BioWorld Today Contributing Writer

SironRX Therapeutics Inc., a regenerative medicine spinoff from the Cleveland Clinic that is developing a topical therapy to accelerate dermal and bone healing and decrease scar formation, closed a $3.4 million Series A investment. The company plans to use the funds to begin clinical trials of its wound therapy technology and to build its senior management and clinical team, according to Rahul Aras, the company's co-founder, president and CEO.

The financing, which exceeded SironRX's goal of $3 million, was led by North Coast Angel Fund. Additional investors were largely based in Ohio – including the Cleveland Clinic, JumpStart Inc., Glengary LLC, Ohio Tech Angel Fund III, Early Stage Partners and X Gen Ltd. – and were joined by Fletcher Spaght Investments of Boston.

In February, SironRX secured a combined $500,000 commitment from JumpStart Ventures and the Cleveland Clinic.

Cleveland-based SironRX in-licensed its lead drug, JVS-100, for dermal and bone repair from Juventas Therapeutics Inc. The sister Cleveland Clinic spinoff is pursuing its own treatment of JVS-100 for cardiovascular disease. Aras serves as CEO of both companies. (See BioWorld Today, April 7, 2010.)

JVS-100 contains an engineered version of stromal cell-derived factor 1 (SDF-1), a naturally occurring factor that activates the body's repair processes.

Juventas has completed a Phase I trial demonstrating safety and preliminary efficacy in Class III heart failure patients.

While Juventas is focused on cardiovascular applications, the JVS-100 technology has demonstrated preliminary efficacy in many other tissue types, including the skin, kidneys and brain. Thus, other indications, such as diabetes, loom as large opportunities.

The obvious question is whether the sister companies both can survive and thrive on the basis of a single technology. "The key is that the product SironRX is developing is a very different formulation," Aras explained. "Juventas is delivering an injectable form of SDF-1, and SironRX will deliver a topically delivered form. That differentiation allows the two companies to exist in a noncompetitive way and develop products for very different markets."

SironRX plans to begin a clinical trial early next year to evaluate the safety and efficacy of JVS-100 in patients who have undergone a median sternotomy, a procedure commonly used in coronary artery bypass and valve replacement surgeries. The placebo-controlled, randomized, dose-escalation trial will seek to evaluate the safety and efficacy of SironRX's technology in accelerating wound healing and reducing scar formation in median sternotomy patients.

The Series A round is sufficient to see the company through that study, which should report data in late 2012 or early 2013, Aras told BioWorld Today. An FDA filing is planned for early 2012.

Long term, SironRX's technology has additional potential to address a broader spectrum of dermal- and bone-related clinical indications, including burns, chronic wounds and fractures, according to Aras. With the potential to expand its base and treat a broad cross-section of clinical indications, SironRX is keeping its options open about whether to build its own standalone teams or seek partnering deals. "We're obviously hoping to look at both scenarios," he said.

Launched last fall, SironRX is the latest in a string of biotechs pinning their futures on the potential to deliver potentially life-changing regenerative therapies. Excitement in the field has generated significant partnering and investment activity this year. Privately held NeoStem Inc., of New York, recently expanded its line of cell therapy businesses – which include early stage research, storage, manufacturing and overseas treatment – by acquiring privately held Amorcyte Inc. (See BioWorld Today, July 18, 2011.)

In May, Fate Therapeutics Inc., of San Diego, attracted a healthy investment from Takeda Ventures Inc., the corporate venture arm of Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. (See BioWorld Today, May 11, 2011.)

And two other regenerative medicine companies, VistaGen Therapeutics Inc., of South San Francisco, and IntelliCell Biosciences Inc., of New York, muscled their way into the public markets earlier this year through reverse mergers. (See BioWorld Today, May 18, 2011.)

Although the early enthusiasm for regenerative medicine focused on theoretical clinical breakthroughs, a growing body of evidence suggests that redelivering a patient's own stem cells to a damaged part of the body does improve the functioning of that tissue, Aras said. The differentiating factor for SironRX is that SDF-1 triggers tissue repair by recruiting a patient's own circulating stem cells to repair damage to the affected tissue and to help prevent stem cells in the area from dying.

"We're delivering a molecule, and that molecule actually brings the body's own stem cells" to the damaged area, creating a more efficient and longer-lasting mechanism to treat the injured tissue, Aras said.

From a commercial perspective, SironRX's approach "significantly reduces the cost and complexity of manufacturing and delivering this product to patients," he added.