Pharma

Doubling down on regenerative medicine: Juventas and SironRX

Many business professionals likely dream of the day when they’ll run a company as chief executive, but how many hope to lead two startups simultaneously? As CEO of Cleveland-based regenerative medicine startups Juventas Therapeutics and SironRX Therapeutics, Rahul Aras is doing just that. Each company is developing therapies based off the same technology, a growth […]

Many business professionals likely dream of the day when they’ll run a company as chief executive, but how many hope to lead two startups simultaneously?

As CEO of Cleveland-based regenerative medicine startups Juventas Therapeutics and SironRX Therapeutics, Rahul Aras is doing just that. Each company is developing therapies based off the same technology, a growth factor called JVS-100 that recruits stem cells from the bone marrow to create new blood vessels. The technology was pioneered by Dr. Marc Penn, medical director of the Cleveland Clinic’s cardiac intensive care unit. Penn is chief science officer with each company.

Juventas is focusing on cardiovascular disease, while SironRX aims to develop a wound-healing therapy. Juventas formed in 2007 under the name AcelleRX Therapeutics and has raised about $10.5 million in investment funding and grants. SironRX launched earlier this year with a $500,000 investment from Cleveland Clinic and venture development group JumpStart. SironRX expects to close a $2.5 million to $3 million round of investment soon.

Aras is the former director of life science commercialization with Cleveland Clinic Innovations, the group charged with turning discoveries by Cleveland Clinic doctors into marketable products. His background is in biomedical research and he holds a Ph.D. in the subject from New York University.

Aras spoke with MedCity News about how JVS-100 works, when each company might get a product on the market and a significant change he expects to see in the future of regenerative medicine.

Q: What’s the most challenging thing about serving as CEO of two companies?
A: Being CEO of just one company can be a challenge. With Juventas and SironRX, there are certain overlaps that allow for synergistic development between the two companies. Put another way, what’s good for one is good for the other. But at the end of the day, these are two entities with unique investor bases, and each one of those bases is uniquely focused on the return on their investment. It’s important for me to be able to facilitate the knowledge transfer and efficiency of operations that can occur by me being CEO of both versus the fact that they each need to be managed as standalone entities.

Q: Both companies are based on the same technology, called JVS-100. What is it and how does it work?
A: JVS-100 encodes for a molecule called Stromal Cell-Derived Factor-1 (SDF-1). It was discovered by Cleveland Clinic cardiologist, Marc Penn, as a naturally produced molecule that attempts to repair the heart immediately following a heart attack. We now know that it works to repair a broad range of organ systems following injury, including the heart, the vasculature, brain, kidney and skin.

It works through a few mechanisms. It recruits the body’s own stem cells to repair tissue, and it also prevents the death of existing cells while promoting blood flow that helps to provide nourishment to the organ. The unique thing about SDF-1 is that it appears to have potential to repair tissue in acute and chronic injury settings, suggesting, for example, that you can deliver it to the heart anytime following a heart attack and have the potential to promote some level of repair. On top of this, we believe that it may be exploited across a broad range of clinical indications.

Q: What is the single, most important next step for both Juventas and SironRX?
A: For Juventas, we’ve just completed a phase 1 clinical trial in heart failure. It demonstrated that the product is safe and we’re seeing encouraging signs of efficacy. Next step is that we’ll do a phase 2 trial for heart failure further evaluating potential efficacy. We also have FDA approval for a phase 2 trial in patients with critical limb ischemia.  This is a devastating disease in which approximately 30 percent of patients undergo a major amputation within one or two years of diagnosis.  We’ll be ready to start dosing patients in this trial as soon as early summer.

SironRX is at a similar stage in the field of dermal repair. We’re looking to initiate a phase 2 clinical trial in the areas of accelerating post-surgical wound closures and reducing the amount of scarring. Being able to further define human efficacy through these trials will be key for both companies.

Q: Any rough estimate of when each company might get a product to market?
A: We believe the path to commercialization for the wound-healing product may be a bit shorter, and we could have something on the market within the next three or four years. I wouldn’t say the path for heart failure and critical limb ischemia is that much longer, but we’re talking something more along the 2015 or 2016 time frame.

Q: How do you see the field of regenerative medicine changing over the next five to 10 years?
A: The field has evolved significantly in the last 10 years. We’re at a point where I believe people following the industry have an appreciation that regenerative medicine will play a significant role in how we treat a range of diseases in the future. Major corporations like Pfizer, Roche and Johnson & Johnson have created internal regenerative medicine programs and are actively forming collaborations with researchers and companies in the field.

While a key focus  for the field remains the need to demonstrate clinical efficacy through execution of large, well-designed clinical trials necessary to gain market approval, an equally important challenge is developing commercialization models for how regenerative medicine will be delivered to the general population in a cost-effective way.  In the future, the field will become more efficient in its product development and commercialization strategies.