NIH / NIMH Funding Opportunities for NeuroAIDS Treatment

NIH / NIMH Funding Opportunities for NeuroAIDS Treatment

Jing Bao, M.D., Ph.D.

Program Officer - Preclinical Therapeutics Development Program

HIV Pathogenesis, Neuropsychiatry, and Treatment Branch

Center for Mental Health Research on AIDS

National Institute of Mental Health / NIH

Jing Bao, M.D., Ph.D.

Program Officer - Preclinical Therapeutics Development Program

HIV Pathogenesis, Neuropsychiatry, and Treatment Branch

Center for Mental Health Research on AIDS

National Institute of Mental Health / NIH

20th International Conference

on Antiviral ResearchApril 29 - May 3, 2007

Westin Mission Hills Resort Palm Springs, California

20th International Conference

on Antiviral ResearchApril 29 - May 3, 2007

Westin Mission Hills Resort Palm Springs, California

National Institutes of Health (NIH)

• Nation's medical research agency – making important medical discoveries that improve health and save lives

• A part of the U.S. Department of Health and Human Services, the primary Federal agency for conducting and supporting medical research

• Composed of 27 Institutes and Centers • Provides leadership and financial support

to researchers in every state and throughout the world

NIMH Mission: To reduce the burden of mental illness and behavioral

disorders through research on mind, brain, and behavior

• Division of Adult Translational Research

• Division of AIDS and Health & Behavior Research

– Center for Mental Health Research on AIDS

– Director: Ellen Stover, Ph.D.

• Division of Services and Interventions Research

• Division of Pediatric Translational Research

• Division of Neuroscience and Basic Behavioral Science

• Division of Extramural Activities

Center for Mental Health Researchon AIDS (CMHRA)

Supports domestic and international studies to:

• develop behavioral change and prevention strategies to reduce the transmission of HIV and other sexually transmitted diseases (STDs)

• develop and test interventions to reduce the neuropsychiatric

morbidity associated with HIV infection; clarify the impact of using new biomedical technologies on HIV risk behaviors

• clarify the pathophysiology of HIV CNS infection and associated motor/cognitive disturbances; identify the role of couples, families, and communities in preventing and adapting to HIV/STDs

• develop therapeutic agents to prevent or reverse the effects of HIV on the CNS; and improve the effectiveness and efficiency of mental health services relevant to HIV infection and people living with HIV and co-occurring mental illness

CMHRAHIV Pathogenesis, Neuropsychiatry, and Treatment Branch:

Contact: Dianne M. Rausch, Ph.D. (Deputy Director CMHRA)

– Mechanisms of Neuropathogenesis Program (9A-ASNP)Contact: Jeymohan Joseph, Ph.D.

– Viral/Host Genetics Program (9A-ASNG)Contact: Jeymohan Joseph, Ph.D.

– Neuropsychology/Neuropsychiatry of HIV Infection Program (9A-ASNM)Contact: David M. Stoff, Ph.D.

– HIV-Therapeutics/Clinical Trials & Psychiatric Pathogenesis Program (9A-ASNK)Contact: Kathy Kopnisky, Ph.D.

– Pre Clinical Therapeutics Development Program (9A-ASNK1)Contact: Jing Bao, M.D., Ph.D.

HIV Infection

Neurological Complications Psychiatric Complications

HIV dementiaCognitive disordersCNS infectionsPolyneuropathies

Mood disordersDepressionManiaPsychosis

Raines, Radeliffe, and Treisman, 2005

Antiretroviral Agents

Neurological Complications

Psychiatric Complications

Raines, Radeliffe, and Treisman, 2005

Raison et al., 2005

Bi-Directional Bi-Directional CommunicationCommunication

Immune system “talks” to the brain –

releases cytokines, releases cytokines, causes behavioral causes behavioral changeschanges

the brain “talks” to the immune system -

releases hormones, etc. releases hormones, etc. that regulate immune that regulate immune responsesresponses

Currently there is no single best approach to the CNS-related consequences of HIV

• NNRTIs (e.g., efavirenz): can penetrate CNS but cause significant side effects

• NNTIs (e.g., zidovudine): effective in suppressing CNS viral load and symptoms but can cause neuropsychiatric side effects

• PIs less likely to produce depression but have lower CNS penetration and more interactions with psychotropics

Need: Novel agents that are effective and tolerable for HIV CNS disease

Preclinical Therapeutics Development for NeuroAIDS

• R21 (PA- 07- 528)

http://grants1.nih.gov/grants/guide/pa-files/PA-07-528.html

• R03 (PA- 07- 529)

http://grants1.nih.gov/grants/guide/pa-files/PA-07-529.html

• Novel assays, in vitro/vivo models (rodent or SIV in particular) useful for drug screening.

• Studies that ameliorate HIV or HAART-related neurotoxicity

• Basic and pilot clinical therapeutics research to understand the biological consequences of taking anti-retroviral medications in the presence of other medications (particularly psychiatric medications) used to treat comorbid conditions

Preclinical Therapeutics Development for NeuroAIDS

R21 (PA- 07- 528) and R03 (PA- 07- 529)

“Therapeutics Development for HIV/AIDS-Associated

Neuropsychological Disorders”

• SBIR: PA-06-432 http://grants1.nih.gov/grants/guide/pa-files/PA-06-432.html

• STTR: PA-06-433 http://grants1.nih.gov/grants/guide/pa-files/PA-06-433.html

• Small Business Innovation Research (SBIR) Set-aside program for small businessconcerns to engage in federal R&D --

with potential for commercialization

• Small Business Technology Transfer Research (STTR)

Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization

Program Descriptions

2.5%

0.3%

SBIR/STTR: 3-Phase ProgramSBIR/STTR: 3-Phase Program

PHASE I Feasibility Study

PHASE II Full Research/R&D

PHASE III Commercialization Stage Use of non-SBIR/STTR Funds CAP (Commercialization Assistant program)

“Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders”

SBIR (R43/44) and STTR (R41/42)

1. Novel agents, methods, biomarkers, and drug delivery technologies that can directly or indirectly eliminate/eradicate HIV reservoirs in the brain

2. Novel assays/models of neurotoxicity and treatment efficacy measures are invited as are novel in vitro/vivo models that can be used for screening potential therapeutic agents

3. Studies that examine agents or therapeutic strategies that protect/ameliorate/treat the long-term side effects of antiretroviral agents in the presence or absence of psychotropic medications

4. Development of adjunctive therapies against the consequences of HIV in the CNS and/or mental illness comorbidity

5. Phase I & II clinical trial studies

“Therapeutics Development for HIV/AIDS-Associated Neuropsychological Disorders”

(SBIR/STTR)

• Phase I: $250,000/year for 2 years

• Phase II:$450,000/year for 3 years

• Receipt dates: May 7, Sep 7, January 7

National Institutes of Health/ NIMH

Funding Opportunities For Pre-clinical and Clinical Therapeutics Development for NeuroAIDS

http://grants1.nih.gov/grants/guide/pa-files/PA-06-528.html (R21) http://grants1.nih.gov/grants/guide/pa-files/PA-06-529.html (R03)

http://grants1.nih.gov/grants/guide/pa-files/PA-06-432.html (SBIR) http://grants1.nih.gov/grants/guide/pa-files/PA-06-433.html (STTR)

• Novel agents, methods, biomarkers, nanoparticles, and drug delivery technologies to eradicate HIV reservoirs in the brain

• Novel in vitro/vivo models of neurotoxicity and treatment efficacy measures• Novel therapeutics and adjunctive agents that attenuate the long-term side effe

cts of antiretroviral agents • Drug-drug interactions between ARVs and psychotropics• Development of IND applications• Phase I and II clinical studies

$275K for the two-year period (R21) $50K per year for two years (R03) $250K for phase I for up to two years and $450K for phase II for up to three year

s may be requested (SBIR/STTR)

NIMH supports the development of innovative technologies /approaches for the treatment of HIV/AIDS-associated mental and neurological disorders, including but not limited to:

Contacts

• Kathy L. Kopnisky, Ph.D. 301.443.7726 KKOPNISK@MAIL.NIH.GOV

• Jeymohan Joseph, Ph.D. 301.443. 6100

JJEYMOHA@MAIL.NIH.GOV

• David M. Stoff, Ph.D.301.443.4625 DSTOFF@NIH.GOV

• Jing Bao, MD, Ph.D.301.443.8542

BAOJ@MAIL.NIH.GOV

• Kathy L. Kopnisky, Ph.D. 301.443.7726 KKOPNISK@MAIL.NIH.GOV

• Jeymohan Joseph, Ph.D. 301.443. 6100

JJEYMOHA@MAIL.NIH.GOV

• David M. Stoff, Ph.D.301.443.4625 DSTOFF@NIH.GOV

• Jing Bao, MD, Ph.D.301.443.8542

BAOJ@MAIL.NIH.GOV