|Regeneron soars on eye drug study results. Apricus submits SPA for cancer study. OraSure surges on HIV test update|
|By BioMedReports.com Staff|
|Monday, 22 November 2010 19:32|
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 22, 2010.
Apricus Biosciences, Inc., (Nasdaq:APRI) today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco, its proprietary treatment for liver cancer with the FDA. The FDA will review the protocol under its Special Protocol Assessment (SPA) program, under which the FDA would give approval for the trial’s design, clinical endpoints and statistical analysis. The Phase 3 study is expected to take about 12-24 months depending on the recruitment of patients. If the trial shows positive results within the parameters agreed upon in the SPA, the data would then be expected to provide the basis for the filing of a New Drug Application for marketing approval of PrevOnco in the U.S.
Shares of Apricus soared 24% or 65 cents to close the day at $3.35. Earlier in the day the stock hit an intra-day high of $4.12.
Shares of Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) shot up Monday after the company, along with Bayer HealthCare today announced that in two parallel Phase 3 studies in patients with the neovascular form of age-related macular degeneration (wet AMD), all regimens of VEGF Trap-Eye, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month. The primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab, which is marketed by Roche under the trade name Lucentis. The disease usually effects older adults results in vision loss as new blood cells grow beneath the retina, leaking blood and fluid and causing retina damage and distorted vision and can eventually continue to blindness. The block buster drug Lucentis is currently the only FDA approved treatment for Wet AMD.
Shares of Regeneron gained $4.86, nearly 20%, to finish Mondays trading session at $29.53
Receipt of the IDE will allow the Company to proceed with the final phase of clinical testing which consists of a study in which individuals will conduct unsupervised self-testing using the investigational OTC version of the OraQuick HIV test with an oral fluid collection.
Shares jumped 50 cents or 11.14% to $4.99 on volume of more than 1 million.
Heavy volume pushed shares of Advanced Cell Technology, Inc. (OTCBB:ACTC) up more than 42% today. As reported earlier today on BioMedReports, the company announced that the US Food and Drug Administration has cleared the Company’s Investigational New Drug (IND) application to immediately initiate a Phase I/II multicenter clinical trial using retinal cells derived from human embryonic stem cells (hESCs) to treat patients with Stargardt’s Macular Dystrophy (SMD), one of the most common forms of juvenile macular degeneration in the world. The decision removes the clinical hold that the FDA had placed on the trial.
Clinical Data, Inc. (NASDAQ:CLDA), today announced that data from clinical trials of vilazodone the companys novel investigational compound for the treatment of major depressive disorder (MDD) were presented at the annual meeting of the United States Psychiatric & Mental Health Congress. The presentations include results from two placebo-controlled Phase III clinical trials of vilazodone, as well as from a long-term safety study demonstrating vilazodone’s therapeutic profile as a potential treatment for MDD.
"These data demonstrate the clinical profile of vilazodone, including its effects on overall sexual function, which was shown to be similar to placebo when measured by validated scales," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. "Its unique mechanism of action as both a Serotonin 1A receptor Partial Agonist and Reuptake Inhibitor (SPARI), would make vilazodone, if approved, the first compound with a new mechanism to treat depression in well over a decade."
A New Drug Application for vilazodone was accepted for review by the FDA on May 21, 2010 with a January 22, 2011 PDUFA date.
Shares of Regenicin, Inc. (OTC Bulletin Board:RGIN.ob) were up 14% today. The U.S. Department of Defense recently awarded more than $18 million in funding to a unit of Lonza Group, Ltd. for the development and commercialization of the therapeutic candidate, PermaDerm for the treatment of severe burns among U.S. troops and civilians. Regenicin has an agreement with Lonza pursuant to which Regenicin has been charged to obtain FDA approval for the commercial sale of PermaDerm. The funding will assist Regenicin and Lonza in advancing the clinical trials to be conducted in connection with the FDA approval process. PermaDerm an engineered skin substitute grown from a patient's own skin cells, has already been used to treat more than 150 pediatric, catastrophic burn victims through an Investigation Device Exemption issued by U.S. Food and Drug Administration (FDA). This is PermaDerm's first clinical trial to be conducted on adults, a major milestone for achieving pre-market approval by the FDA.
The initial trial will contain 10 patients, both male and female, between the ages of 18 and 40, who suffer third-degree burns. These trials and future trials will take place at the United States Army Institute of Surgical Research at Fort Sam Houston and at a second site to be determined.
After the bell shares of Maxygen, Inc. (Nasdaq:MAXY), were up more than 11% after the biotechnology company focused on the development of improved protein drugs, announced that it will distribute substantially all of the shares of the common stock of Codexis, Inc. (Nasdaq:CDXS) that it owns, as well as approximately $30.0 million in cash, by way of pro rata special distributions to Maxygen’s stockholders. Maxygen stockholders will receive approximately 0.19 of a share of Codexis common stock for each outstanding share of Maxygen common stock they own at the close of business on December 3, 2010.
Assisted Living Concepts, Inc. (NYSE: ALC) stated today that it is disappointed with recent actions taken by the New Jersey Department of Health and Human Services and disputes allegations in an order issued by the Department on Friday, November 19, 2010.