Phytomedics licenses plant-derived drug compound
anti-inflammatory compound, achieving development of heterogenous
plant-derived products as ethical drugs in the US, while reducing
costs and time frames in comparison to new chemical entities or
biologics with a product that has strong drug market exclusivity.
Plant-derived drugs are considered by analysts to be a viable alternative to the chemically based pharmaceutical industry. The synergistic components found in botanical mixtures represent a largely untapped source of new pharmaceutical products with novel and multiple mechanisms of action.
Recent developments in plant biotechnology have created the tools to produce botanical mixtures at a level comparable to that of pure drug compounds. The thinking is that botanical drug products will ultimately compete along side conventional pharmaceuticals in the $300 billion global pharmaceutical marketplace.
The US patent (5,905,089) refers to the anti-inflammatory properties of sesquiterpene lactones, which were originally discovered and developed jointly by researchers at the Pennington Biomedical Research Centre in LA and Louisiana State University.
Phytomedics become the first company to use sesquiterpene lactone to treat severe inflammatory disorders such as sepsis, septic shock, or septicaemia. Sesquiterpene lactones (SLs) are the active constituents of a variety of medicinal plants used in traditional medicine for the treatment of inflammatory diseases.
In recent years, the anti-cancer property of various SLs has attracted a great deal of interest and extensive research work has been carried out to characterise the anti-cancer activity, the molecular mechanisms, and the potential chemopreventive and chemotherapeutic application of SLs.
Studies stretching as far back as 1979 have shown that sesquiterpene lactones, especially those containing an alpha-methylene-gamma.-lactone group, have been shown to possess activity against tumour growth and general inflammatory reactions.
Phytomedics currently has an anti-inflammatory botanical drug candidate completing a 120-patient, 6-month, Phase II clinical trial for rheumatoid arthritis at 10 centres throughout the US. PMI-005 represents another novel, orally bioavailable, small molecule gene-transcription inhibitor of a variety of pro-inflammatory cytokines including a-TNF, i-NOS, IL-1 beta, and COX-2, which treats severe inflammatory disorders such as sepsis, septic shock, or septicaemia.
"The patent further helps to solidify strong patent protection around PMI-005, one of our anti-inflammatory botanical drug candidates expanding our market leadership in the area of developing novel, ethical pharmaceutical products for severe inflammatory disorders of substantial unmet medical need," said Bertold Fridlender, president and CEO of Phytomedics.
Sepsis is a morbid condition induced by a toxin, the introduction or accumulation of which is most commonly caused by infection or trauma. Septic shock and multiple-organ failure are consequences of the invasive infection.
Septic shock has been estimated to occur in more than 500,000 cases per year in the United States alone. Septic shock is the most common cause of death in non-coronary, intensive care units.
As more antibiotic-resistant strains of bacteria evolve, the incidence of septic shock is expected to increase. Overall mortality rates from septic shock range from 30 per cent to 90 per cent. Aggressive antibiotic treatment and timely surgical intervention are the main therapies, but in many cases are insufficient.
Lipopolysaccharide (LPS) is believed to be the principal agent responsible for inducing sepsis syndrome, which includes septic shock, systemic inflammatory response syndrome, and multiorgan failure.
