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Antigenics' Oncophage fails to meet endpoints in clinical trial for treatment of kidney cancer Antigenics Inc.'s Oncophage (vitespen), an investigational kidney cancer treatment, did not meet the primary endpoint of a Phase III study.

The open-label trial, known as C-100-12, included 728 patients who had a high risk of renal cell carcinoma recurrence after surgical removal of a diseased kidney (nephrectomy). Patients were randomized to one of two study arms: nephrectomy plus Oncophase vaccination or nephrectomy alone. The primary endpoint was recurrence-free survival. A secondary endpoint was overall survival.

Results of an independent review by the trial's Clinical Events Committee (CEC) suggested a trend favoring Oncophage plus nephrectomy for recurrence-free survival. However, the CEC also reported a trend favoring nephrectomy alone for overall survival. Neither trend was statistically significant.

The CEC also determined that the required number of events to conduct an analysis of the recurrence-free survival endpoint was not met. The analysis of the overall survival endpoint is considered an interim assessment. According to Antigenics, it is unclear why opposing trends were observed between the primary endpoint and overall survival.

The company plans to conduct further review of the safety and efficacy data and meet with the Food and Drug Administration to discuss the data from the trial.

Shares of Antigenics closed at $2.97, down $2.14, or 41.9 percent, in heavy trading on the Nasdaq.

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King may need to conduct another trial to receive pediatric indication for Altace King Pharmaceuticals Inc.'s data supporting its supplemental New Drug Application, which seeks a pediatric indication for its hypertension drug Altace (ramipril), have been deemed insufficient by the Food and Drug Administration.

The data came from the TOPHAT trial, which King conducted in response to the agency's request for more information about Altace and its health benefits in the pediatric population.

"In light of this denial, the company plans to have further discussions with the FDA and provide additional supportive analyses," King said.

The firm added that it would conduct an additional trial if necessary, and that it would meet with the FDA to agree on the trial's design. If the trial proceeds and the final results are reported to the FDA by the third quarter of 2008, King said it believes it can meet the applicable regulations to gain another six months of market exclusivity for Altace. Product Naming

CancerVax releases results from failed Phase III skin cancer trials CancerVax Corp. released results from two Phase III skin cancer trials it discontinued last year.

Last October, the firm discontinued a trial of Canvaxin in patients with stage 3 melanoma following the recommendation of an independent Data and Safety Monitoring Board (DSMB). The DSMB found that the data were unlikely to show significant evidence of an overall survival benefit for patients who received Canvaxin as compared with those who received placebo.

In April 2005, the firm discontinued a Phase III trial of the drug in patients with stage 4 melanoma. This dicontinuation was based on a similar recommendation from a DSMB, CancerVax said.

Results from the trials, which were presented at the Society for Surgical Oncology's Annual Meeting in San Diego, concluded that Canvaxin is not efficacious as a post-surgical adjuvant treatment for advanced-stage melanoma.

Both trials were blinded and randomized, with patients receiving Canvaxin plus Bacillus Calmette-Guerin (BCG) vaccine, which is used to protect against tuberculosis and to treat bladder tumors or cancer, or BCG plus placebo. The primary endpoint for both trials was overall survival.

In the stage 3 study, which involved 1,160 patients, the five-year survival rate was 59.1 percent for Canvaxin-treated patients and 67.7 percent for placebo-treated patients. CancerVax noted that this difference was not statistically significant. Median disease-free survival was 42.6 months for Canvaxin-treated patients and more than 47 months for those who received placebo. The five-year disease-free survival rate was 52.1 percent for patients who received placebo and 47.2 percent for those who received Canvaxin.

In the stage 4 study, which involved 496 patients, the five-year survival rate was 39.6 percent for Canvaxin-treated patients and 44.9 percent for placebo-treated patients. Median disease-free survival was 8.3 months for patients who received Canvaxin and 7.2 months for those who took placebo. The five-year disease-free survival rate was 27.4 percent for Canvaxin and 20.9 percent for placebo. The difference between these results was not statistically significant, CancerVax said.

CancerVax conducted these trials in collaboration with Serono SA.

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Idenix amends protocol of valopicitabine trials due to adverse events Idenix Pharmaceuticals Inc. modified its Phase IIb trials of valopicitabine (NM283), an investigational hepatitis C treatment, to reduce the dose of the drug as a result of dose-related gastrointestinal side effects observed in both treatment-naive and treatment-refractory patients receiving 800 mg doses of the drug.

The original protocol of the 48-week trial enrolling treatment-naive patients included five randomized treatment arms. All treatment groups received valopicitabine, administered once-daily, in combination with Roche's Pegasys (peginterferon alfa-2a) 180 mcg/week. Four of the five arms received up to 800 mg/day of valopicitabine, while one arm received 200 mg/d.

The original protocol of the second trial, which enrolled treatment-refractory patients, called for treatment with valopicitabine 800 mg/d or 400 mg/d either alone or in conjunction with Pegasys or Pegasys plus ribavirin.

The amended protocol reduced the dose of valopicitabine from 800 mg/d to 200 mg/d or 400 mg/d. In the trial evaluating valopicitabine in treatment-naive patients, only patients with current serum HCV RNA levels below 600 IU/mL who are tolerating treatment may continue in the trial. In the trial evaluating the drug in treatment-refractory patients, only patients with serum HCV RNA levels below 1,000 IU/mL who are tolerating treatment may continue in the trial.

Researchers noted that the incidence of gastrointestinal adverse effects has been higher with the 800 mg/d dose of valopicitabine than with the 200 mg/d dose.

Based on preliminary data, approximately 16 percent of the treatment-naive patients and 5 percent of the treatment-refractory patients have discontinued participation due to gastrointestinal side effects. In the treatment-naive trial, there have been three serious adverse events attributed to valopicitabine; six serious adverse events attributed to valopicitabine have been reported in the treatment-refractory trial.

Shares of Idenix closed at $14.57, down $5.68, or 28.1 percent, in heavy trading on the Nasdaq.

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Study shows Eisai's Aricept improves cognition, preserves function in patients with severe AD Researchers concluded that Eisai Co. Ltd.'s Aricept (donepezil hydrochloride) improves cognition and preserves function in patients with severe Alzheimer's disease who live in nursing homes.

A double-blind, parallel-group clinical study included 248 patients with severe AD who were living in assisted-care nursing homes. Patients were randomized to receive placebo or Aricept at 5 mg/day for 30 days, and then up to 10 mg/d thereafter. The primary endpoints of the trial were changes from baseline to month six in the severe impairment battery (SIB) and modified Alzheimer's Disease Cooperative Study activities of daily living inventory for severe Alzheimer's disease (ADCS-ADL-severe).

Patients who received Aricept experienced greater improvements in SIB scores from baseline and less decline in ADCS-ADL-severe scores from baseline after six months of treatment than did the placebo-treated patients. In the intent-to-treat population, SIB scores improved an average of 2.6 points at six months for patients treated with Aricept, whereas they worsened an average of 1.9 points among the placebo group. Neither group showed an improvement in ADCS-ADL-severe scores at six months; however, patients in the group treated with Aricept experienced less of a decrease as compared with patients who received placebo (mean of 1.5 points vs. mean of 2.9 points, respectively).

The occurrence of adverse events was comparable between the groups; however, more patients discontinued treatment in the Aricept group than in the placebo group because of adverse events.

These data were published online by The Lancet, ahead of print.

Aricept, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc., is currently approved to treat patients with mild to moderate AD.

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Lilly's Cymbalta significantly reduces symptoms of generalized anxiety disorder, study finds Eli Lilly and Co.'s Cymbalta (duloxetine hydrochloride) significantly reduced core anxiety symptoms in patients with generalized anxiety disorder (GAD), a new study found.

The nine-week trial involved 513 patients with GAD who were randomized to 60 mg/day of Cymbalta (n=168), 120 mg/d of Cymbalta (n=170) or placebo (n=175).

The trial excluded patients who had received a diagnosis of major depression within the past six months, Lilly noted.

The study's primary endpoint was the effect on anxiety symptoms, as measured by the Hamilton Anxiety Scale (HAMA).

Results showed that Cymbalta significantly improved the core symptoms of anxiety (e.g., anxious mood, tension and fears) by 51 percent in those who took the 60 mg/d dose of the drug and by 50 percent in patients who took the 120 mg/d dose. In the placebo group, core anxiety symptoms improved by 32 percent.

Patients who took either dose of Cymbalta also had significantly greater response and remission rates relative to placebo-treated patients.

Furthermore, Cymbalta was shown to significantly reduce overall pain by 41 percent in the 60 mg group and by 37 percent in the 120 mg group compared with 16 percent in the placebo group.

"These data suggest that not only was Cymbalta able to significantly improve the core anxiety symptoms, but it also reduced painful physical symptoms associated with the disorder and improved functioning resulting in improved quality of life," said Dr. Christer Allgulander, lead study author.

Cymbalta is currently approved for the treatment of major depressive disorder or diabetic peripheral neuropathic pain in adults.

These data were presented on Saturday at the Anxiety Disorders Association of America's annual conference in Miami.

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Merck KGaA Merck KGaA said it will not raise its unsolicited offer to acquire Schering AG for approximately $17.2 billion. The firm's executive board concluded "that a higher price per Schering share is not justified in the view of Merck. ..." The board has therefore decided not to pursue the planned takeover. Separately, Schering said its board will support Bayer AG's approximately $19.53 billion takeover offer. "Joining forces of Schering and Bayer will form a leading specialized pharmaceutical company," said Dr. Hubertus Erlen, chairman of Schering's executive board.

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Eli Lilly and Co. Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. initiated a clinical study of a long-acting release formulation of Byetta (exenatide) injection to treat patients with type 2 diabetes following discussions with the Food and Drug Administration. The 30-week, open-label, noninferiority study will assess whether once-weekly Byetta LAR is at least as effective in improving glucose control as twice-daily Byetta. The study will include 300 patients with type 2 diabetes who cannot achieve adequate glucose control using diet and exercise with or without the use of oral diabetic agents. Researchers will evaluate changes in hemoglobin A1C levels, fasting blood glucose levels, body weight and safety parameters.

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Medtronic Inc. Medtronic Inc. received approval from the Food and Drug Administration for RestorePrime, an implantable neurostimulator for the treatment of chronic pain. RestorePrime is indicated to treat bilateral and complex pain in the trunk and/or limbs that is associated with failed back surgery syndrome, post-laminectomy pain, unsuccessful disc surgery or degenerative disc disease, as well as other conditions.

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Encysive Pharmaceuticals Inc. Encysive Pharmaceuticals Inc. said its next-generation selective endothelin receptor antagonist, TBC3711, has been placed on clinical hold by the Food and Drug Administration. According to Encysive, the FDA took this action because of an "unusual finding" in a rat that had been given TBC3711 intravenously. The company noted that the rat "had displayed abnormalities at baseline." Encysive is suspending all clinical testing of the oral and IV forms of the drug and plans to work on this issue with the FDA. In January, the firm began a 150-patient dosing trial of TBC3711 as a treatment for resistant hypertension, Reuters reported.

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