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Biotech / Medical : Genta, Inc. (GNTA) -- Ignore unavailable to you. Want to Upgrade?

To: AJAG who wrote (1732)	9/15/2003 1:26:22 PM
From: Jim Oravetz	Read Replies (1) \| Respond to of 1870

Mixed Result for Cancer Treatment There's no successful treatment for malignant melanoma, the terrible skin cancer. Study results announced Wednesday from a widely-watched new therapy did little to change the tragic outlook for melanoma victims. The biotech firm Genta, with its partner Aventis, reported that melanoma patients who got the experimental drug Genasense along with chemotherapy survived 9.1 months, on average, compared to 7.9 months for those who got just chemo. Unfortunately, that difference of 1.2 months may represent a statistical accident of the study group, rather than a survival difference attributable to the drug. That's because the difference in median survival between the two groups fell well short of the level considered statistically persuasive. Genta's product has been one of the last hopes for a technology called "antisense" -- in which researchers hoped to halt disease processes inside cells, by jamming the harmful instructions that cells encode using the nucleic acid molecules known as DNA and RNA. Hopes ran high in the 1990s that tiny strands of antisense DNA could target and destroy the specific RNA messengers involved in a disease. But apart from a rare eye infection -- now treatable with an antisense product from Isis Pharmaceuticals -- antisense has disappointed early hopes. Instead, the attention of researchers has moved to a more powerful nucleic-acid technology called RNA Interference. In the laboratory, RNA Interference has revolutionized the researcher's task of silencing a particular gene to identify the body function that the gene controls. Last week, Merck announced a multi-year program to look for disease treatments with a privately-held firm that's got key patents on RNA Interference -- the Cambridge, Mass.-based Alnylam Pharmaceuticals. Genta and Aventis insist that their Genasense antisense drug worked against melanoma, and they plan to apply for Food and Drug Administration approval by year end. Though Genta Chief Executive Raymond Warrell acknowledges the survival difference from the drug didn't reach statistical significance, he says the FDA could grant approval nonetheless. Warrell says that a subset of the 771 patients showed a statistically-meaningful survival benefit, namely those 480 who'd been followed for 12 months. Warrell predicts that the overall difference in survival will reach statistical significance when all 771 cases reach the 12-month point. If the FDA entertains Genta's subgroup argument -- and the agency has rejected such special pleading with other firms' cancer studies -- Genta's post-study evidence would only impact the study's statistical significance. The one month difference wouldn't change. That outcome disappointed at least one of the researchers in the Genasense trial. "It's not clinically meaningful for me," said Axel Hauschild, a cancer researcher in Kiel, Germany, who spoke on a conference call with investors last week. "We had expected at least a doubling of the remission rate. It's not a very encouraging result." Dr. Hauschild said that he was not persuaded by Genta's claims of significance within subgroups of the melanoma study. He said: "The interpretation of the data may differ between the company and [medical] opinion leaders." After the long-awaited announcement, Genta shares tumbled from their 52-week high of 17.65 on Wednesday morning to close Friday at 14.25. Meanwhile, RNA Interference stands ready to supplant antisense in the hearts of biologists and investors. "RNA Interference ranks up there as one of the four or five game-changing events of the last 20 years," said Alnylam Pharmaceuticals chief executive John Maraganore, after last week's deal with Merck. Maraganore says that Alnylam is considering an IPO. online.wsj.com