BioWorld International Correspondent

MUNICH, Germany - Modex Therapeutics Ltd. successfully completed a Phase I clinical trial of Allox, the company's second product for treating chronic skin wounds. Allox is an off-the-shelf allogeneic cell-based product, aimed at a market of 5 million cases worldwide.

The company's stock was largely unchanged following the news, amid a general downward trend in biotech issues on the Swiss market.

"Allox is very important us, as our second product for treating chronic skin wounds," David Jones, Modex's chief financial officer, told BioWorld International. "Whereas [Modex's] EpiDex is an autologous product, dependent on samples from the individual patient, Allox is completely off the shelf. The much simpler logistics would allow for much lower prices, being closer to the patient and a larger potential market."

The trial was conducted on 12 patients in Switzerland and demonstrated the compound's safety in treating chronic skin wounds. Based on early indications of efficacy, Modex, of Lausanne, Switzerland, will further develop Allox in preparation for a multicenter, randomized Phase II trial the company plans to start in the second half of this year. The immediate next step will be a second Phase I study, beginning at the end of June and using Allox that had been stored in a frozen state. If successful, that test would allow unlimited storage of the compound.

With Allox and EpiDex, Modex intends to offer a complete therapeutic solution for treating chronic skin ulcers. Allox is made of human allogeneic cells suspended in a biopolymer, which is applied on the skin wound as a spray. Competing compounds in this market include growth factor-based products and biological dressings.

Modex was founded in 1996 and develops therapeutic products to treat skin wounds and skin diseases. "We are fortunate to have a fairly strong cash position right now," Jones said. "We have four products in the pipeline and at least three years' funding at current burn rates."

Jones anticipates a wave of consolidation among tissue-engineering companies in both Europe and the United States. He said that Modex intends to be proactive rather than reactive in that trend. Between the state of the market and the company's cash position, he said that Modex likely would not seek additional funding in the near term.

Modex's current product pipeline includes EpiDex and Allox for chronic wounds; Oxyscav for preventing radiation-induced skin damage, such as dermatitis arising from radiation treatment for breast cancer; and stem cell factor (SCF)-derived peptides for treating various skin diseases, such as liver spots. EpiDex will soon enter Phase III testing in the United States. The company is finalizing toxicity tests on Oxyscav, and Jones anticipated that Phase I tests would start soon in Europe. SCF is still in preclinical development. Jones added that Oxyscav and SCF would likely have their markets to themselves.