Molecular Insight Pharmaceuticals Advances Solazed™ For Malignant Melanoma Into Phase 1 Clinical Trial
Cambridge, MA - (Marketwire) - Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today announced the initiation of a Phase 1 clinical trial of Solazed™ (Ioflubenzamide I-131), the Company's targeted radiotherapeutic drug candidate for treatment of malignant metastatic melanoma. The Phase 1 proof-of-concept study is being conducted with the University of Pennsylvania and is funded by a two-year grant from the National Cancer Institute that could total as much as $1.5M to support this stage of development of Solazed.
"Solazed is our fifth product candidate to enter the clinic, demonstrating our leadership in the development of molecular imaging and targeted radiotherapy of cancer," said Daniel L. Peters, President and CEO of Molecular Insight. "We are hopeful that Solazed will offer a much-needed therapeutic option for patients with metastatic melanoma, a form of cancer known to be exceptionally difficult to treat and associated with a high level of morbidity and mortality."
"Targeting receptors over-expressed in cancers with radioactive payloads has the potential to be highly effective in both the in vivo detection and therapy of cancers," said Chaitanya R. Divgi, M.D., Professor of Radiology and Chief, Nuclear Medicine and Clinical Molecular Imaging Section, University of Pennsylvania. "If fruitful, this method could fulfill an unmet need in melanoma, an aggressive cancer with few current effective therapies."
Solazed, a proprietary radiolabeled small molecule, was designed to bind to melanin found in melanomas and deliver a targeted and lethal dose of radiation to cancer cells through the radioactive decay of iodine-131. Melanin is a naturally occurring pigment that is over-expressed in about half of all melanoma tumors. The Phase 1 clinical trial is designed to define the pharmacokinetics, normal organ distribution and radiation dosimetry of Solazed, and confirm localization in human melanomas. Researchers will image the distribution of Solazed in 12 patients with confirmed metastatic melanoma. Data from this study will inform the design of subsequent therapeutic dose-ranging studies.
In a nonclinical mouse model of human melanoma, Solazed administered in single or multiple doses significantly reduced tumor volumes for a prolonged period of time and enhanced survival compared to control groups treated with standard chemotherapy. In preclinical safety studies the compound exhibited an acceptable toxicity profile. Solazed was granted Orphan Drug status by the Food and Drug Administration for the treatment of stage 2B-4 metastatic melanoma in September 2008.
About Metastatic Melanoma
The incidence of malignant melanoma is rising faster than that of any other cancer in the United States. According to the American Cancer Society, approximately 70,000 cases of melanoma were expected to be diagnosed in the United States in 2009 alone. Although the prognosis depends on the stage of cancer when diagnosed, effective treatment for metastatic melanoma represents a significant challenge for oncologists. Survival rates for advanced melanoma can range from five to 11 months. The rising incidence of malignant melanomas, the early and widespread occurrence of metastases and the poor response rate to current therapies have created a substantial need for new treatments.
About Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals is a clinical-stage biopharmaceutical company and pioneer in the emerging field of molecular medicine. The Company is focused on the discovery and development of targeted therapeutic and imaging radiopharmaceuticals for use in oncology. Molecular Insight has five clinical-stage candidates in development. For further information on Molecular Insight Pharmaceuticals, please visit www.molecularinsight.com.
Forward-Looking Statements
Statements in this release that are not strictly historical in nature constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our Phase 1 clinical trial of Solazed™, the design of such trial and the goals to be achieved, the therapeutic function of Solazed and treatment of metastatic melanoma, rising cases of melanoma, and medical need for Solazed. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Molecular Insight to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Such factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of Phase 1 clinical trial of Solazed; difficulties or delays in such clinical trial process; difficulties or delays in obtaining regulatory approval for initiating next-phase clinical trials; competition from other pharmaceutical or biotechnology companies in their developments of similar products; and the additional risks discussed in filings with the Securities and Exchange Commission (SEC). The Company's SEC filings are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (EDGAR) at http://www.sec.gov/. Press releases for Molecular Insight Pharmaceuticals, Inc. are available on our website: http://www.molecularinsight.com/. All forward-looking statements are qualified in their entirety by this cautionary statement, and Molecular Insight undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.
SOURCE: Molecular Insight Pharmaceuticals, Inc.