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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Webhead who wrote (21695)	6/3/1998 6:43:00 AM
From: Henry Niman	Respond to of 32384

Here's a later version of the Reuter's coverage: Tuesday June 2, 1:57 pm Eastern Time FDA panel backs Seragen cancer drug GAITHERSBURG, Md.,, June 2 (Reuters) - A Food and Drug Administration advisory panel recommended approval of Seragen Inc.'s (SRGN - news) new drug, Ontak, to treat a rare cancer called cutaneous T-cell lymphoma. The panel did not vote on U.S. Food and Drug Administration (FDA) approval, but said that the drug was safe and effective. Ontak was developed by Seragen and Eli Lilly and Co. (LLY - news) . Ligand Pharmaceuticals (LGND - news) will assume the rights to Ontak if a merger with Seragen is approved by the Securities and Exchange Commission. If the FDA follows the panel's advice, which it usually does, Ontak could be approved in six months. Because Ontak has so much toxicity, panelists suggested limiting its use to patients with advanced disease, and to those who had failed previous therapies. Ontak is a genetically-engineered fusion protein aimed at blocking interleukin-2 from binding to tumor cells, eventually causing cell death. CTCL affects only 800 people a year in the United States but is disfiguring, causes chronic immune suppression, and eventually spreads to lymph nodes and organs, causing death. It starts as black skin plaques and mushrooms into external tumors that scale, itch, and promote infections. ''It is not uncommon to find these patients in psychiatric wards, or know when they've arrived at the clinic because of the odor,'' said Seragen consultant Paul Bunn of the University of Colorado. Topical treatments such as phototherapy, interferon and chemotherapy can cause short-lived remissions, but do not cure the disease. The 71 patients studied by Seragen had been treated an average of five times previously and two-thirds had advanced disease. Thirty percent, or 20 patients, had at least a 50 percent or greater reduction in tumors. Patients also said they had less itching and felt better about their appearance. Side effects limited patients' tolerance. Thirty-seven percent dropped out of the study due to toxicity. Ninety percent had flu-like symptoms of fever and chills, and 83 percent had nausea, vomiting and diarrhea. Almost half had infections, and a majority had allergic reactions when the drug was infused. Seragen said the effects lessened with succeeding doses, and could be managed with anti-nausea drugs or steroids, which were not allowed in the study. More Quotes and News: Eli Lilly and Co (NYSE:LLY - news) Ligand Pharmaceuticals Inc (Nasdaq:LGND - news) Seragen Inc (OTC BB:SRGN - news)

To: Webhead who wrote (21695)	6/3/1998 6:51:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Here's what AP had to say after the close: FDA Panel OKs Cancer Immunotoxin Tuesday, June 2, 1998; 6:04 p.m. EDT WASHINGTON (AP) -- A bioengineered toxin should be approved to treat a certain type of advanced lymphoma, government advisers unanimously recommended to the Food and Drug Administration Tuesday. If the FDA ultimately agrees, Seragen Inc.'s Ontak could become the nation's first immunotoxin, a unique type of cancer fighter. At issue is cutaneous T-cell lymphoma, a rare lymph cancer that attacks the skin, starting with severely itchy lesions. Ontak consists of an immune system protein called interleukin-2 and a noninfectious portion of diphtheria toxin. The IL-2 binds to receptors on lymphoma cells, allowing the toxin to slip inside and kill the cells, explained Dr. Patricia Keegan of the FDA's Center for Biologics. Seragen's major study infused Ontak into 71 advanced patients who had failed standard treatments, Keegan said. Thirty percent of tumors significantly shrank; seven disappeared. The study couldn't tell how the tumor shrinkage affected patients' overall symptoms, or how long the effect lasted, Keegan said. Seragen has begun a larger trial to get those answers. But the FDA's advisors said the early study was enough for Ontak to be approved under a special program that allows promising cancer drugs to be sold before final research is done. The FDA is not bound by its advisers' recommendations, but typically follows them. Ontak caused numerous side effects, including fever and flulike symptoms in 90 percent of patients, Keegan cautioned. Most of the side effects responded to brief treatment. But the panel decided the side effects mean Ontak should be offered just to advanced patients who have failed other options, she said.