CLINICAL TRIALS ESTABLISHING MAC/98alive™ AS AN INFLUENZA TREATMENT

All clinical trial data and reports referred to in this section are available in full upon request.

Test 1: AMS Laboratories Study on Virucidal Properties of MAC on H5N1 Influenza Virus

Study conducted by AMS Laboratories (NSW, Australia) to determine the virucidal potential of MEGABACTM (a previous development name for MAC/ 98aliveTM) against the influenza type ‘A’ virus. The test strain used was FM/1/47/A/H5N1.

MEGABACTM /98alive™ concentrations of 0.5% and 0.25% concentrations were tested at contact times of ten and sixty minutes.

Study concluded that MEGABACTM “was able to kill the influenza ‘A’ virus at room temperature with contact times of ten to sixty minute s in a surface carrier test model. The extent of virus killed ranged between 3.4 and 5.0 logs with greater effect seen at the 0.5% concentration”. There did not appear to be a time related increase in virus kill, suggesting that MAC/98alive™ will work with the same speed of bio-availability as evidenced in the clinical trials for the treatment of Dengue (see Dengue verification)

Test 2: CSIRO Livestock Study on Efficacy of MegaBacTM /98alive™ in inactivating the H5N1 Avian Influenza Virus

Study conducted by CSIRO Livestock Industries’ Australian Animal Health Laboratory in Geelong, Victoria to determine the efficacy of MEGABACTM (a previous name for 98aliveTM) at inactivating the A/H5N1 Avian Flu virus.

The study found that MEGABACTM could deactivate (i.e. kill) between [47] % and [85] % of the A/H5N1 subtype depending on concentration and contact time. 100% virus kill was achieved within 4 hours contact time by MEGABACTM at 4% concentration.

Analysis of killed virus cells by electron microscope indicated that the surface membrane of the virus had changed after treatment with MEGABACTM. MEGABACTM affected the viability of each virus cell.

Table XI

98alive™ concentration 60 Minutes 120 Minutes 240 Minutes
2% 4.1 4.5 3.1
3% 2.9 3.5 2.9
4% 3.1 2.7 0
Untreated virus 7.1    
Mock-treated virus 7.5    

Log 10 residual virus titre after MAC/98alive treatment in (EID50/0.1 ml)

Solutions were prepared for negative contrast electron microscopy as per the protocol described in the QA manual. All samples were imaged with a Philips M120 at 100kK and recorded with a MegaView III digital camera.

Sun Yat-sen University/Griffiths University Study into Virucidal Properties of MAC/98alive™ on H1N1 Influenza Virus

The study was conducted to investigate the virucidal properties of MAC/98alive™ against human influenza type A virus (the strain tested was A/H1N1, commonly known as Swine Flu) in vitro and toxicity of various strength doses of MAC (concentrations of 0.1%, 0.05% and 0.025%). The study utilised MDCK cells as the test host.

Toxicity tests indicated that MAC/98aliveTM was not toxic to the MDCK cells at concentrations of 0.25% and lower.

The study concluded that MAC/98aliveTM demonstrated significant virucidal activity against the H1N1 strain, achieving over 70% reductions in the incidence of viral infection of the host cells within four hours as compared to the untreated control group.

The study further concluded that the “inhibition activity of MAC against the influenza virus strains would…” have “…a significant advantage over other strain specific antiviral drugs because of the lack of emergence of resistant viruses to all the components of MAC”.

Figure 2: MAC/98alive™: H5N1 + Treatment

Image showing numerous virus particles following treatment; the surface membrane (envelope – orange arrow) is no longer homogenous and surface projections are largely missing (blue arrows).
M.A.C. Efficacy
Upon treatment of H5N1 with 4% MAC/ 98alive™ for three hours, the ultrastructure of the virus changes;

Positive control samples displayed ultrastructure consistent with that described for viruses belonging to the family Orthomyxoviridae.

(Virus taxonomy: Eighth Report of the International Committee on Taxonomy of Viruses. Edited by C.M. Rauqet, M.A. Mayo, J. Manilooff, U. Desselberger, and L.A. Ball – Elsevier, Academic Press 2005, p681-693).

The ultrastructure of H1N1 treated as described differed in that the stain penetrated the membrane envelope, and the majority of surface projections were absent;

The ability of the stain to penetrate a greater proportion (subjective observation) of viruses following treatment may be indicative of disruption of the envelope.

To gain an appreciation of the significance of the above changes it should be noted that the surface membrane incorporates various viral proteins and support surface projections (which are required for infection of host cells) whilst encompassing the viral nucleic acid (nucleocapsid) which is required for replication.

“One interpretation of the ultrastructual changes could be the inference that they are consistent with Table XI which show a substantial rise in viral inactivation when H1N1 is exposed to a 4% concentration of MAC/98alive™, for a contact time greater than 120 min.”

Dr. Alex Hyatt BSc (Hons), dipEd, PhD, Senior Principal Research Scientist, Project Leader “bio-Imaging and Ecohealth”, CSIRO, Geelong

In 2009, clinical tests were conducted in partnership with the Sun Yat-Sen Medical University in China/Griffith University (Australia)

The study was conducted to investigate the virucidal properties of MAC/98alive™ against human influenza type A virus (the strain tested was A/H1N1, (commonly known as “Swine Flu”) in vitro and toxicity of various strength doses of 98alive in concentrations of 0.1%, 0.05%, and 0.025%. The study utilised MDCK cells as the test host.

Toxicity tests indicated that MAC/98alive™ was not toxic to the MDCK cells at concentrations of 0.25% and lower.

The study concluded that MAC/98alive™ demonstrated significant virucidal activity against the H1n1 strain, achieving over 70% reductions in the incidence of viral infection of the host cells within four hours as compared to the untreated control group.

Conclusion

These studies indicated that MAC/ 98alive™ is a globally significant therapeutic for the treatment of influenza, whether seasonal or pandemic. It offers the potential for single virucidal multi-dosing treatment acting against a far greater range than current and developmental antiviral and vaccine treatment

As a virucidal treatment, there are no known instances of viral resistance compromising the efficacy of treatment. The combination of direct killing of the virus in the body and the immune properties of MAC/98alive™ offer a uniquely compelling case for its use as the primary treatment for influenza when onsets of symptoms appear.

As such, MAC/98alive™ is well positioned to become not only a day to day treatment for influenza, but also a prophylactic for the prevention or control of all pandemic strains.

Principal Conclusions from Influenza Research to Date:

  • MAC/98alive™ at the proposed dosage of 600mg per day is safe for human consumption
  • MAC/98alive™ has proven rapidly demonstrated properties against all Avian influenza infections
  • MAC/98alive™ causes no side-effects

Recommended Treatment
Table VI

Treatment Recommended dosage for patients ages 7 and above (98alive capsule) Children from 2-7 (98alive syrup)
General flu prevention 1-2 x 150 mg a day 3ml/day
Influenza HINI swine flu strain 4 x 150 mg capsules of 98 alive for 2-3 days, reduce to 2 x 150 mg for further 5 days. (for general relief, use 3 ml of 98alive throat and nasal spray) 3ml/day
Swine flu, HINI swine flu strain 4 x 150 mg for 2-3 days, reduce to 2 x 150 mg for further days (for relief, use 98alive throat and nasal spray) 3ml/day
Avian flu, H5NI flu strain 4 x 150 mg for 2-3 days, reduce to 2 x 150 mg for further days (for relief, use 98alive throat and nasal spray) 3ml/day

Potential Advantages of MAC/98alive™ for Treatment of Influenza

MAC/98alive™ offers a paradigm shift in the treatment strategy for influenza. Being an effective and fast acting blocker for influenza virus infection, MAC/ 98alive™ (Sun Yat-Sen study) reduces the need to incur the excessive cost and inefficiencies of stockpiling vaccines to protect large sections of the population.

Tamiflu™ and Relenza™ currently account for 99% of the drug sales to treat influenza and only reduce the length of infection by an average of a half a day to a day.

The table below outlines MAC/98aliv™e’s advantages over Tamiflu™ and Relenza™.

Table: Potential Advantages of MAC/98alive™ in treating influenza compared to Tamiflu and Relenza.
Table VII

Property Impact of 98alive™
Virucidal
  • 98alive™ blocks the virus rather than only reducing its ability to replicate
Universal application
  • 98alive™ exhibits virucidal activity against avian and all flu variants
  • No restrictions on treatment candidates
  • No regional variation required – 98alive™ kills all strains
No known resistance
Development risks
  • 98alive™ exterminates the virus rather than just making it less efficient in replication
  • Mutation does not impact 98alive™ ability to block all versions of the virus
Speed of action
  • 98alive™ demonstrates virucidal activity within 10 minutes (in vitro)
  • 98alive™ demonstrates rapid absorption into blood serum (in vivo)
  • 98alive™ demonstrates swift virus destruction
Immune system
  • Anticipated acceleration of the virus eradication as 98alive™ and immune system attack it
Other advantages Impact of 98alive
Speed of production
  • 98alive™ can be delivered ready at short notice for emergency treatment of infected populations rather than the six month production time lag for existing antiviral
Cost differential
  • 98alive™ is available at significantly lower price than current antiviral treatments

Current status

Clinical trials

Further larger clinical trials will be required to confirm 98alive™ as a therapeutic treatment (as it has shown in small sample lots) for influenza. These trials are on-going.