@DLesh tweets, "AVII raised to Buy at Think and a $3.50 target. giddy up." He's referring to AVI Biopharma ( AVII). On Thursday, ThinkEquity initiated research coverage with a buy rating and a price target of $3.50 a share. I've already written favorably about AVI and its early-stage drug for Duchenne muscular dystrophy (DMD) after seeing the company present at a September health care investment conference. The company's DMD drug, AVI-4658, is designed to "skip over" the section of damaged gene in DMD patients and therefore restore the gene's ability to produce partially functioning dystrophin, a protein that plays a key role in muscle function and repair. The genetic inability to make dystrophin is what causes muscular dystrophy. Last week, researchers presented updated and promising results from a small phase I study of AVI-4658. The study enrolled just 19 boys with DMD and used relatively low doses of the drug. Despite these limitations, three patients had substantial increases in dystrophin-functional muscle fibers after 12 weeks of treatment with AVI-4658 and 14 weeks of follow up. The study also picked up decreases in the level of inflammatory markers in the muscle cells, which suggests the drug is having a positive effect on the underlying muscle-wasting course of DMD. Functional tests like the six-minute walk were inconclusive but that's not surprising given the small doses used and the short duration of the study. All these data are promising but very early. The next, important step for AVI will be to begin a larger, randomized, controlled phase II study using higher doses of AVI-4658. AVI hopes to get this study started before the end of the year.
Jerry M. asks, "I wonder if you will comment on MELA Sciences' (MELA) announcement of the online publication of its research findings on MelaFind in the Archives of Dermatology? At first blush, it looks like some new information in response to your past critiques of their device. It seems to be only the publication of data that was done in 2009 and accepted for publication in August 2010 and referencing nowhere the FDA's letter to them of non-approvable status earlier this year. Is this an honest effort by the company to clear up any doubts about their research? I enjoy your reporting." If you believe the MelaFind device is an important advance in the early detection of melanoma, or skin cancer, then the publication this week of the phase III study supports your view. MELA previously disclosed the results from this study demonstrating MelaFind's 98% sensitivity and 9.5% specificity, which the company claims meets all of the FDA's pre-specified requirements for the device's approval. These results were essentially repeated in the Archives of Dermatology paper. The paper doesn't shed any new light on why, if the MELAFind results are so robust, the FDA issued a non-approvable letter after completing its device review in March. MELA responded to the FDA's rejection and asked for an advisory panel to be convened, which will take place on Nov. 18. You know I'm a MELAFind skeptic, so for me, the new paper raises more questions than provides answers to any of my past critiques. The MELAFind statistics issue raised recently by the analyst at Biologic Equity Research remains unresolved. The new paper confirms that the mid-p exact method was used to analyze the MELAFind data but doesn't say one way or the other if mid-p was the prospectively defined statistical test called for in the study agreement reached between MELA and FDA.
Bruce W. asks, "What do you think of Oppenheimer's $12 price target for Somaxon Pharmaceuticals (SOMX)?" Dumb. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: firstname.lastname@example.org.