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Spring 2013
Success! Twelve Rabbits,
Six Months, No Sperm

Yesterday the 12th of 12 rabbits marked six months with Vasalgel™, the long-acting non-hormonal male contraceptive -- with no sperm at all since the second semen sampling!

We were nervous about this study, because it's crucial in determining whether the technology transfer from India went right. Does the new version of the gel (Vasalgel™) work as well as RISUG� in India? Did we successfully adapt the technology for production on a larger scale? It looks like we pulled it off -- so we're breathing a sigh of relief!
Next Steps
Some of the rabbits will now have the Vasalgel reversed by flushing it out with another injection; we're looking into adoption for them for afterwards. (We also require animal housing to meet the much stricter and more humane new European standards; for more information on why the European standards are better than the U.S. ones and what we're doing to try to create change within the system, see the FAQ section.)

At the same time there's a flurry of planning: Our small team is choosing manufacturing sites, figuring out final issues around syringe filling and sterilization, looking for a facility that can do a monkey study to our housing standards and within budget, preparing to talk with the FDA, and more.
Timeline to Clinical Trials
We are still aiming to start the first clinical trial by the end of this year, and to have Vasalgel to market by the end of 2015. (It'll be tight -- that's less than 3 years!) Some milestones:
  • Starting monkey study, and talking to FDA:
    Next couple months
  • Crowdfunding: late spring (probably May)
  • Knowing more about clinical trial eligibility:
    Summer or fall
  • Starting first small clinical trial (about 50 people):
    End of year
  • Reversibility study and second, larger clinical trial:
    Next year
Note: The first clinical trials are likely to be only open to men who are finished having children, since the reversibility studies haven't been done yet. (So far reversibility has only been studied in animals and a handful of men with RISUG in India-- we're just starting reversibility studies of Vasalgel™.) Realistically, for most men it's going to be at least 2-3 years before Vasalgel™ is an option. Getting frustrated with current methods? Check out the Male Contraception Information Project's page about least-bad current options while you wait.
Finally: A Way to Support Development
People have been asking -- and demanding! -- to contribute for a while now.  But we didn't want to take contributions until we were sure we were on the right track. Well, now we're pretty darn sure!

Parsemus Foundation (the nonprofit foundation developing Vasalgel) has set up Vasalgel as a "social venture," so that the contraceptive will be affordable rather than at big-pharma prices. But that means we don't have big-pharma resources! Here are some of the bills coming up we are raising money for:
  • Reversal branch of the rabbit study: $10,000 - $12,000
  • Production and manufacturing: ~$120,000
  • Toxicology (safety) studies:  $110,000 - $150,000
  • Monkey effectiveness study: ~$120,000
  • Initial human study, about 50 men: $150,000 - $250,000
  • Pivotal human trial: $500,000 to multi-million, depending on the number of sites and the number of men who get to take part
We'll be relying on public support to get this to market. Will you help us get to the next step, clinical trials?

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We're working diligently and are thankful for your support!

Sincerely,

The Vasalgel™ team  


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