Molecular Insight Pharmaceuticals, Inc. Reports Preclinical Data on Solazed for Treatment of Metastatic Melanoma at Society of Nuclear Medicine (SNM) MeetingCAMBRIDGE, Mass.--(BUSINESS WIRE)--June 16, 2008 - Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) reported today that it presented positive preclinical data on the pharmacology and mechanism of action of Solazed (MIP-1145), its targeted radiotherapeutic candidate for the detection and treatment of metastatic melanoma, at the Society of Nuclear Medicine's (SNM) 55th Annual Meeting in New Orleans. The company performed a series of studies to identify a lead radiotherapeutic candidate from a library of compounds. MIP-1145 was selected for entry into clinical trials based on its significant melanin-specific tumor uptake and retention in vitro and in vivo, anti-tumor activity and radiochemical stability and solubility profile. Molecular Insight plans to begin a Phase 1 dosimetry trial for Solazed later this year.
MIP-1145 is one of a family of proprietary, small molecule benzamide compounds that target melanin, a naturally-occurring pigment that is overexpressed in approximately 40 percent of melanomas. Molecular Insight in-licensed a library of benzamide compounds from Bayer Schering Pharma in 2007 as part of its strategy to build a robust pipeline in targeted radiotherapeutics for cancer.
"These studies highlight Molecular Insight's stringent internal screening process to determine optimal clinical trial candidates," said John W. Babich, President and Chief Scientific Officer of Molecular Insight. "MIP-1145 demonstrated an excellent profile based on its uptake and retention in human melanoma cell lines both in vitro and in vivo; anti-tumor activity in preclinical models; and solubility and radiochemical stability. Additionally, the compound has potential for use for both PET and SPECT imaging. These studies put us on a track to begin initial human trials with Solazed later this year."
"Molecular Insight acquired exclusive worldwide rights to Solazed from Bayer Schering Pharma last year to advance our strategic commitment to develop and commercialize innovative radiopharmaceuticals for patients with life-threatening diseases," said David S. Barlow, Chairman and Chief Executive Officer of Molecular Insight. "Solazed adds further depth to our strong pipeline of oncology targeted radiotherapeutic and molecular imaging radiopharmaceutical candidates, joining Azedra(TM) and Onalta(TM) for the treatment of neuroendocrine cancers and Trofex(TM) for the detection, staging and monitoring of prostate cancer."
The studies evaluated tissue distribution and uptake of several benzamide compounds in preclinical models. MIP-1145 was selected and further evaluated on the basis of its stability and solubility profile and its potential for use with both SPECT and PET imaging cameras. MIP-1145 binding to melanoma cells in vitro was melanin-dependent and increased over time. The compound demonstrated uptake and prolonged retention in melanin-positive tumors in vivo, along with rapid washout from non-target organs. In addition, single and multiple dose schedules of MIP-1145 significantly reduced tumor burden for an extended period of time and produced no adverse effects.
Melanoma is the most common form of skin cancer, with 62,000 new cases annually. The incidence of the disease is the highest among cancers in the United States. The occurrence of malignant metastatic melanoma is increasing at a faster rate than any other cancer, and current therapies for Stage 3 and Stage 4 malignant melanoma are limited.
The poster study is entitled, "Molecular Targeting of Melanoma with Radiolabeled Benzamides." Authors on the study include: John Joyal, Shawn M. Hiller, Jianqing Chen, John A. Barrett, James Kronauge, and John W. Babich, of Molecular Insight Pharmaceuticals; and Matthias Friebe and Ludger Dinkelborg, of Bayer Healthcare.
About Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals (NASDAQ: MIPI) is a biopharmaceutical company specializing in the emerging field of molecular medicine, applying innovations in the identification and targeting of disease at the molecular level to improve healthcare for patients with life-threatening diseases. The company is focused on discovering, developing and commercializing innovative, molecular radiotherapeutics and molecular imaging pharmaceuticals with initial applications in the areas of oncology and cardiology. Its lead molecular radiotherapeutic product candidates, Azedra and Onalta, are being developed for detection and treatment of cancer. The company's lead molecular imaging pharmaceutical product candidate, Zemiva, is being developed for the diagnosis of cardiac ischemia, or insufficient blood flow to the heart. In addition, the company has a growing pipeline of product candidates resulting from application of its proprietary platform technologies to new and existing compounds. Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts and its website address is: www.molecularinsight.com.
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, our strategy to begin initial human trials with Solazed(TM) later this year, and statements about the development of Azedra(TM), Onalta(TM), Zemiva(TM) and our other product candidates. 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. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Molecular Insight undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Molecular Insight Pharmaceuticals, Inc.
Priscilla Harlan, 617-492-5554
Vice President, Corporate Communications
Posted: June 2008