Navigation Links
ImQuest Pharmaceuticals Receives FDA Approval to Initiate Clinical Trials of a Vaginal Gel for the Prevention of HIV Transmission to Women
Date:7/16/2014

FREDERICK, Md., July 16, 2014 /PRNewswire/ -- ImQuest Pharmaceuticals was recently notified by the US Food and Drug Administration of the approval of its Investigational New Drug (IND) application to study the safety in Phase 1 clinical trials of its vaginal gel containing the nonnucleoside reverse transcriptase HIV Inhibitor IQP-0528. Preclinical studies have shown that IQP-0528 is highly effective against virus strains found throughout the world, prevents HIV transmission in cultured cells, causes sterilization of cultures infected with HIV, and acts in concert with other approved HIV drugs to inhibit the virus. The IQP-0528 vaginal gel is being developed with the goal of preventing the sexual transmission of HIV to women throughout the world.

ImQuest plans to evaluate the safety of the IQP-0528 vaginal gel in a Phase I clinical trial at medical centers in the United States and expects to begin recruiting women for the trial by the end of the year. This marks the company's first product to receive FDA approval for clinical trials.

"The approval of our IND by the FDA is a major and highly significant milestone for ImQuest's Women's Health and Prevention programs focused on the protection of susceptible women from infection," said Dr. Robert Buckheit, Jr., President and Chief Scientific Officer of ImQuest. "In light of the unique properties of IQP-0528 we anticipate that the IQP-0528-containing gel will be a highly successful prevention agent and will be a first step towards our development of subsequent prevention and women's health products."

ImQuest Pharmaceuticals developed the HIV inhibitor in partnership with Samjin Pharmaceutical Co. Ltd of Seoul Korea. Preclinical testing was conducted by ImQuest BioSciences of Frederick, Maryland using the company's newly launched ImQuestSUCCESS™ platform, which enables the rapid identification of drug candidates with a high probability of clinical success early in the discovery and development process. Development of ImQuest's prevention products has been supported in part by the National Institutes of Health and the International Partnership for Microbicides, which is funded by The Bill and Melinda Gates Foundation and The United States Agency for International Development (USAID).

The company plans to submit a second IND to the FDA for approval to test IQP-0528 in a DuoGel™ formulation for protection of both vaginal and rectal virus transmission to men and women early next year – a product which will represent a major advancement for microbicide products in the pharmaceutical industry.

About ImQuest Pharmaceuticals
ImQuest Pharmaceuticals is a leading drug discovery and development company with a highly focused strategy of developing a proprietary portfolio of novel agents for the prevention of infectious disease as well as products for Women's Health. The pipeline includes vaginal gels, dual vaginal/rectal DuoGels™, films and intravaginal rings as prevention products and has significant efforts directed at the use of transdermal delivery of pharmaceutical products. The company has an exclusive development relationship with Samjin Pharmaceuticals with a right of first refusal to their products for the prevention and treatment of infectious disease. ImQuest Pharmaceuticals plans to strategically develop their topical microbicides product pipeline to provide prevention products to both men and women to inhibit the transmission of HIV and other sexually transmitted infectious (STI) organisms. ImQuest Pharmaceuticals' business model is to commercialize exciting new drugs with unique mechanisms of action both independently as well as in partnership with other pharmaceutical companies.  For more information, visit www.imquestls.com.

About ImQuest BioSciences
ImQuest BioSciences is a preclinical contract research and development company that evaluates the potential of new and novel pharmaceutical products. ImQuest provides expert laboratory research services to define the efficacy and toxicity of pharmaceutical products and specialize in the development of drugs, vaccines and biologic products for the treatment and prevention of infectious disease, cancer and inflammatory disease. ImQuest is committed to earning our client's trust and building long term relationships through collaboration, unwavering commitment to quality science and consistent and effective communication. ImQuest has recently released the ImQuestSUCCESS™ platform which will significantly expedite the development of pharmaceutical products with enhanced probability for successful clinical development. ImQuest understands that each product and each client is unique and strives to provide effective solutions. For more information, visit www.imquestbio.com.

Media Contact
Faye Coggins
301-696-0274

Logo - http://photos.prnewswire.com/prnh/20140715/127390


'/>"/>
SOURCE ImQuest BioSciences
Copyright©2014 PR Newswire.
All rights reserved

Related biology technology :

1. Cloud Pharmaceuticals Granted 1M Hours of Supercomputer Time to Target Orphan Diseases Including Malaria
2. Sunovion Pharmaceuticals Canada Inc. Announces Health Canada Approval of APTIOM(TM) (eslicarbazepine acetate) as a Once-Daily Adjunctive Treatment for Partial-Onset Seizures in Patients with Epilepsy
3. RXi Pharmaceuticals Receives US Notice of Allowance for a Key Patent Relating to its Self-Delivering Technology with sd-rxRNAs targeting CTGF, including RXI-109, for the Treatment of Fibrotic Disorders
4. Collaborations, FDA Approvals, Appointments, Patents, and Stock Movements - Research Report on Aetna, United Therapeutics, Perrigo, Arena Pharmaceuticals, and Keryx Biopharmaceuticals
5. Shimadzu’s New Aggregates Sizer Aggregation Analysis System for Biopharmaceuticals Enables Real-time Quantitative Analysis
6. Savient Receives Approval From Bankruptcy Court To Sell Substantially All Assets To Crealta Pharmaceuticals
7. Biotech Briefing: Advancing Biotechs Forging Ahead With Breaking News Developments: Alliqua, OncoMed Pharmaceuticals, EnteroMedics, Unilife, Amarin
8. Vanda Pharmaceuticals to Present at the 25th Annual Piper Jaffray Healthcare Conference
9. Actinium Pharmaceuticals Announces 2013 Annual Shareholder Meeting
10. Avanir Pharmaceuticals to Participate in Two Conferences in December
11. Jazz Pharmaceuticals Announces Participation at the Piper Jaffray Healthcare Conference on December 3
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... Dec. 2, 2016 CytRx Corporation (NASDAQ: ... specializing in oncology, today announced the appointment of ... industry consultant, and private healthcare investor, to its Board ... leader with clinical and strategic experience at the highest ... and CEO. "As one of the world,s leading orthopedic ...
(Date:12/2/2016)... ... December 01, 2016 , ... Aerocom Healthcare ( http://www.aerocomhealthcare.com ... will present its chain-of-custody solution for tracking and securing medications at booth 676 ... 4-8, 2016. , Aerocom has a proven solution for tracking medications via its ...
(Date:12/2/2016)... (PRWEB) , ... December 01, 2016 , ... ... congratulate long-term client Nanowear on their recent FDA Class II 510(k) clearance for ... a significant hurdle in commercializing remote cardiac monitoring devices that rely on cloth-based ...
(Date:12/2/2016)... , December 2, 2016 The immunohistochemistry ... growing at a CAGR of 7.3% during the forecast period of ... and diagnostic laboratories segment accounted for the largest share of immunohistochemistry ... ... on global immunohistochemistry (IHC) market spread across 225 pages, profiling 10 ...
Breaking Biology Technology:
(Date:6/21/2016)... , June 21, 2016 NuData ... the new role of principal product architect and ... the director of customer development. Both will report ... technical officer. The moves reflect NuData,s strategic growth ... response to high customer demand and customer focus ...
(Date:6/9/2016)... an innovation leader in attendance control systems is proud to announce the introduction of ... make sure the right employees are actually signing in, and to even control the ... ... ... ...
(Date:6/2/2016)... 2, 2016 The Department of Transport ... the 44 million US Dollar project, for the , ... including Personalization, Enrolment, and IT Infrastructure , to ... production and implementation of Identity Management Solutions. Numerous renowned international ... Decatur was selected for the most compliant ...
Breaking Biology News(10 mins):