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Baltimore Highlands, MD, United States

FASGEN Inc. and Johns Hopkins University | Date: 2010-01-13

A pharmaceutical composition comprising a pharmaceutical diluent and a compound of formula IV wherein R

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.49M | Year: 2004

DESCRIPTION (provided by applicant): Phase I Ovarian cancer is the fifth leading cause of cancer death among U.S. women and has the highest mortality rate of all gynecologic cancers, with 23,400 new cases and 13,900 deaths projected in 2001. Screening

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 535.70K | Year: 2002

DESCRIPTION (provided by applicant): In 2000, the U.S. had over 16,000 cases of infectious tuberculosis and an estimated 10-15 million latent cases. Despite prolonged treatment regimens with significant side effects, reports of drug resistant TB in 43 states, and an estimated $345 million market opportunity, few new drugs to treat TB are in development. FASgen's SBIR Phase I goal is to choose a lead anti-tuberculosis candidate from 6 molecules active in vitro against Mycobacterium tuberculosis. Phase I specific aims are: 1) resupply candidate compounds and determine purity and chemical and biological stability; 2) determine minimum inhibitory concentrations (MICs) against a panel of mycobacteria in vitro; 3) determine in vitro cytotoxicities (lC50s) against Vero cells; 4) determine maximum tolerated dose (MTD) and dose limiting toxicity in mice for compounds with selectivity index (MTD/IC50) >10; 5) test the best compound in a murine inhalation model of TB; 6) verify that the MTD is not substantially different in immunocompromised (beige) mice; 7) test whether the best anti-tuberculosis compound is also active against M. avium in an immunocompromised mouse model; 8) repeat/confirm efficacy in animal models. In SBIR phase II, the lead compound will undergo safety/toxicology testing in animals and Phase I/Il safety and Phase II efficacy testing in man, most likely against multidrug resistant TB.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 100.00K | Year: 2007

DESCRIPTION (provided by applicant): During the last decade, increasing interest has developed in fatty acid synthase (FAS) as a potential diagnostic and therapeutic target for human cancer. These notions are based on two fundamental observations: [1] FAS is highly expressed in most common human cancers, and [2] pharmacological inhibition of FAS leads to apoptosis of human cancer cells in vitro and in vivo. FAS is the enzyme which catalyzes the de novo synthesis of fatty acids predominantly from dietary carbohydrates. In addition to its expression in human cancers, our collaborators have found that FAS circulates at high levels in the blood of colon, breast, lung, ovarian, and prostate cancer patients compared to normal subjects. Recent data have emerged which directly impact FAS as a biomarker for cancer: [1] FAS elevations have been found to occur in the blood of obese subjects with non-alcoholic steatohepatitis, and [2] FAS derived from tumor cell lines is phosphorylated on threonine residues while FAS from non-transformed cells is not phosphorylated. These findings will enable the development of a diagnostic ELISA serum test for human cancer based on phosphorylated FAS which would not react with FAS derived from normal tissues such as liver. The goals of this Phase I SBIR are to determine that FAS derived from human cancer is selectively phosphorylated and detectable in the serum of cancer patients but not in the sera of obese subjects. This tumor selective phospho-FAS would form the basis for the development of a cancer-selective FAS ELISA assay for the Phase II application. The early diagnosis of cancer enables more effective therapy and enhances patient survival and quality of life. Fatty acid synthase is present at high levels in most common human cancers including colon, lung, prostate and breast cancer. The goal of this proposal is to advance the development of a blood test for cancer based on the identification of FAS which will broadly identify the presence of most human cancer.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 447.87K | Year: 2005

DESCRIPTION (provided by applicant): Tuberculosis poses a major global public health problem. Nearly one-third of the world's population (approximately 2 billion people) harbors latent TB infections. An estimated 8 million cases of active TB are diagnosed annually and approximately 2 million people die of the disease. Additionally, the pandemic of HIV disease is resulting in marked increases in morbidity and mortality due to tuberculosis. To complicate matters further, surveys in several areas of the world, including the United States, have shown that up to 10% to 15% of new infections are now due to multiple drug resistant tuberculosis (MDR-TB). Recently, a new class of small molecules, beta-sulfonylacetamides, has been shown to have potent activity against slow-growing pathogenic mycobacteria. FAS20013, in particular, has potent bactericidal activity against M. tuberculosis and MDR-TB. The compound targets a mechanism quite distinct from all currently used drugs. Resistant organisms have yet to be induced in the laboratory or encountered in clinical isolates. FAS20013 kills M. tb relatively quickly, including organisms engulfed in macrophages. The compound also kills organisms equally well that have been adapted to an hypoxic existence (the Wayne model of latency) in contrast to INH and rifampin that are essentially inactive. FAS20013 is orally bioavailable and has the potential of becoming an important therapeutic that can be used to treat M. tb and MDR-TB infections alike as well as to "sterilize" tissue lesions including those of latent infections. The goals of this proposal are to: 1) provide a supply of FAS20013 in the highest state of purity possible, 2) confirm and extend the preliminary studies of the key therapeutic properties of FAS20013, 3) define the pharmacokinetic basis for optimal therapy, 4) formulate FAS20013 to enable an optimal in vivo treatment regimen, 5) complete preliminary toxicity studies of the newly-formulated therapeutic and 6) examine the efficacy of the newly-formulated therapeutic in treating active infections with M. tb and MDR-TB in the mouse model, as well as latent infections. These data will describe the feasibility of treating mycobacterial infections in humans by this method.

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