After the market closed on Thursday, Array BioPharma Inc. (Nasdaq: ARRY) announced its preliminary analysis of results from a study examining ARRY-162, a small molecule MEK inhibitor, in a 12-week Phase 2 clinical trial with 201 patients. The patients had active rheumatoid arthritis (RA) that was not completely responsive to methotrexate. This study included a placebo group and three different dose groups of ARRY-162, all on a stable background of methotrexate. None of the treatment groups demonstrated a statistically significant ACR20 response rate compared to the placebo group at 12 weeks (p=0.459), therefore the study did not meet the primary endpoint.

Overall, the placebo response rates in this study were higher than expected for this patient population and showed regional differences, with patients in South America (99 patients) having substantially higher placebo response rates than those in Eastern Europe (101 patients). In Eastern Europe when patients in the three active treatment arms were combined, there was a trend towards efficacy, as measured by DAS28-4(CRP) (p=0.067), “Good” EULAR response (p=0.105) and ACR20 response rate (p=0.115). Array is conducting a full analysis of safety, efficacy and pharmacokinetic data from this study and expects to present complete results at a medical conference in 2010.

“This is the first clinical trial evaluating the modulation of the MEK pathway for the treatment of chronic inflammatory disease,” said Kevin Koch, Ph.D., President and Chief Scientific Officer. “While we are disappointed in the overall efficacy outcome, we were pleased with the confirmation of the favorable safety profile and are continuing to evaluate the regional results. Previously we announced our strategy to rapidly advance ARRY-162 for the treatment of cancer patients. We initiated a Phase 1 oncology trial last month and patient dosing is underway.”

Array will host a conference call on Friday, September 4, 2009, at 9:00 a.m. ET to discuss these results (see conference call details below). Array has also posted additional slides discussing these results on the Investor Relations section of Array’s website at www.arraybiopharma.com.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Array BioPharma Inc. (Nasdaq:ARRY) will report financial results for the first quarter of fiscal 2010 on Monday, November 2, 2009, and will hold a conference call on Tuesday, November 3, 2009 at 9:00 a.m. eastern time to discuss these results.

Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the 20th Annual Healthcare Conference in New York City at 3:55 p.m. ET on Wednesday, November 4, 2009.

Clinical Data, Inc. (NASDAQ:CLDA) announced it has raised gross proceeds of approximately $47.4 million through the public offering of 2,750,000 newly issued shares of its common stock at a price of $17.25 per share.

Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) announced it will release its 2009 third quarter financial results after the market closes on Thursday, November 5, 2009.

SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) announced a corporate restructuring will reduce its U.S.-based workforce by approximately 17%, primarily in research and development.

Safeguard Scientifics, Inc. (NYSE:SFE), a holding company builds value in growth-stage life sciences and technology companies, announced it led a $17.4 million Series B financing round for Quinnova Pharmaceuticals, Inc., with participation from existing investors Thomas, McNerney & Partners and H.I.G. BioVentures.

A.P. Pharma (Nasdaq:APPA), a specialty pharmaceutical company, announced on October 26, 2009, the Company received notice the Nasdaq Listing Qualifications Panel (Panel) has granted the Company’s request to transfer the listing of the Company’s common stock from The Nasdaq Global Market to The Nasdaq Capital Market, which will take effect with the opening of the market on Wednesday, October 28, 2009.

CardioNet, Inc. (NASDAQ:BEAT) announced the U.S. Patent and Trademark office has granted patent number 7,587,237 (“Biological Signal Management”) to CardioNet.

Neoprobe Corporation (OTC:NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced it would report its financial results for the third quarter of 2009 on Monday, November 2, 2009 after the close of the financial markets.

Alcon, Inc. (NYSE:ACL) reported global sales rose 5.9 percent to $1,614 million for the third quarter of 2009, or a 9.0 percent increase excluding the impact of foreign exchange fluctuations.

Antares Pharma, Inc. (NYSE:AIS) announced Dr. Paul K Wotton, Ph.D., President and Chief Executive Officer, will present at the 20th Annual Oppenheimer Healthcare Conference on Tuesday, November 3, 2009 at 4:30 pm ET (Eastern Time).

Nektar Therapeutics (Nasdaq:NKTR) announced it has completed enrollment ahead of schedule in its Phase 2 clinical study of NKTR-102 in platinum-resistant ovarian cancer.NKTR-102 is Nektar's investigational proprietary compound currently being evaluated in Phase 2 clinical development in ovarian, breast and colorectal cancers.

Arrayit Corporation (OTC:ARYC) announced the sale of a system to the Center of Excellence for Nucleic Acid-Based Technologies (CENAT) in Poznan, Poland.

Enzon Pharmaceuticals, Inc. (NASDAQ:ENZN) announced it will report its financial results for the quarter ended September 30, 2009, on Tuesday, November 3, 2009 at approximately 8:00 am Eastern Time (ET).

Advaxis, Inc., (OTC:ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, completed a second Company-run debt financing, as of October 26, 2009.

BioSphere Medical, Inc. (NASDAQ:BSMD) – the pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy –reported financial results for the three and nine months ended September 30, 2009.

Phase Forward Incorporated (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced it will be hosting an analyst session on Wednesday, November 4, 2009, in conjunction with the Phase Forward 8th Annual International Users Conference in Boston, MA.

SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced it will host a live webcast of its fourth quarter and fiscal year 2009 conference call on Wednesday, November 4, at 4:00 p.m. CT.

Genta Incorporated (OTC:GETA) announced the Company will host a conference call and live audio webcast to review top-line results of its Phase 3 trial of Genasense® in patients with advanced melanoma.

UnitedHealth Group (NYSE:UNH) announced the company has appointed both Christopher J. Walsh and Mitchell Zamoff to the position of executive vice president and general counsel, effective immediately.

CNS Response, Inc. (OTC:CNSO) announced that the company will present top-line results from its multi-site clinical trial next week at the U.S. Psychiatric and Mental Health Congress.

Bio Solutions Corp. (OTC:BISU) announced the introduction of their new website:  http://www.bio-solutionscorp.com".

Last week, Array BioPharma (ARRY) announced that its most advanced, wholly-owned MEK inhibitor, ARRY-162, which was being developed to treat rheumatoid arthritis patients, failed to achieve a better response than placebo in a mid-stage trial. The study was designed to assess ARRY-162 in 201 patients with active rheumatoid arthritis who were not completely responsive to the [...]

(ARRY) Setback for Array BioPharma’s Drug

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