Assistant

A year after bringing in its first major financing, privately held Circassia Ltd. closed an oversubscribed second round, adding £11 million (US$21.8 million) for expanding its portfolio of technologies aimed at regulating immune response and to accelerate ongoing clinical development programs in allergy.

To date, the Oxford, UK-based firm has raised about £17.5 million, including a £6 million funding round in January 2007 to support an upcoming Phase II study of its lead program in patients allergic to cat dander. The recent financing, which brings Circassia's cash balance to about £15 million, will "help us expand our portfolio and allow us to do more trials," said CEO Steve Harris, adding that it should "take us beyond the end of 2009."

The financing came "in a tough funding market," he said, crediting an investment syndicate that included new investors Goldman Sachs and Invesco Perpetual, along with existing investors Imperial Innovations and Lansdowne Partners.

Spun out of the Imperial College of London, Circassia was created to develop drugs for allergic rhinitis based on a technology that uses T-cell epitopes to desensitize the immune system.

Unlike more traditional immunotherapies, which are designed to dose patients with the whole antigen to build up tolerance - an approach that can produce serious side effects - Circassia's approach is to "take the T-cell epitopes from an antigen," isolated using the company's technology, and create a drug that "gives the therapeutic benefit without some of the side effects," Harris told BioWorld Today.

The technologies identify short peptide sequences, usually 10 to 20 amino acids long, and those peptides then are selected for their ability to bind to multiple major histocompatibility Class II molecules on the surface of antigen-presenting cells.

Administration of the T-cell epitopes is designed to down-regulate the allergic response to the allergens from which the peptide originally was derived.

Importantly, because the peptides are kept short, they do not contain the B-cell epitopes, which are known to cross-link to IgE on the surface of mast cells. It's that cross-linking that causes anaphylactic reactions, Harris said.

Circassia's lead program is in cat dander allergy and "we've got everything ready to move into a Phase II" trial with that program this year, Harris said. Additional programs are expected to follow in grass, ragweed and house dust mite allergies.

In July, the firm gained rights to a second platform technology, known as ToleroTrans, from the University of Birmingham in the UK. Similar to Circassia's allergen technology, the ToleroTrans platform also requires the use of T-cell epitopes to down-regulate unwanted immune responses in organ transplant patients.

"We're again trying to tolerize the body" to accept the new organs, Harris said. But the down-regulation will be selective, an advantage over the immune-suppressant therapies that can leave patients at risk for infections.

Circassia reported in September that it started a blood sample testing program for use of ToleroTrans in kidney transplantation. Scientists will use those samples to assess the T-cell mediated interferon gamma response to the T-cell epitopes, and the company will evaluate those results in preparation for further clinical studies.

Most of Circassia's work is done on a contract basis. The firm has five employees, though Harris said that number likely will increase by a couple in the near term. But the company has long-term plans to recreate itself as a specialty pharmaceutical business, hoping to handle its own marketing and commercialization activities.

"We want to keep all our development rights," Harris said.

In other financings news:

• Access Pharmaceuticals Inc., of Dallas, is adding $2.7 million in a private placement, coming on the heels of its November financing of $9.5 million. The additional money is expected to support the firm's trial program for ProLindac, a DACH platinum prodrug for solid tumors that is in Phase II development. Under the terms, the company agreed to issue to investors Series A convertible preferred stock initially convertible up to 908,000 shares of common stock. Investors also will receive warrants to purchase an additional 454,000 shares at an exercise price of $3.50 apiece. Shares of Access (OTCBB:ACCP) closed at $3 Tuesday, up 10 cents.

• Kamada Ltd., of Weizmann Science Park, Israel, signed a $20 million financing agreement with U.S.-based Hercules Technology Growth Capital Inc. under venture lending terms. Kamada said the deal is aimed at diversifying the company's financing sources and to further finance its strategic plans over the forthcoming years. Kamada, which develops products based on its chromatographic purification technologies, recently concluded Phase I studies of Alpha-1 Antitrypsin, using the eFlow Electronic Nebulizer from PARI Pharma GmbH, in various lung diseases.

• Pro-Pharmaceuticals Inc., of Newton, Mass., filed a shelf registration statement that would allow it to sell up to an aggregate of $10 million of its common stock. Terms, including the number of shares and share price, would be determined at the time of any offering, and proceeds would be used for general corporate purposes, such as clinical development and discovery programs. Pro-Pharmaceuticals, which develops drugs for cancer, liver, microbial and inflammatory diseases, is focusing initially on cancer treatments that use its carbohydrate polymers for targeted delivery of chemotherapeutics.

• Theratechnologies Inc., of Montreal, filed a preliminary shelf registration to raise up to $35 million through the sale of common shares. The number of shares to be offered and share price will be determined at the time of any offering. Theratechnologies filed the shelf to possibly finance continued development of tesamorelin, which is in a Phase III study in HIV-associated lipodystrophy, and to ensure that it has flexibility to review potential strategic alternatives. The company's board initiated a process to explore options for enhancing shareholder value, including strategic partnership transactions, licensings, the acquisitions of complementary products or business or the sale or merger of the company. Shares of Theratechnologies (TSX:TH) closed at C$9.53 (US$9.54) Tuesday, down C12 cents.