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Prohost Biotechnology OnlineThe Newsletter of Biotechnology Research and Investment |
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THE WEEK OF PSORIASIShugegaypass x nd23 xDate: 12 Dec 2007 Commentshttp://www.hugegaypass.com/main.htm?id=chikenn http://www.hugemoviepass.com/main.htm?id=chikenn http://www.hugetitspass.com/main.htm?id=chikenn http://www.inthevip.com/main.htm?id=chikenn http://www.megacockcravers.com/main.htm?id=chikenn http://www.mikeinbrazil.com/main.htm?id=chikenn http://www.mikesapartment.com/main.htm?id=chikenn http://www.milfhunter.com/?id=chikenn Date: 25 Jun 2001 CommentsPSORIASIS From no hope in treating psoriasis, to a battle about which novel treatment is better for the inflammatory, or autoimmune skin disease. Biogen first released positive news about its new drug Amevive. It did not survive in the minds of the listeners under the heavy weight of doubt. The clouds accumulated when Biogen’s results, as discussed, hesitated to cross the commonsense valve into the observers' brains. In a couple of days, Biogen raised the number of patients whose psoriasis was reduced to the limit of the gold standard from 21% of patients taking Amevive to 33%. According to Biogen, the 21% figure was obtained by measuring patients after 14 weeks, which was the actual clinical goal of the trial. The higher number was obtained by measuring patients at their best point during the 24-week trial, a more relevant way of measuring results, Biogen executives argued. The results were very satisfactory, yet, the problem is that Wall Street turned the psoriasis carnival into a competition in a race between the drug Amevive developed by Biogen and Xanelim developed by Xoma, whose results stated that 39% of the psoriasis patients taking Xanelim were able to reduce their psoriasis symptoms by 75%. The firms involved did not make any wrong statements but the violent waves of Wall Street ocean decided to start by sinking Genentech/Xoma, then Biogen, each in turn on very favorable news. At a time, Biogen looked like the winner of the race, when analysts prematurely decided that its drug, Amevive action outlasts that of the other party, slashing Xanelim co-developer Xoma stock by around 15% of its value. Genentech’s stock was not hurt, because Genentech is Genentech, the king of a kingdom that has more drug citizens than any other biotech. Both parties then looked like winners, when all firms started to explain their results. Then finally, the waves took Biogen’s stock down. THE TRUTH The truth is that both products are effective and induce their effects through different pathways making comparison irrelevant. Like most drugs, some patients will benefit from one of them better than the other. The market for psoriasis can accommodate them and ten more products if available. Xanelim is easier to administer than Amevive, as the patients can administer it themselves subcutaneously like diabetics do insulin. But this advantage is irrelevant to the patients that will not benefit from Xanelim, yet, do with Amevive. The same logic can apply to the contrary situation. . Believing, or not believing the companies’ statement and predicting the drug that will be prescribed more, are both speculations that might not stand reality in the market after approvals and use. Conclusion: Investors in Xoma, Genentech and Biogen will all enjoy an approval of products that could be blockbusters. Xoma needs the approval more than the other two firms, at least to put an end to a series of disappointments and compensate for the excellent scientists and the unique struggling of the firm that is determined to occupy a seat it deserves in the front row, where many successful biotech sit. BIOGEN In the past week, Biogen was the target of critics. The attacks did not only come from psoriasis, but from M.S. helped this time by Serono. Serono declared that patients treated with its drug, Rebif, had greater odds (90%) of remaining relapse free than those taking Biogen's Avonex. Also it said that 32% fewer Rebif patients suffered relapses compared with patients taking Avonex. True or false, Serono’s hurdle resides in the fact that Biogen's Avonex enjoys "orphan drug" status in the U.S., which blocks competition until mid-2003. To circumvent the protection of Biogen’s drug, Serono has to convince the FDA, not the media, or us that its product, Rebif, has a superior effect. That’s why Biogen obtained an injunction in Swiss court, barring Serono from releasing its results calling them misleading and lacking scientific rigor and will not stand up to FDA scrutiny. Burt Adelman, Biogen's vice president of medical research said "We can only hope that neither individuals with MS, nor their physicians, will be misled by these data released to further commercial, rather than scientific, goals”. When science is on the right track, attacked biotech firms have decided to defend themselves against gossip and misleading statements by critics. They get angry and now, they counter attack with an unprecedented ferocity. ISIS For psoriasis also, ISIS has initiated a Phase II clinical trial of topical ISIS 104838. The antisense drug is an inhibitor of TNF-alpha, which has been shown to be an important drug target to treat inflammatory diseases. This is the second drug from Isis' dermatology program to enter the clinic. The first topical antisense drug to enter clinical trials was ISIS 2302, an antisense inhibitor of Intercellular Adhesion Molecule-1 (ICAM-1). Topically inhibiting TNF-alpha is exciting. It seems to have fewer side effects and more convenient dosing than intravenous (IV) systemic treatments. The double-masked, paired-plaque, placebo-controlled Phase II trial of ISIS 104838 will enroll 60 patients with psoriasis in eight U.S. sites. Antisense is on the road to success. MEDIMMUNE AND BIOTRANSPLANT Also presented at the International Psoriasis Symposium and European Congress on Psoriasis, held in San Francisco, some results from clinical trials on MEDI-507 (siplizumab), developed by MedImmune (MEDI) and BioTransplant (BTRN) for the treatment of psoriasis. The results from three clinical trials showed that the drug was generally safe and well tolerated. - Patients experienced improvement in psoriasis, as measured by PASI (Psoriasis Area and Severity Index) score via both intravenous and subcutaneous routes of administration. - Further, preliminary follow-up data indicates that improvement in patients' psoriasis appears to be durable following completion of treatment. A broad Phase II program is underway and expect to provide additional data from Phase I program later this year at the European Society of Dermatological Research Meeting to be held September 20 - 22, 2001 in Stockholm, Sweden." Studies presented Saturday June 23, 2001 at the International Psoriasis Symposium included: - A Phase I, open-label, single-dose intravenous safety study involving 14 moderate-to-severe psoriasis patients who were given 0.0004 mg/kg, 0.0012 mg/kg, 0.004 mg/kg, or 0.012 mg/kg of siplizumab; - A Phase I/II, open-label, dose-escalation study involving 26 `moderate-to-severe psoriasis patients who received up to 8 weekly intravenous infusions of siplizumab at 0.0012 mg/kg, 0.004 mg/kg, 0.012 mg/kg or 0.04 mg/kg; and - A Phase I/II, open-label, dose-escalation study involving 39 moderate-to-severe psoriasis patients who received up to 12 weekly subcutaneous injections of siplizumab at 0.1 mg, 0.3 mg, 1.0 mg, 3.0 mg, 5.0 mg or 7.0 mg. In all three studies, siplizumab was found to be generally safe and well tolerated. Side effects were generally considered mild and most commonly included chills and headache in the intravenous studies, and minimal injection site reaction. - Reductions in targeted lymphocyte populations were dose-dependent and less significant when siplizumab was administered subcutaneously. -Improvement in psoriasis, as measured by PASI score, was observed in all dose groups studied and was most notable among patients at the highest dose levels. Overall, more than 70 percent of all patients treated experienced at least 25-percent improvement in PASI score. At the highest dose groups (0.04 mg/kg in the intravenous studies or 5.0 mg and 7.0 mg in the subcutaneous study) more than 55 percent of patients experienced at least a 50-percent improvement, while more than 33 percent showed at least a 75-percent improvement in their disease. THE PRODUCT Siplizumab is a humanized monoclonal antibody that binds to the CD2 receptor found on the surface of T-cells and natural killer (NK) cells. By binding to CD2, siplizumab selectively suppresses the function of T-cells and NK cells. T-cells are an essential part of the pathophysiology of psoriasis, and it is believed that modulation of T-cell activities may be therapeutically advantageous in the treatment of psoriasis. Psoriasis is a chronic illness affecting as many as 6 million Americans. Annual outpatient costs for psoriasis management have been estimated to be more than $1 billion. MedImmune initiated its Phase II development program with siplizumab earlier this year. Currently, the company has two active Phase II trials underway: a randomized, double-blind, placebo-controlled, intravenously dosed Phase II study being conducted at approximately 25 sites in North America involving 124 moderate-to-severe psoriasis patients; and a randomized, double- blind, subcutaneously dosed Phase II trial being conducted at approximately 20 sites in Europe involving approximately 120 moderate-to-severe psoriasis patients. MedImmune acquired exclusive worldwide rights to siplizumab from BioTransplant in 1995. Siplizumab is the humanized form of BioTransplant's murine monoclonal antibody, BTI-322. BioTransplant has retained the right to use BTI-322 and/or siplizumab in its proprietary ImmunoCognance(TM) systems, which are designed to re-educate the immune system to accept foreign tissue: The AlloMune(TM) System for human-to-human transplantation, and the XenoMune(TM) System for porcine-to-human tansplantation. BTI-322 was initially discovered by Drs. Herve Bazin and Dominique Latinne at the Experimental Immunology Unit of the Catholic University of Louvain in Belgium. PROHOST COMMENTS Biotechnology is improving the treatment of psoriasis and is on its way to cure it. Genentech's/Xoma's product, Xanelim is the star know and Biogen's Amevive is an excellent drug. Both firms will obtain approvals and their products will become best sellers. Amevive and Xanelim will not be alone in the market for long. Many other products will prove efficacy and will be approved and marketed, including MEDI's and ISIS' products. The huge market will accommodate them all..
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