The regenerative medicine firm Gamida Cell Ltd. raised $16 million, its fourth round of private financing, to fund various therapeutic programs beyond its lead efforts.

"The money will be used primarily to expand our pipeline," President and CEO Yael Margolin said, "and advance our products toward the market."

The Jerusalem-based company has raised about $36 million in total private equity funding since its 1998 inception, and Gamida Cell plans to use a portion of its new funds to broaden beyond hematological diseases its clinical research of the allogeneic stem cell product StemEx. Those new areas include solid tumors, autoimmune diseases and storage disorders, all of which can be treated with bone marrow transplants to induce remission.

Margolin said that a study in one of those three areas should begin next year, most likely in a disease with higher mortality and morbidity rates.

"We're not really inventing the indications" for StemEx, she said, "but we want to offer [it] as an alternative to bone marrow transplantation in these patients."

But blood cancers represent the product's lead indication and reflect the focus of a joint venture with Teva Pharmaceuticals Industries Ltd., which paid $25 million to work alongside Gamida Cell. In that arrangement, Gamida Cell granted the joint venture an exclusive license to develop and market StemEx specifically for hematological diseases, and both parties would equally split revenues.

StemEx is expected to move into a pivotal study "in the very near future" as a treatment for leukemia and lymphoma, Margolin said, probably at the end of this year or early next year. It has orphan drug status from the FDA for use as hematopoietic support in relapsed or refractory blood cancer patients who are receiving high-dose therapy.

StemEx - made of cord blood highly enriched with stem cells - could be on the market in 2009, Margolin said, adding that "preparations for the marketing effort are already under way." Shown to extend patient survival longer than traditional bone marrow transplants in an earlier clinical study in leukemia and lymphoma, its use also did not cause graft-vs.-host disease or graft failure, two common complications traditional bone marrow transplants.

The product is based on discoveries and innovations made at the Hadassah University Hospital in Jerusalem.

The funds also will be used to expand Gamida Cell's tissue regeneration pipeline, including a cardiac regeneration product that's in advanced preclinical development. For years the company has planned to move that program into the clinic, and now plans are scheduled for the middle of next year. The envisioned Phase I/II study would test ex vivo-expanded, bone marrow-derived stem cells in patients with chronic refractory angina and/or after acute myocardial infarction.

"The field has been very busy in the last three or four years," Margolin said, noting that researchers have been testing bone marrow transplants without any further manipulation to the cells. But based on preclinical studies of Gamida Cell's cardiac product, "we have very good reason to think that we will be able to demonstrate a relative advantage" with the expanded cells.

Lastly, the company plans to apply its new money to develop products for conditions such as neurological disorders and peripheral vascular disease that have been created through other technologies for expanding stem cells. All remain at various stages of preclinical development.

Margolin said the fresh funding would last for "at least two or three years," and coupled with existing cash, allow Gamida Cell to run several clinical trials in that time frame.

The financing round was led by Israel Healthcare Ventures (IHCV), with additional participation from several current shareholders that also are based in Israel: Elscint Biomedical Investment, Denali Ventures, Biomedical Investments and Teva Pharmaceutical Industries Ltd. Gamida Cell reorganized its board in the process, with Biomedical Investments' Ruben Krupik its new chairman. Other board members include Elscint's Mordechai Zisser, IHCV's Hadar Ron, Denali's Noam Karstaedt and Margolin, who previously was at Denali and Teva.