 to 50,000 Daltons, plus zinc gluconate. Thymic proteins have been shown to stimulate
mature lymphocytes and enhance a cell mediated, highly specific immune response to virus. The proteins contained
in BioProtein+Plus TM are purified from calf thymus and triturated with the zinc gluconate into a base of
Maltodextrin, then sealed in packets containing approximately 400 mg. of product. BioProtein+Plus TM is available
over the counter in boxes of 30 packets and is taken one packet per day, or as recommended by a health care
practitioner.

RNA PCR measurements are commonly used to diagnose Hepatitis C, and elevated ALT and AST liver enzymes are
common symptoms of active Hepatitis C infection. The purpose of the study was to determine if BioProtein+Plus TM
has biological activity by demonstrating a cell mediated immune response as measured by a reduction in RNA PCR
and concurrent reductions in ALT and AST levels in Hepatitis C infected people.

Methods - This study was conducted as a Proof of Concept- Open Label Pilot Study only. Thirty-five people
meeting the inclusion criteria were recruited from the customer base of BioActive Research, the manufacturers of
BioProtein+Plus TM to participate in the study for six months. Each volunteer was supplied enough product to take
one packet per day at no cost. Each participant was required to obtain a baseline, 3 month and 6 month blood test
measuring AST, ALT and RNA PCR from their regular health care provider. The blood test results were transmitted
to BioActive Research for compilation and statistical analysis. AST and ALT levels were tested before treatment
and at 3 and 6-month intervals, RNA PCR levels were measured before treatment and at 6 months.

The participants were not otherwise monitored and were requested to forego any other Hepatitis C treatment during
the six-month study period.

Results - Of the thirty-five participants enrolled, twenty-seven completed the study. No one reported any adverse
side effects. The accompanying table and graphs illustrate the statistical significance of the reductions in AST, ALT
and RNA PCR. Although this was a non-blinded pilot study, the purpose of the exercise was to demonstrate that
BioProtein+Plus TM is a biologically active product that can stimulate cell mediated immunity. The accompanying
analysis indicates highly statistically significant reductions in serological categories with 99 % likelihood that the
results were achieved by the treatment and not by chance or due to experimental effects.

BioActive Research
 BioProtein + Plus TM Proof of Concept – Open Label Pilot Study

AST 3 mo. 6 mo. ALT 3 mo. 6 mo. RNA PCR 6 mo.

Mean 83 57.888 44.148 108.222 74.529 56.407 38763 23200

Ste. Dev. 23.42 32.543 24.013 29.855 30.648 34.855 21.193 23677

Differences from Baseline Conditions, df=26

Mean -25.111 -38.851 -33.629 -51.815 -15562
Std. Dev. 19.721 16.256 21.294 26.76 12143
Std. Err. 3.795 3.128 4.098 5.149 2337
T= -6.61609 -12.418 -8.2059 -10.061 -6.659
P< 2.56E-07 9.97E-13 5.47E-09 9E-11 2.298E-07

99 % Confidence Intervals for the Mean

Low -34.877 -46.91 -44.185 -65.08 -21582
High -15.334 -30.793 -23.073 -38.55 -9542

Mean IU/L Over Time Individual AST IU/L

Over Time
120
SGOT (AST) IU/L

100 200
80
IU/L

60 150
40 100
20 50
0 0
Initial 3 Months 6 Months Initial 3 6
Months Months
SGOT (AST) SGOT (ALT)

Individual ALT IU/L Individual RNA PCR

Over Time Quantity Over Time

200 120000
RNA PCR Quantity
SGOT (ALT) IU/L

100000
150
80000
100 60000
40000
50
20000
0 0
Initial 3 Months 6 Months Initial 6 Months

All Participants

BioActive Research
 BioProtein + Plus TM Proof of Concept – Open Label Pilot Study

References
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2. Kouttab NM, Prada M., Cazzola P. Thymomodulim. Biological properties and clinical applications. Med
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3. Cazzola P, Mazzanti P, Bossi G. In vivo modulation effect of a calf thymus acid lysate on human T
Lymphocyte subsets and CD4+/CD8+ ratio in the course of different diseases. Curr Ther Res 1987; 42:
1011-1017.
4. Eaterbrook-Smith S. Activation of the binding of C1q to immune complexes by zinc. FEBS Lett 1983; 162:
117-119.
5. Hadden JW. The treatment of zinc deficiency in immunotherapy. Int J Immunopharmac 1995; 17: 697-
701.

BioActive Research