Tuesday, March 11, 2008

IPM - Please explain the denial of rectal microbicides!

I share this press release - below - from IPM about a new license they now have from Merck to develop an antiretroviral for use as a microbicide. Of course, this is good news.

HOWEVER…. I think it is high time for IPM to speak to WHY they refuse to work on the research and development of rectal microbicides, and why they fail to even mention their existence.

In my view, as chair of IRMA, both this refusal and denial are unacceptable.

As you will see below, their definition of microbicides goes like this – “Microbicides are products, such as gels or films, that could be applied vaginally to prevent HIV transmission during vaginal intercourse”

Oh really? Microbicides are only for vaginal application? REALLY? Then, just what were all those presentations at Microbicides 2008 about which focused on rectal microbicide research and development? What did the 100+ scientists and advocates from around the world who attended a half-day symposium at M2008 on rectal microbicide development talk about for four hours?

”In the past two years the number of women living with HIV globally has increased by 1 million to 15.4 million. By the end of 2006, women comprised nearly half of the adults living with HIV and AIDS globally, but in sub-Saharan Africa, women and girls already account for almost 61 percent of people living with HIV,” says IPM in their press release.

If IPM were TRULY interested in serving women, they would stop denying that large numbers of women engage in unprotected anal intercourse across the globe, which puts them at greater risk for HIV acquisition compared to unprotected vaginal intercourse. Of course, there are also vulnerable men everywhere who are engaging in unprotected anal intercourse and need expanded prevention options as well. In the Western world, gay and MSM bear the brunt of the HIV epidemic, and they likely play a bigger role in the incidence and prevalence of HIV in the developing world than many of us understand or acknowledge. Why are they completely dismissed?

It is HIGH time for IPM, with its vast funding, to diversify its R&D portfolio and include projects to develop safe, effective and acceptable rectal microbicides.

Jim Pickett
Chair, IRMA

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Microbicide Developer Receives License for Novel

HIV Microbicide Candidate from Merck & Co., Inc.

IPM: Steve Taravella, staravella@ipm-microbicides.org, +1-301-608-2221, ext. 188

Merck: Ian McConnell, ian_mcconnell@merck.com, +1-908-423-3046

SILVER SPRING, Md. (March 11, 2008) — In a boost to HIV prevention research, Merck & Co., Inc., has agreed to provide a royalty-free license to the non-profit International Partnership for Microbicides (IPM) to develop a novel antiretroviral compound for use as a potential vaginal microbicide.

The compound, called L’644, is a member of a class of antiretroviral molecules known as gp41 fusion inhibitors, which inhibit HIV infection by preventing the virus from fusing with the surface of target cells, an early step in the HIV infection process, potentially representing a novel way to block infection.

This announcement follows a similar agreement with Merck that granted IPM a royalty-free license in 2005 to develop another compound, L’167/CMPD167, which belongs to the class of molecules known as CCR5 blockers.

Microbicides are products, such as gels or films, that could be applied vaginally to prevent HIV transmission during vaginal intercourse. IPM is also developing other delivery methods, such as long-lasting vaginal rings that would release the drug gradually over time.

“Merck deserves recognition for its exemplary commitment to HIV prevention research,” says Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides. “This arrangement for L’644 helps IPM pursue development of compounds that target HIV at many points in the virus’s lifecycle. We’re working toward the day when millions of women around the world will have access to safe and effective microbicides — and partnerships like this will help us get there.”

Preclinical research conducted by Merck suggests that L’644 is a potent HIV fusion inhibitor that is able to block infection of T cell targets in laboratory settings. For this reason there is a strong scientific rationale for evaluating its potential as an anti-HIV microbicide. Under the terms of the agreement, Merck grants IPM full royalty-free rights to develop L’644 as a microbicide to prevent HIV infection in women in developing countries, while also collaborating with IPM to advance early stage product development research efforts.

“Merck is pleased to contribute the results of our research and development to this worldwide effort to protect women from HIV infection,” said Dr. Daria Hazuda, vice president of scientific affairs for infectious disease and HIV at Merck Research Laboratories. “This agreement underscores our long-standing and ongoing commitment to finding new ways to prevent and treat HIV and AIDS.”

Collaborating with industry to secure promising compounds is a crucial first step toward making a microbicide accessible to those who most need it. Ensuring access is an essential element of IPM’s mission — and a guiding principle throughout its development process.

To that end, IPM has obtained royalty-free licenses for five antiretroviral compounds from pharmaceutical companies via agreements that have become a model for public-private partnership in fostering global health solutions. These non-exclusive agreements provide IPM flexibility in pursuing development and promoting access, which will allow it to make any resulting microbicide available in developing countries — including those where the impact of the AIDS pandemic has been most severe.

In addition to Merck, IPM’s pharmaceutical partners include Pfizer, which in January 2008 agreed to allow IPM to develop the CCR5 blocker maraviroc as a microbicide. In December 2006, IPM and CONRAD reached independent agreements with Gilead Sciences to develop tenofovir (PMPA), a nucleoside reverse transcriptase inhibitor. In October 2005, IPM entered agreements with Merck and Bristol-Myers Squibb to develop CCR5 blocker and entry inhibitor compounds early in development. In March 2004, IPM signed an agreement with Johnson & Johnson subsidiary Tibotec Pharmaceuticals to develop the company’s non-nucleoside reverse transcriptase inhibitor, dapivirine, as a microbicide; IPM expects to put that compound into a Phase III clinical trial late in 2009.

Safe and effective microbicides could provide women in the developing world with a powerful new tool to protect themselves from HIV that would complement existing prevention methods. In the past two years the number of women living with HIV globally has increased by 1 million to 15.4 million. By the end of 2006, women comprised nearly half of the adults living with HIV and AIDS globally, but in sub-Saharan Africa, women and girls already account for almost 61 percent of people living with HIV.

# # #

About IPM: The International Partnership for Microbicides was established in 2002 to accelerate the development and accessibility of microbicides to prevent HIV transmission in women. By screening compounds, designing optimal formulations, establishing manufacturing capacity, developing trial sites and conducting clinical trials, IPM works to improve the efficiency of all efforts to develop and deliver safe and effective microbicides as soon as possible. IPM’s donors include the governments of Belgium, Canada, Denmark, France, Germany, Ireland, the Netherlands, Norway, Sweden, the United Kingdom and the United States, as well as the European Commission, the Rockefeller and Bill & Melinda Gates Foundations, UNFPA, and the World Bank.

www.ipm-microbicides.org

1 comment:

Jim from IRMA said...

Here is the reply, sent to IRMA's listserv, from IPM

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Jim:



Thanks for giving the International Partnership for Microbicides a chance to discuss our organization’s focus again (“IPM — Please Explain,” March 11).



First, we agree that more research must take place on rectal microbicides, both for male and female use.



We all know that the anatomy, physiology, histology and ecology of the rectum are very different from the vagina, and that the mechanisms of HIV transmission across rectal mucosa may differ from those across vagina tissue. Additional studies are required to address these differences as they relate to microbicide development. Even with current knowledge, we know that product development efforts for rectal microbicides will be different from efforts for vaginal products.



IPM was founded — and funded — specifically to accelerate the development and availability of vaginal microbicides. As part of this work, we will conduct safety trials to confirm that there are no adverse effects if a vaginal microbicide is used rectally, but our studies are not designed to determine whether the product prevents HIV infection when used this way.



We will continue to share findings, product, and field experience with rectal microbicide researchers, as we recognize the importance of their work. For example, we have provided UCLA with samples of dapivirine gel — one of IPM’s most advanced products — to analyze for in-vitro safety in monkeys and in explanted tissue, and we have agreed to manufacture placebo gel for use by UCLA in rectal imaging studies.



IPM believes proof of concept will be easier to demonstrate for vaginal microbicides and that the scientific gains made in the process will speed the development of products specifically for rectal use.



In your post, you raise a question about the way we define microbicides. When our news releases refer to microbicides as “products that could be applied vaginally,” we are merely describing the work that is the subject of the releases. We are in no way dismissing research on rectal products. It’s simply that rectal products have not been not the focus of these particular announcements. That said, your broader point about capturing the spectrum of work that’s taking place in the microbicide field is very important.



Another recent IRMA posting raised concerns about including HIV-positive women in clinical studies.



Positive women and advocates have expressed concern, understandably, that current clinical trials are not answering many questions they need answered — among them, whether their use of microbicides will protect their uninfected partners. Bi-directionality is an important issue that deserves greater study. But IPM’s focus at this point is on obtaining “proof of concept” that a vaginal product can protect uninfected women during intercourse.



Because IPM’s goal is to develop a microbicide to prevent transmission from infected men to uninfected women, any women who become infected with HIV during the trials cannot continue using the study product. This is the nature of clinical trials, and a responsible course of action.



At the same time, we recognize that positive women bring so much insight to the table that they must be consulted closely throughout the microbicide development process. This is one reason that IPM convened a series of conference calls last year among women living with HIV, scientists and clinical experts to discuss the role of HIV-positive women in microbicide research and clinical testing. A summary of these discussions is available on the website of the International Community of Women Living with HIV/AIDS at: http://www.icw.org/node/301



We are committed to continued collaboration with rectal researchers, HIV-positive women and others — because only by working together will we all finally see microbicide products available where they are needed most.



Steve Taravella

Director of Communication

International Partnership for Microbicides

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