Advaxis Reports Preliminary Data from Phase 2 Trial; Neurocrine Announces Fast Track Designation For VMAT2 Print E-mail
By Staff and Wire Reports   
Wednesday, 25 January 2012 19:24
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 25, 2012.

Advaxis, Inc., (OTCBB: ADXS.OB), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, reported preliminary data on the safety and clinical benefit of ADXS-HPV from an ongoing randomized Phase 2 trial of ADXS-HPV with or without cisplatin in Indian women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. Dr. John Rothman, Advaxis Executive Vice President of Science and Operations, presented the preliminary data at the World Cancer Immunotherapy Conference in San Diego, California on Wednesday, January 25, 2012.

The advanced cervical cancer study is being conducted at 17 sites in India, and as of January 25, 2012, 87 out of a planned 110 patients have been enrolled in the study. To be enrolled in the study, all patients must have been previously treated with radiation, and/or chemotherapy, and the cancer must have resumed growth and in most cases has metastasized, as confirmed by CT or radiologic scan. Because data are available to Advaxis in “real time”, the Company is reporting preliminary data on a periodic basis. The initial safety and objective response data for this ongoing study were presented at the AACR New Horizons in Cancer Research: Biology to Prevention to Therapy conference Gurgaon, Delhi (NCR), India on December 14, 2011.

The objectives of this Phase 2 trial are to assess the safety and efficacy of ADXS-HPV (1x109 cfu) with and without cisplatin (40 mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. As of January 20, 2012, 87 patients have received 195 doses of ADVS-HPV. 34% of patients (a total of 30) have experienced a ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events that were transient, comprised of non-cumulative flu-like symptoms that responded to symptomatic treatment, or resolved on their own; and 1 Grade 3 event.

The primary efficacy endpoint of this Phase 2 trial is overall survival. As of January 25, 2012, the percentage of patients alive at 6 months is 62% (34/55); at 9 months is 41% (15/37) and at 1 year is 40% (6/15). Clinical responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) documented to date, which expands on the preliminary data presented at the AACR meeting in December that reported 1 complete response and 3 partial responses. “These data will change, as the study is ongoing and still enrolling. However, we are encouraged by the preliminary safety, tumor response, and survival data,” commented Dr. Rothman.


Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced its VMAT2 inhibitor product candidate, NBI-98854, has been granted Fast Track designation by the FDA for the treatment of neuroleptic-induced tardive dyskinesia.

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious diseases and address unmet medical needs. The Fast Track designation allows more frequent interactions with the FDA during the drug development process, which assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

"The FDA's Fast Track designation recognizes the significant need for an effective treatment for tardive dyskinesia," said Christopher F. O'Brien, M.D., Chief Medical Officer of Neurocrine Biosciences. "We look forward to continuing to collaborate with the FDA on the development of NBI-98854, and welcome the opportunity for increased interactions with the Agency."

Also Wednesday:

Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, will report financial results for the fourth quarter and full year 2011 on Thursday, February 23, 2012, after the close of the market.

Digirad Corporation (NASDAQ: DRAD) today announced that it has received Conformitee Europeene (CE) Mark approval for its Cardius® X-ACT imaging system, enabling Digirad to market and manufacture its advanced, solid-state camera system in the European Union.

eHealthInsurance (NASDAQ: EHTH), the leading online source of health insurance for individuals, families and small businesses, released an updated list of open enrollment periods for child-only individual health insurance plans in states where information was available.

Healthcare Services Group, Inc.'s (NASDAQ: HCSG) Board of Directors has declared a regular quarterly cash dividend of $.16125 per common share, payable on March 16, 2012 to shareholders of record at the close of business February 24, 2012.

Reed's, Inc. (NASDAQ: REED), maker of the top-selling sodas in natural food stores nationwide, announced today that annual revenues increased 23% to more than $25 million for 2011. The fourth quarter of 2011 marked the 9th consecutive quarter of 20%-plus growth.

Syneron Medical Ltd. (NASDAQ: ELOS)
, the leading global aesthetic device company, announced today that China's State Food and Drug Administration (SFDA) has cleared its eLaser, eLight, eMatrix, eMax and VelaShape systems, significantly expanding the Company's product offering to Chinese aesthetic practitioners and patients.

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