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May, 2014

Matching challenge also results in major contribution to Vasalgel development

Over 1700 gifts have been received to help fund the baboon study over the past six months, resulting in a total of $64,354 in donations. A special "Thanks" to everyone who has participated in the matching challenge so far! Your donation was doubled by an anonymous donor, who recently contributed $22,326 to help move Vasalgel™ to market. The challenge started on January 31st and resulted in many supporters being able to make twice the impact for Vasalgel. The matching gift allows the Vasalgel science team to also work on setting up the synthesis, testing and manufacturing of the contraceptive - steps needed to get it to market.



For those of you who donated $20 or more, we hope you like your Vasalgel stickers - a small token of our appreciation for your support! We will continue to send them out as long as supplies last. If you did not get yours - and you donated $20 or more this year - please send your name and mailing address to info@parsemusfoundation.org.







Monkey trouble

Everyone is wondering what is going on with the baboon study - the final animal research prior to clinical trials of Vasalgel. The science team has been hard at work analyzing the data obtained since the seven baboons were implanted with Vasalgel. First the good news: The baboons are all healthy and happy - the most important factor from a regulatory standpoint! But now the not-so-good news: there's a glitch.



Three of the baboons had beautiful sperm numbers quickly - i.e. almost no sperm - and most of the other baboons' sperm numbers seemed to be dropping nicely. But just when we were getting ready to celebrate, several of the baboons' sperm numbers bounced back up! What the heck?!



You can bet it's been a stressful time around here. A lot is riding on this study. But after weeks of analysis and testing, we think we know what's going on. The method of collecting the semen likely dislodged the Vasalgel!



It turns out you can't just ask the male baboon to offer up a semen specimen for analysis. (The rabbits in the rabbit study were much more obliging, all it took was a "teaser" female nearby to get them in the mood ... ) To obtain the semen, the veterinarian uses a procedure called electroejaculation. A device with mild electric currents stimulates the nerves near the prostate gland, which creates contraction of nearby muscles - and ejaculation. This procedure is fairly commonly used in primates and other mammals - and humans with spinal cord injuries or other ejaculatory dysfunctions. However, it's different than a regular climax, and we think the electrical stimulation and intense contractions moved the Vasalgel within the vas deferens enough for it to lose effectiveness, especially since similar stimulation was one part of an elaborate four-part technique to intentionally remove another type of polymer contraceptive (RISUG�, the contraceptive being developed in India that first inspired us to get into this field and look for a cost-effective approach that could make it through FDA requirements). Photo credit: www.iastate.edu What are we going to do now? The Vasalgel science team has already developed a plan. The first thing we did was to STOP all sperm testing to avoid dislodging anything more. Then for the three baboons that are still azoospermic (no live sperm), we will stick with the original plan to reverse/flush out the Vasalgel a few weeks from now, to test that the reversal procedure works well and that sperm flow is quickly restored. Meanwhile, we are adding another group of four baboons. First they'll be screened for fertility (they'll have about three weeks to mate with 3-5 fertile females to show they have what it takes!). Then once they're proven fertile, they'll get Vasalgel, rest up a few weeks, and go back with fertile females. After that, they should not produce offspring. A simple solution to the problem - and one we are guessing the male baboons will enjoy a lot more! This new mating study will take a bit more time and be more expensive, but the overall goal to complete the study by the end of the year should be met.



Timeline

It would be a lot simpler if Vasalgel could go straight to clinical trials - lots of men would be eager to help! But there is no way around these safety studies--and it's better to be working out the kinks now.



The good news is that between the rabbit study and this baboon study, there is more and more evidence of safety. The bad news is that with the inevitable delays of science, we're looking at a first clinical trial next year, not this year.



What can you do? Wish us luck, send good thoughts, and cross your fingers. We should be okay from a money standpoint if we can resolve these questions quickly and get better baboon results from a mating study. We just need our supporters to stick with us. If the sperm sampling method is the problem and we can resolve it, it will be full steam ahead! We won't be fundraising until we're sure we're back on track. Stay tuned...

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



