Solazed is a targeted radiotherapeutic that Molecular Insight intends to develop for the treatment of malignant metastatic melanoma, the most serious type of skin cancer. Solazed is a radioiodinated small molecule that targets melanin, a naturally-occurring pigment found in high concentration in about half of all metastatic melanomas. Solazed is an iodine-131 labeled small molecule that binds selectively to melanin that is found in high concentration in melanoma cells. Solazed delivers a lethal dose of radiation to the cancer cells through the radioactive decay of iodine-131 and exhibited a favorable toxicity profile in preclinical evaluations.
The Market Opportunity
According to the National Cancer Institute, the incidence of malignant melanoma is rising faster than that of any other cancer in the United States. Since chemotherapeutic agents have limited activity in the treatment of metastatic melanoma, patients continue to have a poor prognosis and effective treatment still represents a challenge to oncologists. Response rates for metastatic melanoma with currently available treatments range from 10-25%, while advanced melanoma (Stage 4) emphasizes palliation with no evidence that treatment at this stage has any impact on survival, which can range from five to 11 months, with a median survival of eight months. Combination studies also failed to improve survival rates. Thus, the advent of new targeted therapies with specific mechanisms of action may help improve the poor results of current therapeutic regimens.
Clinical Development Plan
Solazed has completed preliminary preclinical data which has shown selective targeting to melanin in human models of malignant melanoma with rapid washout from normal organs. In a human melanoma mouse tumor model, Solazed administered in single or multiple dose schedules significantly reduced tumor burden for a prolonged period of time and enhanced survival compared to controls and standard chemotherapy treatment. Solazed also exhibited a favorable toxicity profile in preclinical evaluations. Based on these findings Solazed has advanced to Phase 1 clinical study to confirm mechanistic proof of concept in man and to define the pharmacokinetics, normal organ distribution, radiation dosimetry and pharmacokinetics.