Amylin Pharmaceuticals Inc., of San Diego, announced positive results from a 28-week dose-ranging study of pramlintide/metreleptin in overweight and obese patients. The Phase II study successfully characterized patients who responded best to treatment and provided important information to inform dose selection. Evaluable patients with a starting body mass index (BMI) less than 35 kg/m2 (n= 149), and treated with the highest pramlintide/metreleptin doses, experienced significantly more weight loss on average (11 percent; 22 pounds, p < 0.01) than those receiving placebo (1.8 percent; 4 pounds) or either agent alone (approximately 5 percent; 10 pounds). The weight loss was predominantly due to a reduction in fat mass (approximately 18 of the 22 pounds lost). The combination therapy was well tolerated, and no cardiovascular or neuropsychiatric safety signals were observed. As part of an ongoing extension protocol, study participants may continue on therapy for a total of 52 weeks. Data from the study will be submitted for presentation at a future medical meeting and for publication in a peer-reviewed journal. Shares of Amylin (NASDAQ:AMLN) rose 11 cents to close at $12.40.

• Array BioPharma Inc., of Boulder, Colo., said preliminary results from two trials indicate that ARRY-797, being developed in rheumatoid arthritis, was well tolerated with a pharmacokinetic profile consistent with earlier studies. In the 28-day, three-arm RA study with a total of 28 patients, ARRY-797 showed inhibition of CRP levels (marker of inflammation) only during the first three weeks of dosing and a beneficial reduction in NTx levels (marker of bone remodeling) throughout the study. In addition, ARRY-797 showed a trend to improve the patients' assessment of pain (VAS score) over the course of the study. It also was tested in a Phase I seven-day dose escalation trial up to 1,200 mg daily of p38 inhibitor in healthy volunteers.Since the results are similar to other p38 inhibitors evaluated in rheumatoid arthritis, the company has decided to discontinue testing ARRY-797 in chronic inflammatory diseases but said it believes that a p38 inhibitor holds promise in treating patients with cancer and sub-chronic pain.

• Harvest Technologies Corp., of Plymouth, Mass., said its 60-patient trial in Chennai, India using the company's BMAC System to treat patients with non-reconstructable critical limb ischemia has completed enrollment. interim results on the first 30 patients treated with at least 12 weeks follow up showed a limb salvage rate of 87.5 percent and significant improvement in reduction of pain, improvement in perfusion measures and in quality of life. Results on the total study population will be presented in October at the Indian Society of Vascular Surgery meeting.

• Revance Therapeutics Inc., of Newark, Calif., said that RT001, a topical botulinum toxin type A under investigation for the treatment of crow's feet wrinkles, demonstrated efficacy and safety in a Phase IIb study. The randomized, double-blind, parallel-group, dose-finding study showed efficacy vs. placebo at primary and multiple secondary endpoints. The results are consistent with earlier Phase II studies.

• Rigel Pharmaceuticals Inc., of South San Francisco, said that R788 (fostamatinib disodium) produced significant clinical improvement in rheumatoid arthritis (RA) patients in THE TASKi2 Phase IIb trial of 457 patients treated for up to six months. The groups treated with 100 mg of R788 bid (twice a day) and 150 mg qd (once a day) reported higher ACR 20, ACR 50, ACR 70 and DAS28 response rates than the placebo group. The efficacy results for the two dosing groups were comparable, although the response rates for the 100 - mg bid group was uniformly greater. Consistent with the previous Phase IIa trial (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were expected and appear to be manageable, the company said. Rigel added that the significant, early sustained efficacy, combined with a good safety profile, supported its plans to conduct partnership discussions for R788 and initiate a Phase III program in RA in the first half of 2010 with a corporate partner. Shares of Rigel (NASDAQ:RIGL) rose $1.92 cents, or 17 percent, to close at $13.16.