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Our Technology

Technological innovation and advancement of the relevant field of knowledge or practice.

Our product is a cyclic lipopeptide that has potent fungicidal activity and minimal toxicity in an animal model. Current antifungals are fungistatic or moderately fungicidal. A potent fungicidal antifungal will be more effective than a fungistatic antifungal in an immunocompromised individual, as in the case of chemotherapeutic patients.

Specific problem or need that is addressed by occidiofungin.

There are problems associated with potency, spectrum of activity and toxicity with the current antifungals used to treat serious fungal infections. The present portfolio of treatments, which primarily constitute azoles, interact unfavorably with other medications. This is a serious problem for the use chemotherapeutics in cancer patients. Current antifungals have resistance problems, low spectrum of activity, and are fungistatic as opposed to fungicidal. All antifungals currently used to treat serious fungal infections are toxic to the liver, and cannot be used during pregnancy. Occidiofungin may overcome all these limitations and find itself positioned at the top of the antifungal market. Occidiofungin is a potent fungicidal compound that has minimal toxicity in an animal model. Occidiofungin also has a broader spectrum of activity and has been shown to be effective against fluconazole and caspofungin resistant strains of Candida albicans.

Current stage of development of occidiofungin.

The development of occidiofungin is in the pre investigational new drug (pre-IND) stage. We do have a significant amount of data supporting its continued development for clinical use.

Materials and methods used to produce or manufacture occidiofungin.

The current yield of occidiofungin from culture liquor is approximately 5 mg/L. It is important to note that these yields are sufficient for development of occidiofungin through phase 2 clinical studies. Optimization of production studies have not been done on occidiofungin and production only needs a 10-fold improvement for commercial viability. Production of daptomycin, another nonribosomally produced antimicrobial used to treat Gram positive infections in the clinic, has a typical yield of 50 mg/L. Traditionally, these types of yields are not a problem for nonribosomally produced products.

For preparation of a pre- investigational new drug application (IND) package, we will consult general guidance documents that specify minimal standards for the development of antimicrobial compounds and insight on those elements considered important to the evaluation of clinical studies located on the Internet at The chemistry, manufacturing and controls section of our IND submission will provide enough information to assure the FDA that the identity, strength, quality, and purity of the new drug are adequately characterized to assess its safety and to allow interpretability of preclinical studies and clinical investigations. Dr. Martin Handfield, Director of Research and Development at Oragenics Inc., has agreed to provide us with his expertise in the pre-clinical development of occidiofungin.

Summary of Core Technology
(Summary of work that has been conducted to advance Sano Chemical's core technology)

All three major thresholds for developing a novel antifungal for clinical use have been met by the antifungal occidiofungin.

First threshold is to have a unique chemical composition.

>> Occidiofungin is a hybrid NRPS-PKS whose complete chemical composition has been determined. It is a 1200 Da cyclic glyco-lipopeptide.

>> Second threshold is having a similar or better spectrum of activity as compared to amphotericin B and fluconazole.

>> Minimum inhibitory concentrations (MICs) of occidiofungin against Candida species are between 0.5 and 2.0 µg/mL.

>> Occidiofungin retains its in vitro potency in the presence of 5% and 50% human serum with a minimum lethal concentration (MLC) of 2 and 4 µg/mL, respectively.

>> Pharmacodynamic (Time Kill) experiments revealed that occidiofungin is rapidly fungicidal against Candida albicans.

>> Post-antifungal experiments, where occidiofungin was washed away from the media, still exhibited potent antifungal activity. These experiments suggest that occidiofungin has a strong interaction with its target.

>> Antifungal activity has been demonstrated against a wide array of fungi.

>> Mechanism of action studies suggest an alternate target exists for occidiofungin other than targeting ergosterol production, binding to ergosterol or inhibiting the 1,3-b-glucan synthase enzyme, which are the current therapeutic targets for treating fungal infections.

>> The third threshold is having a similar or better toxicity profile compared to amphotericin B and fluconazole.

>> Female B6C3F1 mice were used to assess the acute toxicological effects of occidiofungin. Mice were given occidiofungin up to 20 mg/kg body weight (single dose) or 2mg/kg body weight daily for 5 days by intraperitoneal injection. All mice survived these dosages. Variables evaluated included body weight, selected organ weights, clinical chemistry, clinical and anatomic pathology, and behavioral phenomena. Key effects included a transient irritation at the site of injection, and body weight reductions. Adaptation seems to be rapid, because these effects were not observed after 5 daily doses. Histological sections did not exhibit organ specific toxicity in liver, lung, thymus, and kidney.

Very few antifungal compounds have met these three criteria. Occidiofungin does hold promise for its potential use as an antifungal therapeutic. Translational preclinical studies that establish proof-of-concept are needed before the compound can be tested in the clinic.

Regulatory Path

Efficacy, pharmacokinetic, and pharmacodynamic studies along with preclinical toxicology and safety pharmacology data provided by a contract research organization will support an application for phase 1 clinical studies in humans. Completion of these studies will enable continued development of the antifungal. Very few drug choices are available for the treatment of serious fungal infection. Successful completion of phase 1 clinical trials would enable a bridge company to raise additional capital via a first option to license agreement with a pharmaceutical company. Successful completion of phase 2 clinical trials would result in a licensing agreement with an interested pharmaceutical company that will conduct the phase 3 clinical trials.

Positive outcome of our pre-IND testing will enable a bridge company to raise the necessary capital for developing occidiofungin for clinical use or a direct licensing agreement with a biotechnology or pharmaceutical company. Phase 1 clinical trials could be initiated in as little as one year following the completion of the pre-IND studies.

We do have access to the technical expertise of Jeffrey Hillman and other research and business development personnel at Oragenics Inc. The company has experience in developing antimicrobial peptide drugs, which we will benefit from throughout the course of our study. Following completion of pharmacokinetic, pharmacodynamic, and efficacy studies, preclinical toxicology and safety pharmacology data will be completed by a contract research organization. We have an estimate from MDS Pharma Services for completing the preclinical toxicology and safety pharmacology studies enabling a Phase 1 clinical trials. These studies will take about 8 months to complete and will cost approximately $7400,000. Phase 1 studies will also be done by a contract research organization. These studies typically take 1.5 to 2 years to complete and will cost between 2 and 5 million dollars.