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Leveraging the skin’s own ‘technology’

BioCis Pharma is targeting unmet medical needs in inflammation, allergies, and cancer through application of its proprietary Protodynamic Therapy Concept and unique ProtoCure™ products.
BioCis Pharma Ltd.

BioCis Pharma is a clinical stage drug development company with a focus on cancer and inflammation, and is developing its first products for local use in treating common problems such as dermatitis, psoriasis, and skin and bladder cancer.

BioCis Pharma’s patented core technology is based on more than 18 years of research in immunology and the behaviour of endogenous photoreceptor molecules in the skin and how they can be utilised for designing novel therapeutics. By leveraging nature’s underlying molecular and physiological mechanisms, BioCis Pharma has developed a technology platform based on cis-urocanic acid.

Two areas of benefit

Cis-urocanic acid is a natural constituent of the skin that can be used to break the intracellular pH balance of target cells. This novel ‘Protodynamic’ action has at least two important areas of use: it inhibits the activation of inflammatory cells in cases of inflammation, and induces the apoptosis and necrosis of cancer cells. The extent to which it does this depends on the dose given and how it is formulated.

As an anti-inflammatory agent, cis-urocanic acid in the form of BioCis Pharma’s ProtoCure™ emulsion cream has been shown to prevent the production of reactive oxygen radicals and proinflammatory cytokines, reducing skin-related tissue damage and inflammation. Usage of the cream has proved highly effective in preclinical models and extremely well tolerated.

In the case of oncology, ProtoCure™ anti-cancer products promote changes in cell metabolism and gene expression that lead to the activation of multiple signalling pathways, triggering apoptosis and cell death.

Moving ahead to clinical testing

The first phase of product development will focus on anti-inflammatory applications, using the lead product: ProtoCure™ emulsion cream for dermatitis and psoriasis.

Three clinical studies have been conducted since early 2008 to investigate the pharmacokinetics, safety, and efficacy of ProtoCure™ emulsion cream in healthy volunteers and patients with atopic dermatitis. Subsequent Phase 2b clinical trials will begin in 2009 to demonstrate the therapeutic proof of the concept.

The second phase of clinical development will address the fourth-most common form of cancer in men – non-invasive bladder cancer – through the use of the ProtoCure™ intravesical solution. A clinical trial with cancer patients is expected to start in the first half of 2009.

Product pipeline

BioCis Pharma’s ProtoCure™emulsion cream is a first-in-class pharmaceutical containing a small molecule active substance that produces a local anti inflammatory effect by modifying the intracellular pH balance of inflammatory cells.
> Lasse Leino
(Published in HighTech Finland 2009)