November 17, 2016
The long-acting, nonhormonal contraceptive -- for men.
Scientific study of Vasalgel accepted for publication
Second paper -- reversal in rabbits -- submitted for review
Rhesus Monkey in tree
Monkeys are smart and social, and for humane reasons must be housed together. But how do you house male and female animals in social groups if you don't want more offspring? It's a perennial problem for zoos and research centers. (Right now people are trying to cut down on the number of primates used in research, not bring new animals into the system.) Vasalgel proved to be the answer for rhesus macaque monkeys at one National Primate Research Center .

Sixteen male monkeys received Vasalgel and were returned to their groups. The contraceptive worked great -- no babies were sired by these males. Vasalgel allowed the monkeys to enjoy a rich social life and provided benefits over vasectomy in terms of fewer complications. The results have been accepted for publication; keep your eye out in the coming weeks!

Equally exciting is the submission of Part Two of the Vasalgel study in rabbits. This study outlined how after a year of blocking sperm (study published earlier this year), the gel was successfully flushed out. Sperm flow returned almost immediately after the reversal procedure. (More recently we've been working to get these same results in larger animals.) The paper catalogs sperm functioning over time.

Stay tuned for announcements when these scientific results are published.
Two steps forward...
Recent test batch challenges scientists
pharmaceutical factory mixing tank
We've been happy to share our progress with you -- and so much has been accomplished this year! But we also have found that research sometimes leads to more questions than answers.

One area that has challenged us is that the last test batch of Vasalgel made earlier this year turned out to be too thick (viscous). This might sound like a simple issue, but with a complex SMA polymer, nothing is simple! We brought in a number of international polymer experts to help us understand what was going on and have conducted a number of tests over the past months. 

We think we've nailed down the issues, and have also learned a lot more about the complex chemical composition of Vasalgel in the meantime. The possible silver lining: We think the thicker recent batches may have something to do with the challenges in reproducing successful rabbit reversal results in larger animals, so sorting this out may solve a larger problem.

This work took time -- and has held up our ability to move forward with manufacturing, testing and preparation for the clinical trial. Thus the bad news: we won't be able to start enrolling clinical trial participants until 2017, rather than later this year as planned. For sure it won't start in the first half of the year. We are very unhappy about the delays -- we thought we'd be a lot further along by now -- but are looking forward to moving forward with a ramped-up team (see story below) hitting these issues on all fronts next year.

The good news is, we're still afloat. But as one of our biggest supporters reminded us, eventually if you don't reach shore, you drown! Watch for some faster swimming in 2017.
Ramping up, preparing for clinical trials
Medical device experts coming on board
Clinical Trial Men
This year we've been working to go from a scrappy team with its heart in the right place, to a team of experts in manufacturing, quality control, regulatory strategy and clinical trial implementation. 

One big success: The new manufacturing consultant got the Vasalgel social venture set up with a company that can successfully mix the thick gel and package/prepare it for use by clinicians. The team has also been comparing different regulatory pathways and creating our quality control program. We are grateful for the support of a major donor, which has allowed us to bring these experts on board. Look for further announcements in 2017 as we take Vasalgel development to the next level.
Give Vasalgel a boost on #GivingTuesday
On #GivingTuesday, November 29 -- a global day of giving -- we'll send you a message asking you to donate to speed the development of Vasalgel. If you're able to participate in the campaign, please do.

Are you in a position to put up a matching gift? This could incentivize donors and boost the success of our #GivingTuesday campaign. Contact to discuss.
We're working hard and are grateful for your support!

the Vasalgelâ„¢ team

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