In the pipeline

Drugs in Development and New Indications

New Adjuvant Yields Positive Results

GlaxoSmithKline�s investigational human papillomavirus (HPV) 16/18 L1 vaccine has been eliciting positive results in recent trials, most likely due to its added model adjuvant composed of aluminum plus 3-deacylated monophosphoryl lipid A (AS04). Over a 3.5 year postvaccination period, the drug produced a stronger immune response compared to the same vaccine that used aluminum alone. The vaccine specifically targets HPV 16 and HPV 18, the two strains responsible for 70% of cervical cancer cases. The product is currently in phase 3 trials with an enrollment of over 28,000 women worldwide.

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Shocking Alternative for Migraineurs

Relief is on the way for those of the 28 million migraineurs who have had little luck with traditional therapies. Boston Scientific Corporation has received approval from the US Food and Drug Administration (FDA) to commence with studies involving the use of their occipital nerve stimulation device (Precision) for the treatment of refractory migraine headache. In the upcoming trials, the neurostimulator will administer electrical impulses to the occipital nerves found under the skin at the back of the neck. The device has already been approved by the FDA for the treatment of chronic pain with spinal cord stimulation. It is currently the smallest, rechargeable neurostimulator on the market.

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Curious Cure for Chronic Pain

While the exact link remains unclear, an innovative drug currently being used to treat narcolepsy has proved effective in reducing the widespread musculoskeletal pain, fatigue, and body soreness of patients suffering from fibromyalgia. Sodium oxybate (Xyrem), currently approved by the FDA to treat cataplexy in patients with narcolepsy, has been found to alleviate typical symptoms of the chronic pain disorder, and even improve overall quality of sleep. Recent clinical trials funded by Orphan Medical, Inc, have also suggested that at high dosages, the drug reduces the body tenderness that often accompanies physician examinations. There is currently no medication approved by the FDA for the treatment of fibromyalgia.

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Battling Obesity

In recent phase 3 trials, Sanofi-Aventis�s investigational selective cannabinoid-1 receptor blocker, rimonabant (Acomplia), has shown a significant reduction in waist circumference and improvement in a range of metabolic risk factors in patients with atherogenic lipid abnormalities. Participants were given varying levels of the drug and were placed on a low-calorie diet; weight reduction took place mostly within the first 9 months of the study and no weight gain was reported thereafter. Improvements were made in atherogenic markers, plasma triglycerides, plasma high-density lipoprotein cholesterol, and adiponectin levels. While pharmacotherapy will by no means eliminate the problem as a whole, it shows promise as a new approach in improving the cardiovascular risk of overweight and obese patients with dyslipidemia. The company hopes to bring the drug to the market in early 2006.

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Diabetes Drug With a Heart

Already approved by the FDA in 1999 for use as an insulin sensitizer, Takeda Pharmaceuticals North America, Inc�s, oral antidiabetic agent pioglitazone hydrochloride (Actos) has been shown to significantly reduce the risk of heart attack, stroke, and death in high-risk type 2 diabetic patients who have previously suffered a heart attack. The study of 5,328 patients, called the prospective pioglitazone clinical trial in macrovascular events (PROactive), was the first of its kind in using a glucose-lowering agent in order to analyze total mortality and macrovascular activity. Out of the PROactive group, 2,445 patients with type 2 diabetes and a history of heart attack reduced the risk of recurrence by 28%, and the risk of acute coronary syndrome by 37%.

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New HIV Efforts

Continuing with the ongoing effort to find effective pharmacotherapy for human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome, a recent 48-week pivotal phase 3 trial tested Boehringer Ingelheim�s tipranavir capsules (Aptivus) combined with ritonavir (Aptivus/r) against a group of ritonavir-boosted comparator protease inhibitors (PIs). The former group reportedly had a 33.6% decrease in viral load, in comparison to a 15.3% decrease in the latter group. Treatment with the tipranavir/ ritonavir combination also showed an increase in the amount of immune cells than the alternative PIs. Tripranavir was granted accelerated review by the FDA in June 2005 for the treatment of HIV. Long-term data is still needed before the product can be considered for traditional approval, or for use with ritonavir.

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Unique RA Therapy

Phase 2 trials of Johnson & Johnson�s investigational drug golimumab (CNTO-148) have shown a significant reduction in the signs and symptoms of patients suffering from rheumatoid arthritis, who are also taking methotrexate. The drug, which has so far shown a unique potency in comparison to other similar therapies, had median trough levels that were considered to be well above the minimal clinically effective level. Researchers postulate that this is partly due to its ability to bind more tightly to tumor necrosis factor (TNF) receptors and also to bind to a different TNF epitope than other drugs. If the therapy is approved by the FDA, it may used as an alternative for patients who do not respond to other treatments currently on the market.

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