Start-ups in male contraception: A status report
Every few years, academic researchers (and in the past, major pharma companies) have come together at the NIH's "Future of Male Contraception" conference to compare notes. But what's going on outside academia, in the world of start-ups? Surprisingly, more than half a dozen companies are trying to make it in the world of new male contraception! Many are struggling, and we suspect that with the current economic retrenchment, that number will be halved by a year or two from now if there isn't a fresh infusion of funding.
A 2006 external review of the government contraceptive research program at USAID reports that "these types of companies would need additional expertise in cGMP manufacturing, registration, distribution, and marketing to complete the product development process of an acceptable drug candidate... While their size and access to venture capital allows them to undertake more risky projects, they lack the staying power to overcome long delays or setbacks in developing a product candidate." This creates an opening for government and foundation funders who want promises of affordable public-sector pricing (in exchange for an infusion of cash) and legal teams savvy enough to make that happen. This win-win arrangement would keep the companies alive long enough to reach market, while making sure their products benefit more than a select few.
Here’s a roster of today’s male contraceptive start-ups, starting with those closest to market:
Product: Pro-Vas implantable clip
Company: Florida-based MenRx Surgical
Status: This company is well on its way to market with another vasectomy alternative, the Pro-Vas implantable vas-occlusive clip. The clip would be used in conjunction with no-scalpel vasectomy to close the vas slightly more quickly and, it is hoped, with less tissue damage than standard ligation and excision. However, like the Vasclip before it, Pro-Vas has been approved under theFDA's 510(k) rule as equivalent to a device already on the market for another use in terms of safety and biocompatibility. Under this program, there is little reporting of efficacy required. The Vasclip, for example, no longer appears to be on the market, after substantial failure rates were reported by physicians, users, and in the medical literature. Researchers found that though the clip could be correctly positioned, sperm formed new channels through the process of scar tissue and spermatic granulomas. This is the primary cause of vasectomy failure in the other methods in regular use, and the reason best practice combines cautery and the fascial interposition techniques [link: http://www.infoforhealth.org/pr/d6/d6.pdf ]. The Pro-Vas incorporates design improvements that may make it more effective than the Vasclip; if a clip design can be effective in vasectomy as it is in female tubal ligation, this would seem to be as promising a design as any. The key change is that the device has a spring clip that should allow varying vas diameters to be effectively ligated while not damaging the underlying tissue’s blood flow. Product release is scheduled for November, at which time the company will look for physicians to participate in an efficacy trial.Product: SpermCheck home sperm count kit
Company: Virginia-based ContraVac
Status: The company’s SpermCheck Vasectomy is an over-the-counter test with a much lower threshold than the commonly-available sperm count tests. It gained FDA approval last March, and the kit was to be available by the end of this summer but apears to be delayed. In addition to allowing at-home confirmation of vasectomy success, the test will be useful for men using DIY heat-based methods of contraception. ContraVac is seeking additional financing in order to begin a sales and marketing campaign for the device.Product: Intra Vas Device (IVD)
Company: Minnesota-based Shepherd Medical Company
Status: Presented promising Phase I clinical trial 6-month interim results at last year's Future of Male Contraception conference. The company learned several lessons from the initial study of this removable vas deferens plug, and planned to run a new study with a refined insertion procedure to increase the 92% success rate. However, the company did not win a second NIH grant, despite a high score on its application. A company representative now says there is “nothing to report” clinically or structurally. Is it possible that the company has not found enough other funding to continue operations and conduct further studies in the U.S. and Canada as planned?Product: HIFU non-surgical vasectomy
Company: California-based Vitality Medical Products, LLC
Status: High-intensity focused ultrasound (HIFU) has been tested as a way to nonsurgically close the vas deferens for permanent contraception. For HIFU sterilization, a small ultrasound transducer is clamped around the vas deferens and the scrotal skin. Proof-of-concept studies carried out at the Johns Hopkins Medical Institute with dogs have established the proper power level and length of time needed to permanently occlude the vas (about 40-60 seconds), using equipment supplied by a company that sells HIFU equipment for treating heart defects. The developer of the technology founded the start-up company a few years ago to test and commercialize the non-invasive sterilization method. Funding was not forthcoming, however, and the project has been dropped barring new investment.Product: Vassonic device
Company: California-based Vassonic
Status: This company has taken advantage of advances in miniaturized energy storage and delivery to design an implantable ring-shaped device intended to kill sperm passing through the vas deferens. The device, which encircles the vas, is intended to render sperm permanently immotile without obstructing sperm flow, thus avoiding many of the potential side effects of occlusive devices. The device is designed to be non-invasively activated or deactivated by a healthcare professional, much like a pacemaker is adjusted. The company is being tight-lipped about the technological details until hearing back on its patent applications. In this era of shrinking government science budgets, a first NIH grant submission did not result in funding, so the company will be looking for private funding sources as well as other grant submissions to finish feasibility studies on the device.Product: Non-occlusive vas device
Company: Canadian-based, but not yet named
Status: A team including Ron Weiss, a Canadian vasectomy expert who also participated in the WHO evaluation of RISUG facilities in 2002, is working on a non-occlusive, reversible vas-based device that is still under secrecy but is reportedly “redefining the field without re-inventing the wheel.” Rodent tests are scheduled to begin this calendar year, and the startup is looking for funding.Product: Selective Androgen Receptor Modulators (SARMs)
Company: Tennessee-based GTx
Status: The company is conducting a Phase IIb clinical trial evaluating Ostarine™, its lead SARM, for the treatment of cancer cachexia, the severe muscle loss associated with many cancers. The Phase IIb cancer cachexia trial is a randomized, double blind, placebo controlled study of muscle wasting in 150 patients with non-small cell lung cancer, colorectal cancer, non-Hodgkin's lymphoma, or breast cancer. GTx anticipates results from the trial in the third quarter of 2008. GTx and Merck have formed a global strategic collaboration for SARMS. Though GTx is concentrating on the profitable (and less politically fraught) cancer market, this SARM could potentially be used as an oral male contraceptive, possibly with an improved side effect profile compared to other currently available forms of testosterone.Product: Sperm-specific flagellar motility blockers
Company: Norwegian biotech Spermatech
Status: The company is looking for a drug to directly target a sperm protein discovered by University of Massachusetts Medical School researcher Dr. George Witman. The company has gathered all the intellectual property related to this sperm-specific protein under one roof, avoiding protracted patent fights and giving this approach its best chance at success. Spermatech recently partnered to move forward with high-throughput screening (HTS) for compounds that affect “sperm motility in general,” and in vitro tests of synthesized peptides for their target protein. They will seek additional funding, both grants and equity investments, early next year to cover the costs of reaching the clinical Phase I milestone.Product: CatSper ion channel blockers
Company: Massachusetts-based Hydra Biosciences
Status: Continuing to search for larger partners interested in helping the company use high-throughput screening to look for a drug to block sperm-specific CatSper ion channels. The CatSpers are crucial players in sperm hyperactivation, discovered by company co-founder and Harvard researcher Dr. David Clapham and his team.
