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Cytokine Storm

  1. Anti-“Cytokine Storm” therapy both in systemic infections and topical inflammatory is the new strategy of biodefense. Rapid determination of “Cytokine Storm” and passive therapeutics by using monoclonal antibodies from Anogen-Yes Biotech are attractive options to researchers and clinics.
  2. ALT/ARDSHumanized monoclonal antibody against the chemokine CXCL-8 (IL-8) effectively prevents acute lung injury
  3. Skin infalmmatory: We have developed Abcream - an effective topical formulation of monoclonal antibodies consisting of anti-IL-8 neutralizing antibody that specifically inhibit a key molecule, interleukin-8 (IL-8), which plays pivotal pathological roles in psoriasis when over-expressed in skin.
  4. We are also putting efforts on applying IL-8 to develop Immuno-Assay and therapeutic antibody for early prediction and treatment of severe Hand, foot, and mouth disease (HFMD)

ABCream

IL-8 levels can be elevated 150-fold in psoriatic tissue when compared to normal tissue. Likely effects of IL-8 in causing or promoting tissue damage are a result of IL-8 being a strong chemotaxis factor for neutrophils, a strong growth factor of epidermal cells, and a potent angiogenesis factor.

EFFECTIVENESS

ABCream contains anti-human IL-8 antibodies that neutralize excessive IL-8, which can modulate abnormal proliferation and differentiation of keratinocytes and eliminate the gathering of neutrophils, therefore producing an anti-inflammatory response in the psoriatic skin.

ABCream can block the abnormal blood supply by reducing the angiogenesis factor, IL-8, resulting in the reduction of over proliferating cells.

SAFETY

Murine antibodies used in topical application are able to generate satisfactory therapeutic effect without causing HAMA response (Human Anti-Mouse Antibody), and are therefore safe and appropriate to use in the topical treatment of psoriasis. Humanized antibody can result in a final antibody product that is different in structure from the original mouse antibody, leading to a decrease in specificity or a loss in affinity.

Topical applications do not generally affect the levels and expression of immunological cytokines in the body. Hypersensitive reaction and related symptoms are that are often observed in association with systemic injection of exogenous proteins are avoided.

RESULTS

Anti-IL-8 antibodies are capable of penetrating through skin into psoriatic lesions in sufficient amounts to show therapeutic effects.  Our long-term study has shown that the changes of antibody titer are gradual, indicating that the cream substance has a protective effect on antibody, and the antibody stability is maintained in the cream formulation for at least one year.

ABCream may be effective in treatment of other inflammatory skin conditions as well. Preliminary observations suggest that it may also be used for treatment of eczema, a common skin condition.

Results of Phase III clinical trials in People's Republic of China (Phase IV trials complete as well)

49% to 53.8% of patients achieved a greater than 60% improvement and 12.9% to 15.3% of patients achieved a greater than 90% improvement in PASI scores after a six week treatment cycle with ABCream.



HFMD and IL-8

Hand, foot and mouth disease (HFMD) is a potentially life-threatening illness commmonly seen in children mostly younger than five years of age. HFMD associated with Enterovirus 71 (EV71) and Coxsackievirus A6 (CV-A6), members of the Picornaviridae family in the genus Enterovirus.  Although present globally in most countries including Europe and North America, the largest HFMD outbreaks has been seen in the Asia-Pacific area, for unknown reasons.  HFMD outbreaks are not only increased in recent years, but more severe cases are also more common.  Even worse, the HFMD virus is likely to develop partial variations.  The fatality rate of severe HFMD is higher.    

Hyperglycemia, Pre-albumin and leukocytosis are currently used for clinical prediction of the severity of HFMD. However, they are both insensitive and nonspecific in HFMD patients. 

It has been proved that cytokines and chemokines released by EV71 or CV-A6 infected immune cells contribute to the disease severity. The uncontrolled immune responses result in abnormally elevated expression of cytokines that cause inflammation, tissue damage, pulmonary edema and other pathological damage.  This phenomenon is known as "Cytokine Storm".

Determination of selected cytokines for early prediction of HFMD severity and prophylactic treatment is in urgent need.

The latest research showed that among many cytokines, IL-2, IL-4, IL-6, IL-8, IL-10, MCP-1, IFN-γ, GM-CSF and TNF-α increase in enterovirus infection. IL-8 is strongly associated with the severity of HFMD with massive neutrophil infiltration of tissue and organ.  IL-6 and IL-10, although elevated in HFMD patients, are not related to the disease severity.  Thus, IL-8 level could be used as a predictive marker in the early stages of severe enterovirus infection.  In addition, humanized anti-IL-8 antibody may prevent fatal complications such as brainstem encephalitis (BE), and pulmonary edema (PE) to reduce the mortality of severe HFMD. 

Our project is to develop a new medical device of multiplex cytokine immuno-assay (ELISA) for early prediction of severe HFMD and an effective therapeutic humanized antibody against IL-8. 

Attachments

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