BioWorld International Correspondent

PARIS - TxCell raised €10.5 million in a Series A financing from five Paris-based venture capital firms.

The investors were Auriga Partners, AXA Private Equity, SPEF Venture, BioAm (a fund managed by Biogestion SA) and CDC Entreprises Innovation (the venture capital arm of the Caisse des Dép ts et Consignations). TxCell President Philippe Ballero said there was no lead investor.

"They each put in a similar amount," he told BioWorld International.

TxCell, which is headquartered in Nice, France, was created in 2001 and obtained initial funding of €100,000 from Inserm-Transfert (the private equity arm of France's National Institute for Health and Medical Research) in 2003. The latest funding will be sufficient to keep the company going for a further three years, Ballero said.

TxCell was founded by Hervé Groux and Françoise Cottrez to exploit the role of Trl (T-regulatory) cells in maintaining the balance of the immune system, which first was demonstrated by Roux in a paper published in October 1997. He found that chronic inflammation of the immune system is caused by an imbalance between effector cells and regulatory cells, due to the latter failing to play their role of re-establishing immune system balance by arresting inflammatory reaction through the local secretion of anti-inflammatory cytokines.

The clinical application of the discovery entails removing, isolating and characterizing the patient's Trl cells and then increasing them in number before re-injection. That technique has generated a 100 percent response rate in animal studies, Ballero said, not only restoring the effectiveness of Trl cells, but also showing a "total absence of relapse, whatever the model used."

TxCell is using the technology to develop therapies for a number of diseases characterized by chronic inflammation, such as Crohn's disease, multiple sclerosis, psoriasis, asthma and rheumatoid polyarthritis. Ballero stressed that the approach "cures the disease," rather than simply providing a palliative or symptomatic solution as existing therapies do. Not only is the treatment applicable to a number of different pathologies, but it also is tailor-made for the individual patient.

TxCell's next move will be to start a Phase I/IIa trial in Crohn's disease, which Ballero said should be initiated toward the end of 2005 and completed in late 2006 or early 2007. After that, the company plans to go directly to a Phase IIb/III trial in Crohn's and a second indication, which should be completed in 2009.

If the results confirm the validity of the technology, Ballero anticipates that the product could receive regulatory approval in 2010, with the possibility of "compassionate sales" being allowed as early as 2009.

He added that, on the strength of the results of the initial clinical trial, the company intended to launch a second funding round in 2007 and to look for a partner to complete the development of the product and handle its commercialization. Beyond that, Ballero said, TxCell could license its technology out to other companies.

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