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May 30, 2014
Vasalgel preclinical studies update
The new baboon mating study plan is just about complete, and we have started the process of selecting males for this study. Since the main goal is to show that the baboons do not impregnate a female after they have received Vasalgel™, we need to be sure that all of them are capable of fathering offspring. We have found a small number of males who have fathered offspring previously ("proven breeders") and are hoping to enroll them in the study. If we can do this, it would save almost a month on the study timeline and a lot of expense since we won't have to go through the process of putting males with females first to ensure pre-Vasalgel fertility. We are also investigating methods to visualize the placement of Vasalgel, which is a clear fluid that does not show up with standard imaging techniques. Micro-materials that show up on x-ray or ultrasound are often used for this purpose, and we are investigating whether they would be useful in the baboon study.

Timeline
Reversals for the first set of baboons should be next month. We're still looking at the baboon study being finished later this year, first small clinical trial starting next year, and a large, multi-site trial starting next year or early 2016.

Want more details? See the Vasalgel FAQ.

Animal welfare
We have written about our policies and standards on animal welfare in the past. This issue is incredibly important to Parsemus Foundation (the organization that supports Vasalgel's development). Did you know that Parsemus has a history of support for animal welfare projects? Parsemus Foundation has supported spay/neuter/rescue programs; is spreading the word about an ovary-sparing spay technique that lets female dogs keep the benefit of their hormones; has funded studies to advance a nonsurgical pet neuter technique that could spare cats and dogs from surgery, save shelters and rescue organizations millions of dollars per year, and potentially replace inhumane and primitive farm castration techniques; is a member of Animal Grantmakers and a Council of Stakeholders Visionary Circle supporter of the Alliance for Contraception in Cats and Dogs; and has a study about to be published about a simple treatment for canine-- and human-- prostatic hyperplasia.

Recently a concerned animal rights activist posting on Vasalgel's Facebook page made allegations regarding the welfare of animals used in our preclinical studies, so we thought it was a good time to expand on our past information and inform everyone waiting for Vasalgel about how we are addressing the welfare of the laboratory animals used in studies.

Why do we use animals in preclinical studies? Simply put, we have no choice. There are no non-animal alternatives to test Vasalgel. To obtain permission from regulators to begin clinical trials, we must prove that Vasalgel is safe. While many of the tests on the contraceptive are done at the lab bench, a few must be performed in animal models. Luckily, science is advancing at a rapid pace and non-animal alternatives are being developed every day. (Want to help support this research? Join us in supporting the Johns Hopkins Center for Alternatives to Animal Testing.) In addition, scientists are finding ways to test products more safely in humans too. We look forward to the day when animals are not required - but for today we must deal with this reality.

Parsemus requires strict adherence to animal welfare practices and uses the European standards, which are higher than the U.S. standards. For example, standard housing for primates is larger group enclosures - not little individual cages like are permissible in the U.S. Primates need to be able to move about freely, groom each other, and have social interactions. Our hope is that Parsemus Foundation can serve as a model to encourage other universities, companies, and funders to also voluntarily require higher living standards for laboratory animals, thereby making improvements "from within" while U.S. regulations catch up with other countries. We've already seen these requirements open minds at universities and facilities. For example, the rabbit facility added an exercise and socialization area for our study, and now that they've seen it's possible, they use it with other rabbits too.
The baboons live in social groups in a large enclosure
Vasalgel is being tested in the smallest number of animals possible while still ensuring reliable data. The rabbits and the baboons have been used to test the efficacy of the Vasalgel to create a durable and rapid-onset azoospermia (no live sperm) and to test the reversal (return of sperm). As you know, our results so far in rabbits have been terrific, while the baboon studies are still ongoing. The rabbit study recently concluded, and because the study had several delays and we tracked return of sperm for much longer than planned, the male rabbits became quite old during the course of the study. Because the veterinarian determined that they would not live much longer, after much discussion, they were humanely euthanized. Another factor: It seemed important to gather basic safety data in these rabbits that had Vasalgel for a good part of their lifespan (equivalent to decades of a man's life), since the goal is to have a first clinical trial in men next year, and this will be the last opportunity to gather such long-term safety data. (The baboon study will be "non-terminal"-- they will go back to their regular lives after the study-- so it won't provide that kind of information.) We hope you agree with us that men waiting for Vasalgel would want that safety data.

There are three females in the project that were used only as "teasers" to obtain semen samples from the males. (Basically, excite the males while the males mounted an artificial v-gina.) We originally planned to adopt them out, but the since they were also old, we were concerned that the stress of the move might negatively impact their health. Earlier this month we decided the best thing, all considered, would be to move them to a study of a treatment for heart problems in older women that needed older rabbits, which are hard to find. We thought we were doing the best thing, since shelters are overrun with rabbits and each one we put into the system takes a spot from a younger, more adoptable animal. But the activists reminded us of another perspective: It's hard to know what is best in the big picture, but at least for these three rabbits, we can make sure they can live out the rest of their lives in a happy situation, in accordance with our promise to adopt out as many animals as possible. Thus, the three older female rabbits will be leaving the lab behind and spending their remaining days at a sanctuary, which an animal sanctuary organization is helping us arrange.

Want to learn more about different ways of viewing animal ethics? Check out the Animal Ethics Dilemma interactive tool and summaries.

What about the baboons? The male baboons in our project are living in very large, outdoor enclosures with other baboons (see photo above). Baboons are intelligent and highly social animals that develop close relationships with other baboons. They are only brought into the hospital to obtain the Vasalgel implant and then returned to their social group. The baboons that will take part in the new mating study will be moved to a small group with females and will continue living in the same type of large, outdoor enclosures. The baboons will not be killed at the end of the study, but will simply live out their lives in their social group.

Parsemus Foundation has set many processes in place to safeguard the welfare of the animals used in the preclinical studies of Vasalgel. We hope that this description helps to set the record straight and assure everyone supporting Vasalgel of our focus on animal health and welfare.

Read more:
* "How to improve housing conditions of laboratory animals"
   (recent review article with pictures, PDF)
* Parsemus Foundation's research requirements and
   resources page for animal welfare

Ready to make a difference?
Join us in supporting the Johns Hopkins Center for Alternatives to Animal Testing. [online donation form] If you want, you can make your gift in honor of Vasalgel, or your favorite animal. (We'd love to hear if you read all the way through this and were inspired to donate; you can just hit "reply" to this email to let us know!)
We're working hard and are proud to have your support. More questions? Check out our FAQ or join us on Facebook.

Sincerely,
The Vasalgel™ team


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