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In addition to Azedra, Onalta and Zemiva, we are developing a portfolio of product candidates for oncological molecular imaging and targeted radiotherapy as well as cardiovascular molecular imaging using our proprietary technologies. Applied independently and in combination, these technologies enable the development of innovative and targeted radiotherapeutics and molecular imaging pharmaceuticals that use both small molecules and peptides.
Oncology - TrofexTM
We are developing a non-invasive method for visualization of prostate cancer through molecular imaging. Prostate cancer is the most commonly diagnosed cancer among men in the United States, with approximately 230,000 men newly diagnosed each year. The current standard of care for diagnosis of prostate cancer is biopsy of the prostate gland, with approximately one million procedures performed annually in the United States. However, biopsies have poor sensitivity for initial diagnosis and approximately 10% of patients with a negative first biopsy have cancer diagnosis on a second biopsy. Correct staging of prostate cancer at initial diagnosis, as well as accurate staging and tumor localization with biochemical recurrence, remains generally inaccurate with current imaging techniques. We are engaged in discovery studies of a molecular imaging pharmaceutical for detection of prostate-specific membrane antigen, or PSMA, expression which would enable the detection and monitoring of prostate cancer, with the intention to be able to detect subtle manifestation of metastatic disease in men with elevated serum prostate specific antigen, or PSA, but no other obvious symptoms. Metastatic disease is a disease that can result in the transmission of cancerous cells from an original site to one or more sites elsewhere in the body. We currently have identified a series of compounds that bind PSMA and localize in human prostate tumors. Our next step will be to select the lead compound to carry into preclinical development for human use.
Oncology - SolazedTM
Solazed is a targeted radiotherapeutic that we intend to develop for the treatment of malignant metastatic melanoma, the most serious type of skin cancer. We recently in-licensed the compound from Bayer Schering Pharma Aktiengesellschaft, or Schering. Solazed is a small molecule compound that targets melanin, a naturally occurring pigment responsible for the color of the skin and the dark color of the melanoma tumor. The American Cancer Society estimates that about 59,940 new melanomas will be diagnosed in the United States during 2007. Melanoma is a cancerous tumor that grows out of cells called melanocytes, a type of body cell responsible for pigment in the skin that are found in the lower level of the skin and which make the pigment melanin. Melanoma most often develops in the skin, but it can also occur in other areas of the body. Melanoma is a serious cancer that can spread rapidly throughout the body.
The primary treatment of melanoma usually involves surgical removal of the tumor. However, surgery may not be an option when the tumor exceeds three millimeters in diameter, as it may have already spread to other areas. For those melanoma patients who are not candidates for surgery or whose disease has spread or metastasized, therapeutic approaches such as external beam radiation, chemotherapy and immunotherapy (treatment to modulate the body’s immune system) to elicit a therapeutic response, are often used.
We intend to pursue an indication for Solazed for the treatment of melanin-positive melanoma tumors. We expect to build upon pre-clinical studies performed by Schering to optimize the product formulation and further demonstrate safety and efficacy. Additionally, we intend to build upon independent research experience in humans to design the protocol for a Phase 1 dosimetry study, which we plan to initiate in 2008. Following a Phase 1 dosimetry trial, we intend to conduct dose ranging studies and follow with efficacy studies, most likely in the United States.
Cardiology - MIP-190
We are developing a non-invasive way to assess the progression of heart failure through the monitoring of angiotensin converting enzyme, or ACE, in human hearts. Heart failure is a common syndrome that is increasing in prevalence because people are living longer. According to the American Heart Association, it is estimated that more than five million people in the United States have some form of heart failure, and nearly 550,000 new cases are diagnosed each year. The risk of developing heart failure increases with age, and it is estimated that ten out of every 1,000 people over the age of 65 will be diagnosed with heart failure. Even though medical advances and therapies have improved overall survival rates, the incidence of heart failure has risen steadily. Today, heart failure is the single most frequent cause of hospitalization in people over 65, accounting for between 5% to 10% of all hospital admissions.
In conjunction with scientists at the University of Maryland Medical Center, we have engaged in NIH-sponsored development of cardiovascular compounds to target ACE as a marker for the assessment of heart failure patients. Such compounds would be novel in that they would enable the evaluation of ACE in human hearts with chronic ischemia and heart failure using external imaging. The level of ACE has been shown to increase in the heart muscle as heart failure progresses. A means of non-invasively monitoring ACE levels may allow doctors to better manage heart failure to slow down clinical progression. We currently have identified a lead compound that is radiolabeled using our SAAC technology, which displays strong binding to ACE both in isolated enzymes and in animal studies.
Neurology - MIP-170D
We are developing a potential aid in the objective diagnosis of Parkinson’s disease and Attention Deficit Hyperactivity Disorder, or ADHD. Parkinson’s disease is a neurological disorder with no known cure. Approximately one million Americans suffer from Parkinson’s disease. In 2002, the European Journal of Neurology reported that there is a 20% to 30% misdiagnosis rate in the early stages of Parkinson’s disease. A molecular imaging pharmaceutical which could help distinguish Parkinsonian Syndrome from non-Parkinsonian tremors may be useful to neurologists in diagnosis and treatment of their patients. Our neurology preclinical discovery program, MIP-170D, represents a class of compounds that bind to specific molecular targets in the brain. As molecular imaging pharmaceuticals, these compounds have the potential of aiding doctors in the diagnosis of disorders such as Parkinson’s disease and ADHD. Our next steps will be to select the lead compound to carry into preclinical development for human use.
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