Navigation Links
Inhibikase Therapeutics Receives FDA Clearance for Phase II Trial of IkT-001 to Treat JC Virus Infection, the Cause of Progressive Multifocal Leukoencephalopathy (PML) in Multiple Sclerosis Patients
Date:8/16/2011

ATLANTA, Aug. 16, 2011 /PRNewswire/ -- Inhibikase Therapeutics, Inc., an emerging leader in infectious disease, announced today that it has received FDA clearance to commence a Phase II proof-of-concept trial for its lead compound IkT-001.  IkT-001, a host-directed kinase inhibitor, is intended to clear JC polyomavirus (JCV) infection, the causative agent of Progressive Multifocal Leukoencephalopathy (PML).  This proof-of-concept trial will be conducted in multiple sclerosis (MS) patients on natalizumab (TYSABRI®), a patient group that is at significant risk for developing the potentially fatal PML disease.  JCV progresses to PML only in patients with chronic or drug-induced immune suppression, to include patients diagnosed with clinical AIDS or who are receiving monoclonal antibody treatment for MS, lupus, rheumatoid arthritis, leukemia or lymphoma.

(Logo: http://photos.prnewswire.com/prnh/20110517/CL02791LOGO)

The Phase II trial will be a four-week, open-label, sequential-dose-ranging study of the compound's safety and its antiviral effects against JCV in 48 patients with a relapsing form of MS who receive TYSABRI® infusion therapy.  In addition to closely monitoring the safety and pharmacokinetic profile of IkT-001, the study also will determine the potential antiviral effect of IkT-001 against JCV as measured by the suppression of urinary excretion of JCV.  Led by Jeffrey English, MD, of the Multiple Sclerosis Center of Atlanta, the study will be performed at three to five U.S. treatment centers for MS. All participating centers must be registered with the TOUCH Program for the prescription and infusion of TYSABRI® to patients with MS.

"The launch of this study is a pivotal event for Inhibikase Therapeutics, just 23 months into operations, as we advance a new approach to treating bacterial and viral infectious diseases into the clinic," said Milton H. Werner Ph.D., Chief Executive Officer and President of Inhibikase Therapeutics.  "If IkT-001 proves to be efficacious at suppressing JCV in MS patients on TYSABRI®, then a much broader population of patients at potential risk of contracting PML could benefit from this approach to preempting the virus from reaching the brain and causing the disease.  The common mechanism of action utilized by IkT-001 enables treatment for bacterial and viral infectious disease, thus an efficacious outcome for this Phase II study could clear a path for multiple indications using the same pharmaceutical approach."

About JC Virus and Progressive Multifocal Leukoencephalopathy (PML)

The John Cunningham virus (JCV) is a type of human polyomavirus. It was isolated in 1971 from a patient with progressive multifocal leukoencephalopathy (PML). Human polyomaviruses, like JC and BK, cause PML and other diseases only in the context of immunodeficiency, as in AIDS, or drug-related immune suppression, either for treatment of autoimmune disease, cancer or for solid organ transplant maintenance. JCV infection is very common in the general population, with roughly 60 percent of adult humans likely to have been exposed to the virus; most people acquire JCV in childhood or adolescence.(1)  When immunodeficiency or immunosuppression allows JCV to 'reactivate', the virus preferentially migrates to the brain, destroying oligodendrocytes and astrocytes. This lytic infection leads to cognitive and motor dysfunction (the syndrome PML) and is fatal in 50 percent or more of patients.   The best approach to treating the disease is to attack the virus in its quiescent state before it enters the brain. IkT-001 blocks viral entry into host cells, and therefore could suppress an active JCV infection in at risk patients prior to virus migration into the brain.  There is no currently approved treatment for PML.

About Inhibikase Therapeutics

Founded in 2008, Inhibikase Therapeutics is a private biopharmaceutical company developing novel, small-molecule compounds to treat bacterial and viral infectious diseases through a know-risk development strategy, one that advances a compound against a clinically validated target to proof-of-concept stage on an accelerated timeline.  Its pipeline of validated targets utilizes known chemical entities, as well as novel chemical entities, to treat diseases therapeutically and prophylactically.  By inhibiting human pathways used by multiple bacteria and viruses for reproduction in the patient, the Company's compounds block viral and bacterial reproduction with a lower likelihood of stimulating resistance. Inhibikase Therapeutics is also developing a broad-spectrum antiviral specific for enveloped viruses, opening new avenues for vaccine development and biodefense. For more information, please visit the Company's website at www.inhibikase.com.

(1)   Padgett, B.L. and Walker, D.L. (1973). "Prevalence of antibodies in human sera against JC virus, an isolate from a case of progressive multifocal leukoencephalopathy". J. Infect. Dis. 127 (4): 467-470.

For Further Information Contact:

Milton H. Werner, PhD
President & CEO
Inhibikase Therapeutics, Inc.
(917) 494-0831 (m)
mhwerner@inhibikase.com


'/>"/>
SOURCE Inhibikase Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Inhibikase Therapeutics Discusses New Platform for Infectious Disease Pharmaceuticals at BIOCOM 2009
2. Inhibikase Therapeutics Elects Steven C. Gilman, Ph.D., to Board of Directors
3. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
4. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
5. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
6. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
7. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
8. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
9. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
10. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
11. TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated with Schizophrenia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/7/2017)... Texas , Oct. 6, 2017   Provista, ... with more than $100 billion in purchasing power, today ... news and information. The Newsroom is the ... and industry trends, infographics, expert bios, news releases, slideshows ... having access to a wealth of resources at their ...
(Date:10/4/2017)...  According to the Centers for Disease Control and Prevention (CDC), ... Urgent Care is helping communities across Massachusetts , ... offering no-cost* flu shots through the end of the month. ... regulations. ... a flu shot is by the end of October, according to the ...
(Date:10/2/2017)...  Eli Lilly and Company (NYSE: LLY ... quarter of 2017 on Tuesday, October 24, 2017. Lilly ... with the investment community and media to further detail ... will begin at 9 a.m. Eastern time. Investors, media ... of the conference call through a link that will ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one of the ... new design of the shoulder pad. The shoulder pad provides optimal support and ... pain while using cold therapy. By utilizing ice and water that is circulated from ...
(Date:10/12/2017)... ... , ... Asante, a nationally recognized health system in southern ... home health joint venture through an agreement, effective October 1, 2017, to create ... health company with Asante, delivering clinically integrated care, for the past eight years. ...
(Date:10/12/2017)... ... 12, 2017 , ... Dr. Parsa Mohebi, the Los Angeles ... to the newly revamped Cosmetic Town journal section, featuring articles written ... known as Follicular Unit Extraction (FUE). , Dr. Mohebi says “I ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s ... the 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned and Grand Rapids-based workplace ... Brightest in Wellness® by Best and Brightest. OnSite Wellness will be honored at ... from 7:30 a.m. to 2 p.m. at the Henry Autograph Collection Hotel, located ...
Breaking Medicine News(10 mins):