A new angle and approach

La Jolla Pharmaceutical acquires RILs from GliaMed, sets sights on regenerative medicine

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SAN DIEGO—Setting a course toward the emerging field of regenerative medicine, with a focus on healing scars, the La Jolla Pharmaceutical Co. has acquired the rights to a novel class of compounds known as Regenerative Immunophilin Ligands (RILs), from privately held GliaMed Inc.

Based in Framingham, Mass., GliaMed is a development-stage biopharmaceutical firm that has developed a small-molecule approach to stem cell therapy. The company states that its drug candidates have the potential to enhance the regeneration of skin and other tissues through the activation of reprogramming genes present in cells at the site of an acute trauma or injury, thus creating autologous stem cells.

RILs are small-molecule compounds that may have the potential to promote the regeneration of a wide range of tissues, including complex skin tissue, lung tissue, cardiac muscle, cartilage and bone, following acute injury, according to GliaMed.

La Jolla plans to rapidly advance the development of lead RIL compound LJP1485 by focusing on scar remodeling. Preclinical animal models have suggested that LJP1485 has the ability to accelerate healing with functionally normal tissue following a surgical wound, reduce pulmonary fibrosis following lung injury and promote the regeneration of cardiac tissue following induced myocardial infarction. A confirmatory preclinical study is being undertaken and is expected to complete by the end of the second quarter.
"We are excited to be advancing the development of this novel class of compounds in the field of regenerative medicine," says Dr. Deirdre Y. Gillespie, La Jolla's president and CEO. "Our initial focus on scar remodeling is based not only on LJP1485's significant therapeutic potential, but also on our belief that it will be relatively quick and straightforward to evaluate clinical proof-of-concept, here."

La Jolla sees the practical and commercial value of these RIL compounds.

"These are small molecules with animal data suggesting that they could regenerate tissue and accelerate healing in a number of conditions following insult," Gillespie adds. "If confirmed clinically, this would be a unique finding, and these compounds would have multiple applications. In addition, we believe that this activity could be investigated in clinical trials in a reasonable timeframe and at a reasonable cost. Other tissues in which animal models have suggested the ability of RILs to regenerate tissues are lung, cartilage and heart muscle which, if confirmed clinically, offer multiple large commercial opportunities."

The next step "is to confirm (replicate) that LJP1485 has the ability to accelerate healing with functionally normal tissue," Gillespie says. "This animal study is ongoing now at a contract research organization (CRO), and the results will be available by the end of June."

To date, GliaMed has shown compelling evidence in animal models that administration of GM1485—a different molecular compound—promotes healing. This includes: Rapid regeneration of all components of skin following surgical wounding, resulting in complete wound healing with minimal scarring; regeneration of cardiac tissue following induced myocardial infarction; and regeneration of central nervous system tissue after occlusive stroke with reperfusion injury.

GliaMed has also shown that RILs induce the de-differentiation of adult human fibroblasts in vitro, and when these cells are placed under appropriate culture conditions, they can be induced to differentiate into cells that express muscle-specific, neuron-specific or glial-specific markers.

Under the terms of the agreement, GliaMed is eligible to receive up to 8,205 shares of newly designated Series E Preferred Stock, which would be convertible into approximately 20 percent of the company's fully diluted outstanding common stock on an as-converted basis. The issuance of the shares will be tied to the achievement of certain development and regulatory milestones.

GliaMed will also be eligible for a potential cash payment if the U.S. Food and Drug Administration or European Medicines Agency approves an RIL compound covered by the agreement in a second clinical indication.

If La Jolla's preclinical animal study of LJP1485 is completed by the end of the second quarter, the company will receive approximately $7.4 million upon the portion of its outstanding preferred stock purchase warrants held by existing investors, followed by forfeiting its right to demand redemption of approximately $5.6 million of Series C Preferred Stock acquired in May 2010.

The proceeds from this warrant, combined with existing cash resources, are then expected to fund La Jolla's operations through the completion of a Phase IIa proof-of-concept clinical study of LJP1485, according to the agreement.

If the Phase IIa study is successful, the balance of the preferred stock purchase warrants will be required to be exercised at that time, raising an additional $3.2 million.

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