September 12, 2010
www.conrad.org
 

CONRAD News

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Tenofovir (TFV) Updates

After 20 years of research, microbicide researchers tested a gel that significantly reduces a woman’s risk of becoming infected with HIV, as well as herpes. Tenofovir gel, licensed to CONRAD royalty free by Gilead Sciences, is a breakthrough for the field and we at CONRAD are proud to have put our efforts into providing the product for this important finding. We congratulate the excellent study team at CAPRISA in Durban, South Africa and FHI, thank USAID for their faith and funding, and applaud the 889 South African women who participated in the study and made this concept a reality.

Next Steps

Stakeholders in the HIV research and advocacy community met in Johannesburg at a meeting convened by WHO and UNAIDS to discuss next steps for tenofovir gel.  Participants agreed on a "roadmap" and details of additional studies were discussed over the three day meeting.   Although funding for additional trials is currently unresolved, CONRAD will continue to manufacture and supply tenofovir gel for the studies.  For more details on the UNAIDS statement, please click here.

TFV-based Gel Combinations and TFV-releasing Intravaginal Rings (IVRs)

While TFV showed efficacy alone in the CAPRISA trial, combining it with another microbicide could have additional benefits including increased effectiveness and reduced likelihood for the development of resistance. Research has shown that HIV can use multiple pathways to infect cells, therefore combining two microbicides with different mechanisms of action could increase protection against HIV infection. In addition, while the CAPRISA trial results did not show any TFV-related resistance in women who acquired HIV during the trial, combining TFV with another ARV would add another layer of protection against the development of resistance. It is for these reasons that CONRAD researchers are focusing intense efforts on formulating gels combining TFV with other microbicide candidates.

CONRAD is also developing a TFV releasing IVR design to provide continuous exposure to vaginal and ectocervical tissues for up to 90 days. The IVR is prepared from novel polyurethanes designed specifically for controlling release of TFV. The goal is to test this new IVR in a Phase 1 safety/pharmacokinetic clinical study in mid 2011.

MEETINGS

XVIII International AIDS Society, July 17-23, Vienna, Austria

Over 25,000 international delegates gathered in Vienna this summer at one of the most uplifting AIDS conferences in recent memory, thanks to the CAPRISA study results.  Thousands attended the oral presentation (many of whom were crammed into an overflow room) to give a standing ovation for co-investigators Salim and Quarraisha Abdool Karim and the study team.  Following the presentation, Salim, Quarraisha, Tony Fauci with NIAID, Robert Clay with USAID, Ward Cates with FHI and CONRAD's Henry Gabelnick spoke at the press conference, which was attended by hundreds of journalists, and engaged in a lively Q and A.  Dr. Gabelnick was also a featured speaker at the Global Campaign for Microbicide's symposium that evening.  

To view an interview with Dr. Gabelnick and FHI President Ward Cates, please click here.

For the final CAPRISA press release, fact sheet, FAQs, front page pdfs and the presentation, please go to: www.conrad.org.

Microbicides 2010, May 22-25, Pittsburgh, PA

This year’s Microbicides conference, entitled “Microbicides: Building Bridges in HIV Prevention,” brought together more than 1,000 participants from across the globe to share information on HIV prevention.

CONRAD Executive Director Henry Gabelnick Wins Lifetime Achievement Award

Before an audience of more than 1,000 HIV advocates and scientists, CONRAD Executive Director Henry Gabelnick, Ph.D. was recognized for his unparalleled commitment and dedication to the development of microbicides with the lifetime achievement award. This lifetime achievement award was his second—in 2005, Dr. Gabelnick was recognized by the International Conference on AIDS India for a lifetime devoted to reproductive health.

"In a field with so many dedicated, brilliant and persistent researchers, I am tremendously honored to be singled out by my peers," said Dr. Gabelnick. His acceptance speech described his early years working in the chemical industry and his journey to more fulfilling work in the field of contraception and microbicides. Dr. Gabelnick received his undergraduate and graduate degrees from MIT and his doctorate from Princeton. After beginning his career in the chemical industry, Dr. Gabelnick moved to the Biomedical Engineering Branch of the National Institutes of Health. He joined CONRAD at its inception in 1986, and focused primarily on developing new methods of contraception until it became clear that HIV prevention was crucial to overall reproductive health. For the past 20 years, CONRAD has contributed to the microbicide development field through the development of preclinical algorithms and primate models, standardization of colposcopy techniques, biomarker research and clinical trials.

CONRAD Presentations:

Assessing Markers of Inflammation after Vaginal Product Use: Nonoxynol-9, Cellulose Sulfate, and HEC Placebo Comparative Double-Blind Phase I Trial – Christine Mauck, M.D., M.P.H.

Colposcopy: Still Useful in Microbicide Safety Trials? – Christine Mauck, M.D., M.P.H.

Combining HIV Prevention and Contraception Technologies – Gustavo Doncel, M.D., Ph.D.

Evaluation of 6% Cellulose Sulfate and 0.5% PRO2000 Gel Microbicide Efficacy in a Single-Dose Intravaginal R5+X4 SHIV Infection Model in Rhesus Macaques Pre-treated with Depo-Provera – Mohammed Saifuddin, D.V.M., Ph.D.

Gene Expression Profile of Vaginal Epithelial Cells Exposed to Proinflammatory Agents – Identification of Novel Biomarkers of Mucosal Safety – Irina Zalenskaya, Ph.D.

Pilot Clinical Pharmacokinetic and Pharmacodynamic Study of UC781 Vaginal Gel – Jill Schwartz, M.D.

CONRAD Poster Presentation:

I. Major, D. Lowry, K. Malcolm, d. Woolfson, D. R. Friend, J. Cohen, P. LaBarre, Development of microbicide releasing SILCS diaphragm. Microbicides 2010, Pittsburgh, PA, Abstract No. 243, May 2010.


L. Ferguson, J. Cohen, J. Schubert, T. Gong, C. Dezzutti, D. Friend, L. C. Rohan, Vaginal delivery of UC781 in Woman’s Condom capsules. Microbicides 2010, Pittsburgh, PA, Abstract No. 248, May 2010.


C. McConville, D. Friend, D. Woolfson, K. Malcolm, Safety testing of silicone elastomer matrix vaginal rings containing UC781 and Tween 80 using Epivaginal (VEC-606) tissues. Microbicides 2010, Pittsburgh, PA, Abstract No. 238, May 2010.


J. Moss, M. Baum, A. Malone, D. Friend, E. Copin, S. Kennedy, C. Nyugen, J. Smith, C. Cortez, T. Smith, In vitro release of tenofovir and acyclovir from a silicone vaginal ring platform. Microbicides 2010, Pittsburgh, PA, Abstract No. 259, May 2010.


C. McConville, D. Friend, D. Woolfson, K. Malcolm, A two-compartment in vitro release model for the testing of HIV microbicide formulations. Microbicides 2010, Pittsburgh, PA, Abstract No. 234, May 2010.


L. Ferguson, C. Dezzutti, B. Moncla, M Parniak, L. Wang, D. Friend, and L. C. Rohan, UC781 polymeric thin films-Optimization and stability assessment. Microbicides 2010, Pittsburgh, PA, Abstract No. 230, May 2010.


L. Wang, C. Dezzutti, B. Moncla, M. Parniak, R. Mallipeddi, D. Friend, L. C. Rohan, Formulation of tenofovir containing a quick-dissolve film product. Microbicides 2010, Pittsburgh, PA, Abstract No. 236, May 2010.


E. A. Ho, A. Tuitupou, H. Elgendy, M. R. Clark, D. R. Friend, P. F. Kiser, A polyurethane intravaginal ring for the delivery of UC781. Microbicides 2010, Pittsburgh, PA, Abstract No. 240, May 2010.


J. Clark, U. Nagaraja, A. Tuitupou, E. Ho, M. Clark, D. Friend, P. Kiser, Sustained delivery of tenofovir from polyurethane intravaginal rings. Microbicides 2010, Pittsburgh, PA, Abstract No. 242, May 2010.


F. R. Damian, J. Fabian, M. R. Clark, H. Elgendy, G. F. Doncel, D. R. Friend, T. McCormick, P. F. Kiser, Preclinical stability and excipient compatibility leading to the development of combination gel formulations of UC781 and tenofovir. Microbicides 2010, Pittsburgh, PA, Abstract No. 249, May 2010.


A. Mahalingam, E. Smith, J. Fabian, F. R. Damian, J. J. Peters, H. Elgendy, M.R. Clark, D. R. Friend, D. F. Katz, P. F. Kiser, Rational design of a vaginal microbicide gel: Relating composition to properties and performance. Microbicides 2010, Pittsburgh, PA, Abstract No. 469, May 2010.


D. F. Katz, J. Peters, M. Clark, D. Friend, Multivariate computational model to help rate microbicide gel performance combining vaginal distribution, drug delivery, and acceptability, Microbicides 2010, Pittsburgh, PA, Abstract No. 183, May 2010.


F. R. Damian, E. A. Ho, M. R. Clark, D. R Friend, P.A. Kiser, Dual protection polyurethane intravaginal rings for the simultaneous delivery of levonorgestrel and UC781, Microbicides 2010, Pittsburgh, PA, Abstract No. 226, May 2010.
McCormick, Ph.D.

For more information on CONRAD presentations at Microbicides 2010, please click here.

Dr. Michael Harper, Director of the Consortium for Industrial Collaboration in Contraceptive Research (CICCR), Retires After 15 Years with CONRAD

Dr. Michael Harper, who served as Director of the CICCR for 15 years, retired on June 30, 2010. Upon his retirement, Eastern Virginia Medical School granted Dr. Harper the title of Professor Emeritus. Dr. Harper joined CONRAD in 1995 to lead the CICCR, which was established to help revitalize the pharmaceutical industry’s commitment to developing new contraceptives. The CICCR was the first such public-private drug development partnership established. During the past 15 years, the CICCR received both public and private support totaling more than $39 million; these funds have been used to support the research and development of contraceptive methods that specifically address the needs and perspectives of women, with particular emphasis on three priority areas: male methods, monthly methods for women, and vaginal methods that prevent both pregnancy and sexually transmitted infections (STIs). Reflecting on his 15 years leading the CICCR, Dr. Harper said that he was proud of the progress made in the pursuit of novel male and female contraceptive leads and excited about meloxicam’s potential as a nonsteroidal contraceptive, both as emergency contraception and as a monthly birth control regimen.

For the past 15 years, Dr. Harper has commuted weekly between his home in Sugar Land, Texas and CONRAD’s offices in Arlington, Virginia. He said that he will not miss the commute and looks forward to spending more time with his wife, Ann. While he does not have any specific plans for retirement, Dr. Harper said that he will continue to keep abreast of the latest contraceptive developments. Despite officially retiring on June 30, 2010, Dr. Harper attended the annual meeting of the Society for the Study of Reproduction held in Milwaukee, Wisconsin July 30-August 3, 2010.