DESCRIPTION: (Verbatim from the Applicant's Abstract) The goal of this Phase I SBIR application is to develop a long acting injectable antidepressant for use in depressed, non-compliant HIV-seropositive individuals. HIV-seropositive individuals have increased rates of… More

DESCRIPTION (provided by applicant): The objective of this Phase II application is to develop a sensitive quantitative biomarker of drug-induced neuronal degeneration, particularly associated with drugs of abuse. We have shown that during neuronal degeneration the neuronally localized protein… More

DESCRIPTION (provided by applicant): The objective of this Phase II application is to develop a sensitive quantitative biomarker of drug-induced neuronal degeneration, particularly associated with drugs of abuse. We have shown that during neuronal degeneration the neuronally localized protein… More

The objective of this Phase I feasibility study is to develop a sensitive biomarker for quantifying neuroprotectant drug efficacy in a rat model of traumatic brain injury (TBI). Currently, no widely accepted biochemical marker that quantifies neuronal injury in rat TBI models is available. We have… More

DESCRIPTION (provided by applicant): The objective of this Phase I application is to develop a new quantitative clinical biomarker for subarachnoid hemorrhage (SAH). Acute headache is initially screened for SAH by computed tomography (CT). CT-negative patients suspected of SAH are then screened… More

DESCRIPTION (provided by applicant): The objective of this Phase I application is to develop a sensitive biomarker for quantifying neurotoxicity and neuroprotectant efficacy in meningitis. Previous research documents that brain injury caused by meningitis affects multiple brain areas with a… More

DESCRIPTION (PROVIDED BY APPLICANT): Phase 2 Discovery is developing a synthetic melatonin analog (PD6735) for the treatment of sleep disorders. PD6735 is being developed as a safe and effective treatment for sleep disorders that lacks the side effects of current first-line sleep medications. … More

DESCRIPTION (PROVIDED BY APPLICANT): Phase 2 Discovery is developing a synthetic melatonin analog (PD6735) for the treatment of sleep disorders. PD6735 is being developed as a safe and effective treatment for sleep disorders that lacks the side effects of current first-line sleep medications. … More

DESCRIPTION (provided by applicant): The objective of this Phase I feasibility study is to develop a reliable biomarker of neuronal damage in a validated mouse model of amyotrophic lateral sclerosis (ALS). Currently, there is no widely accepted biomarker to quantify ALS-induced motor neuron injury.… More

DESCRIPTION (provided by applicant): The objective of the present Phase 1 feasibility study is to develop a quantitative serum-based biomarker for detecting neuronal damage in mild traumatic brain injury (TBI). Postconcussion Syndrome (PCS) is believed to be the cause for much if not all of the… More

DESCRIPTION (provided by applicant): The National Institute of Drug Abuse has indicated, "NIDA's top research priority is to find a medication to block or greatly reduce the effects of cocaine to be used as part of a comprehensive treatment program." The purpose of the present FAST TRACK Phase 1… More

DESCRIPTION (provided by applicant): Despite an understanding of the pharmacological basis of cocaine abuse there is no effective pharmacotherapy, suggesting that pharmacotherapy may be impractical. An alternative approach is to: develop an immunotherapy that directly targets cocaine. We have… More

DESCRIPTION (PROVIDED BY APPLICANT): Phase II Discovery, Inc. is developing a synthetic melatonin analog (PD6735) for treating sleep disorders that lacks the side effects of current first-line sleep medications. This Phase 1 proposal will examine the safety and tolerability of PD6735 at doses up… More

DESCRIPTION (provided by applicant): Obesity has risen to epidemic proportions in the United States, contributing to over 52 billion USD per year in direct medical costs. Limited treatment options and significant side effects of currently used Pharmaceuticals necessitate the search for new and… More

DESCRIPTION (provided by applicant): Phase 2 Discovery is developing a synthetic melatonin analog (PD6735) for the treatment of jet lag. No medications are currently approved by the FDA for treatment of jet lag. Medications used "off-label" for jet lag possess undesired side effects. PD6735 is… More

DESCRIPTION (provided by applicant): The goal of this Phase 1 SBIR proposal is to identify lead drug candidates from a library of tumor necrosis factor a (TNF-alpha) inhibitors for treating amyotrophic lateral sclerosis (ALS). ALS is a motor neuron disorder that affects tens of thousands of… More

DESCRIPTION (Provided by applicant): P2D, Inc. is developing a synthetic melatonin analog, PD6735, for the treatment of anxiety. Preliminary Studies suggest that PD6735 reduces anxiety in rodents. Additional pre-clinical studies indicate that PD6735 is safe and is a high-affinity melatonin agonist… More

DESCRIPTION (provided by applicant): The goal of this Phase 1 SBIR proposal is to determine whether the melatonin analog PD6735 (6-chloro- (R) B-methyl melatonin) is neuroprotective in a rat traumatic brain injury (TBI) model. A critical and largely unmet need exists for effective TBI… More

DESCRIPTION (provided by applicant): Cholestasis (or pathologic jaundice) is the most common sign of liver disease in children, and results from genetic defects in genes that play a critical role in bile formation and transport. In adults, mutations in the same genes also cause debilitating liver… More

DESCRIPTION (provided by applicant): Despite an understanding of the pharmacological basis of cocaine abuse no effective pharmacotherapy has been developed, suggesting that pharmacotherapy may be impractical. An alternative approach is to develop an immuno therapy that directly targets cocaine. To… More

DESCRIPTION (provided by applicant): The goal of this Phase 1 SBIR proposal is to identify drug candidate(s) from a tumor necrosis factor a (TNF-a) inhibiting library of compounds for treating Parkinson's disease (PD). PD is a progressive, neurological mov ement disorder characterized by massive… More

DESCRIPTION (provided by applicant): Currently, the non-selective dopamine (DA) transport inhibitors methylphenidate and d- amphetamine are the only approved first line treatments for Attention Deficit/Hyperactivity Disorder (ADHD). As both drugs are Sched ule II drugs of abuse primarily… More

DESCRIPTION (provided by applicant): Extensive research suggests that cocaine's abuse potential is associated with direct binding and inhibition of the DA transporter. Our proprietary compound, PD2007 is a high affinity DA transport inhibitor that possesse s several important characteristics of an… More

DESCRIPTION (provided by applicant): P2D Inc. is developing a synthetic melatonin agonist, PD6735, for the treatment of depression. Preliminary Studies indicate that PD6735 produces an antidepressant-like effect in rodents. Additional preclinical studies i ndicate that PD6735 is safe and is a… More

DESCRIPTION (provided by applicant): CONFIDENTIAL. P2D, Inc. is developing the synthetic melatonin analog PD6735 as a treatment for insomnia. Insomnia is highly prevalent in the United States, affecting 24% percent of the American population. The major ba rrier to sleep aid use is the side effect… More

DESCRIPTION (provided by applicant): P2D, Inc. is developing a synthetic melatonin analog (PD6735) for treating sleep disorders and circadian rhythm disorders. Clinical studies suggest that PD6735 is safe, well tolerated and effective in reducing sleep lat ency in non-elderly adults with primary… More

DESCRIPTION (provided by applicant): Cholestasis (pathologic jaundice) is a very common sign of liver disease in children and adults, and results from genetic defects that play a critical role in bile formation and transport. In adults, mutations in the sa me genes also cause debilitating liver… More

DESCRIPTION (provided by applicant): The purpose of the present SBIR Phase 1 feasibility study is to assess the efficacy of our selective dopamine transport (DAT) inhibitor, PD2007, for the treatment of obesity. The non-selective DAT inhibitor, d-amphetami ne, is a potent anti-obesity treatment in… More

DESCRIPTION (provided by applicant): Satiety Solutions, is developing a novel histamine agonist, betahistine, as a treatment for attention-deficit, hyperactivity disorder (ADHD). Betahistine is a histamine activator which has been found to improve vigilanc e in normal volunteers. Conventionally,… More

DESCRIPTION (provided by applicant): The purpose of the proposed studies is to assess the feasibility of developing a novel Neuropeptide Y (NPY) obesity treatment. Extensive preclinical and clinical studies indicate that NPY receptors are important mediato rs of appetite and obesity. The proposed… More

DESCRIPTION (provided by applicant): The purpose of the proposed SBIR Phase 1 feasibility study is to assess the efficacy of our lead tumor necrosis factor- alpha (TNF1) inhibitor for the treatment of obesity. Two-thirds of U.S. adults are obese or overwei ght according to NIH statistics published… More

DESCRIPTION (provided by applicant): Acute lung injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) are characterized by a rapid and severe respiratory failure, arising after clinical events including major surgery, trauma, multiple transfusions and sepsis. ALI/ARDS have an associated… More

DESCRIPTION (provided by applicant): The purpose of the present SBIR Phase 1 feasibility study is to assess the efficacy of our selective dopamine (DA) transport inhibitor PD2005 in improving cognitive deficits associated with traumatic brain injury (TBI).Executive function deficits like short term… More

DESCRIPTION (provided by applicant): PD2007 is a selective DAT inhibitor that P2D Bioscience (P2D) is developing for the treatment of obesity. PD2007 is an analog of benztropine (Cogentin) a non-Scheduled, safe FDA-approved drug in clinical use for over 40years. Structure-activity-relationship… More

DESCRIPTION (provided by applicant): SBIR Phase 1 preclinical studies demonstrate the efficacy of our proprietary compound, PD2005, for treating Attention Deficit/Hyperactivity Disorder (ADHD). PD2005 is a selective dopamine (DA) transport inhibitor that P2D is developing for the treatment of… More

DESCRIPTION (provided by applicant): The demographic development in most Western countries predicts that age-associated diseases and their prevention will become an important social, economic and medical topic. Somatic stem cell activity is critical for tissue regeneration. There is a successive… More

DESCRIPTION (provided by applicant): The goal of this application is to develop tumor necrosis factor (TNF )-inhibiting compounds as neuroprotectant drugs for treating Alzheimer's disease (AD). Current FDA-approved AD interventions are symptomatic treatments with limited efficacy which do not… More

DESCRIPTION (provided by applicant): Cholestasis (or pathologic jaundice) is the most common sign of liver disease in children and often results from mutations in genes that play a critical role in bile formation and transport. In adults, mutations in thesame genes also cause chronic cholestasis… More

DESCRIPTION (provided by applicant): Hematopoietic stem and progenitor cell (HSPC) transplants are a first-line treatment for multiple forms of cancer. The current standard of care for obtaining HSPCs for a transplant is mobilizing HSPCs from bone marrow into peripheral blood by the cytokine… More

DESCRIPTION (provided by applicant): The proposed SBIR program aims to develop a rapid point-of-care (POC) prognosticative assay device that provides clinically actionable data to predict onset of high intracranial pressure (HICP) after a severe traumaticbrain injury (sTBI). Delayed onset of HICP is… More