Abstract:…ddle and inner ear components of hearing are not capable of producing well-calibrated and high-quality acoustic stimuli that cover the entire frequency range of human hearing and are thus unsuited for rapid evaluation of the range of inner ear damage from ototoxic drugs, noise… more
Abstract:… project is to develop STC101, a biosmilar Herceptin . Trastuzumab is a monoclonal antibody made against the HER2 protein that is overexpressed in 20-25% of patients with breast cancer. Because of high cost associated with prescribing Herceptin , a generic version of this drug… more
Abstract:DESCRIPTION (provided by applicant): Chemotherapy-induced ototoxicity is damage to the inner ear that is caused by the side effects of administered drugs. This can lead to permanent hearing loss and/or tinnitus (continuous ringing in the ear) in the patient. Some of the most… more
Abstract:DESCRIPTION (provided by applicant): Current approaches to treat sudden sensorineural hearing loss (SSNHL) do not maintain inner ear drug concentrations within an appropriate therapeutic window for sufficient lengths of time to achieve therapeutic effect.A novel delivery system… more
Abstract:…, and dangerous medicationerrors. At the foundation of the problem are palatability, accurate dosing, and age-appropriate dosage format challenges. Development of a user-friendly, inexpensive development platform for pediatric reformulation of existing adult drug… more
Abstract:… in 0.5-1.2 million deaths per year. Adults with chronic HBV infection acquired in the perinatal period develop hepatocellular carcinoma at a rate of about 5% per decade, approximately 100-fold higher than the rate among uninfected individuals. Antiviral drugs can… more
Abstract:…ions of recombinant human MG53 to mice are safe and do not produce adverse effects. Other studies showed that subcutaneous injection of MG53 can be effective for therapeutic approaches as well. This project will leverage the expertise at TRIM-edicine in biologic drug… more
Abstract:… protein and derived a current good manufacturing process (cGMP)-quality CHO cell line that is ready to produce material for good laboratory practice (GLP) toxicology. This phase 2 proposal comprises the studies that are expected to provide a strong Investigational New Drug… more
Abstract:… the selective movement of charged molecules through cellular membranes. Many disease states, such as cystic fibrosis, muscular dystrophies, hypertension, and cardiac arrhythmias are caused by ion channel pathologies. Ion channels have been identified by the drug discovery… more
Abstract:…opic of increasing concern in the biopharmaceutical industry, as these aggregates are believed to play an undesirable role resulting in adverse health effects to patients by inducing immunogenicity, altering therapeutic pharmacokinetics, or decreasing efficacy of the drug… more
Abstract:DESCRIPTION (provided by applicant): Despite notable achievements over the past two decades, cancer remains a challenging 21st century epidemic demanding new, more effective drugs. Nitric oxide (NO) is well known to kill cancer cells without harming normal bone marrow cells,… more
Abstract:… of the HPG-axis and GnRH signaling, KISS1R is an attractive new mechanism for treating the cause of PCOS. KISS1R antagonists should dampen GnRH pulsatility and offer the first possibility of treating the disease at the hypothalamiclevel. To date there are no drug-like,… more
Abstract:… Using this protocol, we will then examine the effect of KeraStat on delayed treatment and long-term outcomes in a porcine model of trauma/hemorrhage/shock. These data will be instrumental indeveloping a preclinical data package to be submitted to the US Food and Drug… more
Abstract:… may provide a platform on which regenerative strategies can be built. Keratins have intrinsic cell-binding properties that can be exploited to offer potential new solutions to wound healing and have been shown to be a viable platform for the controlled delivery of various drugs… more
Abstract:… such as structural foams, polymers and paints. Potential applications include the validation of the structural integrity of foams used in the aerospace industry; continuous monitoring of paint processes in the automotive industry; and the validation of pharmaceuticals… more
Abstract:… secretions of anti-inflammatory and regenerative molecules directly into the bloodstream in a dynamic and sustained manner. We now plan to develop an effective clinical protocol for the device for ARF that captures the criticalcomponents of a administering a new drug,… more
Abstract:…one of the leading causes of blindness. The prevalence of neovascular (wet) AMD in the United States is expected to increase to nearly 3 million by 2020. Existing treatments are effective in limiting the progression of the disease but are problematic in both cost of drug and… more
Abstract:DESCRIPTION (provided by applicant): StemSynergy Therapeutics Inc. (SSTI) is a biopharmaceutical company focused on the discovery, development, and commercialization of drugs that target pathways fundamental to stem cells and cancer stem cells. The WorldHealth Organization… more
Abstract:…urvival rate for patients with non-small-cell lung carcinoma (NSCLC) remain almost identical to20 years ago. Current therapies targeting the proliferative mechanisms of NSCLC cancers such as K-RAS and EGFR have been the focus of a large effort in the pharmaceutical industry and… more
Abstract:…, to establish protocols for the procedure and to gather preliminary clinical data. Breast cancer patients will receive a 14C-oxaliplatin microdose a few hours prior to normal biopsy. DNA will be isolated from white blood cells and left over tumor biopsy tissue. Drug-DNA… more
Abstract:… development. PUBLIC HEALTH RELEVANCE: An estimated 33.4 million people worldwide are now living with HIV, and 2.7 million are newly infected every year, with a higher prevalence among women, as women are biologically more vulnerable to HIV than men. Anti-viral … more
Abstract:… (MURR), typical irradiation parameters result in less than 2% of the 152Sm target material being converted into 153Sm. Since chemical methods cannot be used to perform isotopic separation, this means that & gt;98% of the resultant pharmaceutical molecules … more
Abstract:… challenging health problems of the 21st century. Global health care expenditures to treat diabetes and its complications are estimated to have been 376 billion in 2010, of which 198 billion was spent in the United States. Efficacious and convenient pharmaceutical… more
Abstract:DESCRIPTION (provided by applicant): Chemotherapy drugs tend to be highly cytotoxic and genotoxic, with well-documented carcinogenic, mutagenic, and teratogenic effects. Long-term occupational exposure to these highly toxic drugs presents serious health risks (e.g., cancers,… more
Abstract:…. Perhaps most significantly, this work has revealed that cancers can develop in response to mutations in tumor suppressor genes. Tumor suppressor mutations account for ~80% of all cancer mutations, but unlike activating mutations in oncogenes, cannot be targeted by drugs… more
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