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XOMA (XOMA): What would erase investors’ reservations?

Prohost Biotech - Thursday, November 11, 2010

According to data from its IL-1 beta inhibitor drug Xoma 052 in patients with uveitis, all seven patients with Behcet's uveitis enrolled in the XOMA 052 trial experienced rapid reduction of intraocular inflammation and improvement in visual acuity following a single treatment with the drug. A recent data presented at the 2010 American College of Rheumatology Scientific meeting demonstrate that all the five patients re-treated with XOMA 052 due to a recurring uveitis exacerbation have responded all over again to XOMA 052 and maintained their response for several months. Cytokine data showed reduced levels of IL-1 beta, IL-1 alpha and IL-6, as compared to baseline, with an increase in the levels of interferon gamma, which protects against infection.

Xoma results are assuring. They are extremely important because having good news from the drug on Behcet’s uveitis increases the odds of XOMA 052’s success in diabetes. Uveitis, is an inflammation of the middle layer of the eye known as the uvea but the term might be used to refer to any inflammatory in the interior of the eye. The condition is said to be responsible for 10% of  blindness in the United States. It requires urgent treatment. Behcet's disease causes inflammation, including Behcet’s uveitis, which is considered the severest form of uveitis. The major exacerbations of symptoms are common and could lead to retinal detachment, vitreous hemorrhage, glaucoma and eventual blindness. An accumulation of vitreous haze can block eyesight or cause the loss of visual acuity. Patients may go from 20/20 eyesight to loss of vision during the course of an exacerbation. An immediate effective treatment is necessity. The problem is that safe and effective treatments for Behcet's uveitis are currently limited to corticosteroids and off-label use of immunosuppressive drugs, which have serious side effects. They cannot be administered for a long time and have limited benefit on this condition.

Do the announced these good results from XOMA 052 offer a sign of hope after years of disappointments with the firm?

We might say with reservation. The reservation would be abandoned if and when Xoma succeeds in bringing in a serious partner on the drug that is ready to sign a fair agreement. A fair agreement in this case means an agreement with terms that takes in consideration the real value and promises of XOMA 052 as they are estimated based on the drug’s clinical trial results. The best case scenario for Xoma is to make sure that the terms of the agreement would also consider the fact that the drug is expected to improve the prognosis of several devastating diseases, including diabetes, which has a huge market. The fairness should be reflected in the upfront payments, milestone payment and in the revenues that Xoma would generate from the approved drug. Such agreement would be life-changing for Xoma and fair for its shareholders.

Xoma is a genuine biotech firm and has all the scientific and technological fundamentals, but lags behind in financial fundamentals. Years ago, scientists and analysts in the biotech arena expected the firm to become a second Genentech or Amgen. It didn’t. Instead, Xoma became a cash burner with no hope for any rehabilitation. A chain of bad events took place simultaneously, including the failure of a good antisepsis drug, which had saved many children’s lives during clinical trials, shortsighted managerial decisions, including excessive futile spending on the wrong projects and signing unfavorable partnership agreements. Adding fuel to fire was the recall of the psoriasis drug developed with Genentech because of side effects, which contributing to increasing the degree of Xoma’s financial devastation. These events and mistakes were bad enough to bring down the value of the stock from over $30, its all time high, to under $0.40, forcing a 15 to 1 reverse split to avoid delisting from the NASDAQ.

Will XOMA become the penny stock that realizes the dream of its holders?

XOMA 052 is a unique antibody that binds strongly to interleukin-1 beta (IL-1 beta) believed to be involved in Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout, and auto-inflammatory diseases. The drug and its therapeutic targets are validated by the fact that other therapeutic IL-1 inhibitors designed to treat inflammatory conditions have been approved, marketed and used on over 200,000 patients. The drug’s advantage over other approved IL-1 inhibitors are its strong binding capability and its long half-life, which enables administering it only once, a month, or once every two months, instead of several times a week, which is the case with current drugs. A successful emergence of the drug as a diabetes medication would set a historical precedent for Type 2 diabetes, and a historical improvement over the current use of devastating immunosuppressant drugs in juvenile diabetes caused by autoimmune aggression. Past clinical trial results in Type 2 diabetes were promising.

The fact that the recent data on uveitis are from a small number of patients does not downplay the importance of the results, which are outstanding. They should definitely raise our expectations from XOMA 052 and increase its odds of becoming a type 1 and Type 2 diabetes medication.

XOMA 052 is in phase 2 trials in patients for Type 2 diabetes and Type 1 diabetes. Phase 2 trials were initiated based on the successful 98 patient Phase 1 program in Type 2 diabetes. In these trials, XOMA 052 was well-tolerated and demonstrated evidence of biological activity in diabetes measures and on cardiovascular biomarkers. The company has also demonstrated a potential of XOMA 052 in in vivo models of atherosclerosis and cardiac remodeling and in an in vitro model using human myeloma, or plasma cell cancer, cells.

XOMA develops products with Novartis AG, Schering Corporation, a subsidiary of Merck & Co., Inc. and Takeda Pharmaceutical Company Limited. The firm’s technologies have contributed to the successful development of Lucentis® (ranibizumab injection) for wet age-related macular degeneration and of Cimzia® (certolizumab pegol) for rheumatoid arthritis and Crohn's disease. Xoma’s technology is being licensed to numerous firms who used them to develop products; many of them are in clinical trials.

All we can say at this time is GOOD LUCK.

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