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LEARMONT PHARMACEUTICALS is focused on treating rare cancers using novel combination therapies.

Our first target is metastatic melanoma, where cancerous tumors have invaded regional lymph nodes and in many cases spread (metastasized) to other places throughout the body or distant points in the skin.

Melanoma develops when DNA in the pigment-producing melanocytes — located in the basal layer of the epidermis — is damaged by ultraviolet radiation. Melanoma can occur anywhere on the body, but it is most common in skin that is exposed to sunlight such as the face, neck, hands, and arms. Melanoma can be highly malignant and is more likely to metastasize from the skin to other parts of the body than other types of skin cancer.

Like all cancers, melanoma is a mutation of the cell that causes rapid multiplication which in turn forms dangerous, large masses of tissue known as tumors. Mutated cells spread to other areas of the body through metastases and effectively shut down bodily functions.

Late stage melanoma is a rare disease that when diagnosed, has the ability to destroy the lives of both the infected and their loved ones. Once the melanoma has spread to the degree that it can be deemed as late stage, treatment options become increasingly limited. Many treatments do not work for everyone, and those that do frequently only work briefly before the cancer grows an immunity.

The average 5-year survival rate for melanoma is over 90%. However, for patients with late-stage melanoma, the median survival after the onset of distant metastases is only 6–9 months, and the 5-year survival rate is less than 5%. Between 130,000 – 150,000 Americans have late-stage metastatic melanoma.

LORAZOL® has received Orphan Drug Designation from the US FDA for the treatment of late-stage melanoma. We estimate the size of the U.S. market for LORAZOL at $1 billion, $2 billion worldwide.

LORAZOL is a repurposed combination of two drugs – monobenzone and imiquimod – that has shown efficacy in treating late-stage melanoma.

Imiquimod, a known cancer drug, activates a toll-like receptor (TLR7) and improves the immune system’s ability to recognize cancer cells are not “self.” This effect is not specific to melanoma cells, but rather to all cancer cells.

Monobenzone is a vitiligo-inducing agent that works on melanocyte cells — melanin-producing cells located in the bottom layer of the skin’s epidermis — that produces the protective skin-darkening pigment melanin. Melanoma is a type of skin cancer that develops when melanocytes start to grow out of control. Monobenzone chemically modifies melanoma proteins so that they look foreign to the immune system, i.e., it makes them less “self.”

Together, monobenzone + imiquimod creates a specific and targeted immune response against the melanoma cells and immune cells reprogramed to kill melanoma at the skin, that can now travel to areas of the body and attack cancer tumors.

A previous Phase 2 trial using this monobenzone + imiquimod combination was conducted on 25 patients, of which 21 were evaluable. All patients had Stage III or IV melanoma that had progressed to non-resectable cutaneous melanoma metastases.

Using a threshold of p=< 0.05 and a power of 80%, the study was designed to conclude sufficient treatment efficacy to justify further studies if 38% or more of the patients had complete or partial response. All patients except one had undergone prior lymph node dissection.

Seventeen patients received study drug for at least 12 weeks. Four patients of the 21 stopped treatment after six weeks due to local progression.

Eight out of 21, or 38% of patients had full or partial clinical response at 12 weeks. Extended treatment for an average of 16 weeks resulted in full or partial clinical response in 11 of 21 patients, or 52%.

Learmont Pharmaceuticals is in the process of developing advanced formulations of the combination drug to improve stability and convenience of use.

A confirmatory Phase 2 study of LORAZOL is planned to begin in 2020.