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Molecular Insight Pharmaceuticals, Inc. (MIPI) Announces Initiation of Phase 2 Trial for Prostate Cancer Molecular Imaging Drug  
9/25/2012 9:01:29 AM

CAMBRIDGE, MA--(Marketwire - September 24, 2012) - Molecular Insight Pharmaceuticals, Inc. today announced the initiation of a Phase 2 clinical trial of the Company's lead prostate cancer molecular imaging agent, 99mTc-MIP-1404. MIP-1404 is being developed to detect the location and extent of prostate cancer in men who are newly diagnosed or have recurrent or progressive disease. MIP-1404 is an internally-developed small molecule which leverages Molecular Insight's proprietary single amino acid chelate technology (SAAC) and binds to the extracellular enzymatic domain of prostate specific membrane antigen (PSMA) with high affinity. PSMA is a protein found on the surface of approximately 95% of prostate cancer cells and is a validated target for the detection of primary and metastatic prostate cancer. Upon binding to PSMA, MIP-1404 selectively concentrates in prostate cancer cells allowing them to be visualized.

Nelson K. Stacks, Chief Executive Officer, noted, "By targeting PSMA, 99mTc-MIP-1404 has the potential to visualize the presence of metastatic prostate cancer with vastly improved sensitivity and specificity. Current detection methods, such as bone scans, while sensitive for bone metastasis, lack specificity and are unable to effectively monitor changes in disease burden, especially regression. With the World Cancer Research Fund International statistics predicting that the number of new prostate cancer cases will double to almost 1.7 million by 2030, imaging agents that will more accurately detect and stage prostate cancer, as well as monitor the patient's response to therapy, will enable improved disease management and reduce the overall cost of treatment."

Trial Design
This is a Phase 2 international multi-center open-label study of up to 120 high-risk prostate cancer patients scheduled for a clinically-indicated prostatectomy and extended pelvic lymph node dissection. Patients will receive a single intravenous dose of 99mTc-MIP-1404 followed by SPECT/CT scan three to six hours after administration. Imaging will be performed within three weeks of scheduled prostatectomy and extended pelvic lymph node dissection. The 99mTc-MIP-1404 image data will be evaluated for tissue distribution of the drug and the ability to detect prostate cancer within the prostate gland and lymph nodes. The extent and location of prostate cancer within the prostate gland and the ability to detect the presence of metastatic prostate cancer within pelvic lymph nodes will also be assessed. The imaging results will be compared with histopathology results as the truth standard. Clinical safety of 99mTc-MIP-1404 will also be determined.

"In our earlier clinical studies in patients with metastatic prostate cancer, whole body planar imaging demonstrated that 99mTc -MIP-1404 rapidly visualized lesions in lymph nodes and bone as early as 30 minutes post injection," commented Dr. John W. Babich, President and Chief Scientific Officer. "SPECT/CT images demonstrated clear visualization of involved lymph nodes that would be considered 'normal' by CT or MRI scans based on size criteria. We could also visualize disease within the prostate gland with excellent lesion contrast compared to normal prostate tissue as confirmed by pathology. When compared with conventional bone scans, in general more lesions were visualized with 99mTc-MIP-1404." Dr. Babich continued, "We are continuing to develop our prostate cancer product pipeline. In parallel with MIP-1404 for imaging prostate cancer, we are also developing 131I-MIP-1095 as a targeted systemic radiotherapy for metastatic prostate cancer. We expect to file an IND for MIP-1095 in the fourth quarter of 2012. Other research focuses on developing second generation radiotherapeutics for metastatic prostate cancer that will allow us to employ alternative beta- and alpha-emitting radionuclides to enhance tumor control and ease of clinical use. We are also evaluating radiation sensitizers in combination with our systemic radiotherapeutics in order to enhance tumor kill and prolong the duration of response. Our ultimate strategy is to develop a comprehensive targeted radiotherapy approach to hormone refractory prostate cancer leading to a significant improvement in the quality and duration of the lives of men with late-stage prostate cancer."

This Company-sponsored trial will be conducted at approximately 10 sites within the U.S. and at approximately 25 sites in Western, Central and Eastern Europe as well as in Russia. For additional information about this trial, please go the Company website: www.molecularinsight.com and click on the heading In the Clinic.

Molecular Insight's prostate cancer franchise is based on a two-prong approach -- addressing both the diagnostic and therapeutic critical unmet needs of the prostate cancer patient. In addition to the diagnostic agent, 99mTc-MIP-1404, the Company is also developing another small molecule inhibitor of PSMA, 131I-MIP-1095, designed for the treatment of prostate cancer. In pre-clinical models, 131I-MIP-1095 has shown high uptake and retention within prostate cancer tumors, thereby delivering a lethal radiation dose to the tumor resulting in targeted cell death of prostate cancer while minimizing the dose to normal tissue. The pre-clinical data demonstrated that 131I-MIP-1095 treatment resulted in significantly reduced tumor burden for a prolonged period of time. The ability to specifically deliver radiation to prostate cancer cells anywhere in the body is a desirable advance -- allowing a commonly used therapy of radiation to be applied to a systemic disease.

About Molecular Insight Pharmaceuticals, Inc.
Molecular Insight is a clinical-stage biopharmaceutical company focused on the critical unmet diagnostic and therapeutic needs of the prostate cancer patient. The Company is targeting the development of a proprietary small-molecule chemistry platform to improve detection of primary and metastatic prostate cancer and to provide a novel systemic radiotherapy for relapsed and metastatic prostate cancer. For additional information, please visit the Company's website: www.molecularinsight.com.


Contact:
Deborah S. Lorenz
Corporate Communications Consultant
Molecular Insight Pharmaceuticals, Inc.
617.871.6734
dlorenz@molecularinsight.com