Hoping to begin pivotal testing next year of its cell therapy candidate in acute renal failure, RenaMed Biologics Inc. raised $40 million in private funding to support drug development and manufacturing capabilities.

To date, the company has brought in about $100 million, and this mezzanine round, along with "some other events, should take us into '08," said Greg Phelps, chairman and CEO, while positioning RenaMed to seek a potential public listing.

"That's our hope and our intention," Phelps said.

In the meantime, he added, "we were quite happy with the market reception to our product and the progress that the company has made."

Funds from the latest round will go toward clinical work on RenaMed's lead product, Renal Bio-Replacement Therapy in acute renal failure. That product is described as a hollow fiber dialysis cartridge containing human renal cells for the extracorporeal treatment of ICU patients on dialysis after suffering acute renal failure. It's in a second Phase II study, with top-line results expected during the first quarter of 2007.

Unlike patients with chronic kidney disease or end-stage renal failure, acute renal failure patients have no pre-existing kidney condition, and are suffering kidney failure due to "a variety of precipitating events, such as surgery or trauma or infection," Phelps told BioWorld Today. "These are people with otherwise normally functioning kidneys," whose kidneys shut down, causing a "cascade of severe inflammatory diseases and other organ failure."

The acute renal failure patient population has a mortality rate of 50 percent to 70 percent, he added.

Renal Bio-Replacement Therapy is designed as a short-term, single treatment, and "our intention is to bridge these patients through the crisis to the point where their own kidneys can support them," Phelps said.

Results from the first Phase II trial completed last year showed a 67 percent survival rate at 28 days in patients who received Renal Bio-Replacement Therapy, vs. 39 percent in the control group on conventional dialysis. A 28-day survival rate also is the primary endpoint in the ongoing Phase II study.

Pending positive results, "our aim would be to start Phase III in mid-2007," Phelps said.

RenaMed is partnered with Cambridge, Mass.-based Genzyme Corp. for the joint development and commercialization of Renal Bio-Replacement Therapy in acute renal failure. The companies signed an agreement in September 2005 valued at up to $43 million for RenaMed. (See BioWorld Today, Sept. 29, 2005.)

Funds from the financing also will be used to expand RenaMed's development portfolio, which includes some "product-line extensions" that build on the Renal Bio-Replacement Therapy product, Phelps said, moving into other acute indications such as cardio-renal syndrome and septic shock, both of which also affect ICU patients and have high mortality rates.

Earlier this year, the company said it would be moving its headquarters from Lincoln, R.I., to Westborough, Mass., where it leased space for manufacturing Renal Bio-Replacement Therapy. Phelps said he anticipates that facility "ultimately being used for commercial purposes."

Boston-based TVM Capital and Chicago-based Lurie Investments co-led the financing, and were joined by new investors Toronto-based MDS Capital, New York-based Merlin BioMed Group, Dow Employees' Pension Plan and TSC BioVenture Capital Corp. Existing investors included Apjohn Ventures Fund, of Kalamazoo, Mich.; BD Ventures, of Franklin Lakes, N.J.; Bio One Capital, of Singapore; and North Coast Technology Investors, of Ann Arbor, Mich.

Gert Caspritz, of TVM, and Gerry Brunk, of MDS, joined RenaMed's board.

Metastatix's Series A Raises $3.6M

Atlanta-based firm Metastatix Inc. also brought in private funding, raising $3.6 million in its Series A financing round to support ongoing drug development.

Metastatix intends to use proceeds to identify initial clinical candidates and to advance its first product, a compound aimed at targeting the CXCR4 receptor to inhibit tumor growth and prevent metastasis, to an investigational new drug application.

The company's second program also focuses on CXCR4 and its implication as an entry point in T-tropic HIV infection.

H.I.G. Ventures led the financing round and was joined by new investors The Aurora Funds, CM Capital, SR One and MedImmune Ventures Inc. Existing investors Georgia Venture Partners and Centrosome Ventures also participated, along with the state of Georgia.

As a result of the financing, Bruce Robertson, of H.I.G., was named chairman, and Doug Gooding, of Aurora, along with Ad Rawcliffe, of SR One, and Wayne Hockmeyer, of MedImmune Ventures, received seats on Metastatix's board.

Len Post, former senior vice president of research and development for Emeryville, Calif.-based Onyx Pharmaceuticals Inc., was appointed chairman of the company's scientific advisory board.