Biopeer

Gene therapy for Parkinson's disease set for clinical trials

A study, recently published in The Lancet, found that a gene-bearing virus injected into the midbrains of 12 patients suffering from Parkinson's disease showed motor function improvements. “The safety and effectiveness clearly indicate that this is something worth pursuing,” said Michael Kaplitt, neurological surgeon at New York-Presbyterian Hospital. The researchers used a harmless virus to transport a gene that codes for an enzyme, called glutamic acid decarboxylase, into neurons in the area of the brain called the subthalamic nucleus. The gene prompted the subthalamic cells to produce gamma-aminobutyric acid, which made the neurons settle down and restore motor function. The 12 subjects were monitored for a period of one year and their motor function showed up to 65% improvement. The researchers are hoping to have a full scale clinical trial for the gene therapy set by the year's end.

Peregrine Pharmaceuticals, a clinical stage biopharmaceutical company, recently announced the initiation of a new Phase II clinical trial designed to evaluate the safety and efficacy of its tumor necrosis therapy (TNT) agent – Cotara – in patients with glioblastoma multiforme (GBM), a deadly form of brain cancer. In a pilot study, Cotara has demonstrated a 58% increase in the expected median survival time in a group of 28 patients suffering from recurrent late stage glioblastoma multiforme. “We anticipate that positive data from this study, together with dosimetry and dosing data being collected in ongoing U.S. Cotara trials, will help us determine the optimal design of Phase III product registration trials,” said Steven W. King, president and CEO of Peregrine.

Generex Biotechnology Corporation recently announced at the 67th Scientific Sessions of the American Diabetes Association, that the company is initiating a Phase III clinical trial of Generex Oral-lyn, an oral insulin spray product. The six month trial would include 750 type 1 diabetes mellitus patients. “We enter this trial with a great deal of confidence that the results will validate the successful outcomes that patients have experienced in previous clinical trials,” said Anna Gluskin, president and CEO of Generex.

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Phase III clinical trial for obesity treatment underway

Orexigen Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of central nervous system disorders, with an initial focus on obesity, recently announced the initiation of the second study in its Phase III clinical trial program for its lead product candidate, Contrave as a treatment for obesity. The program includes a set of four registration trials evaluating a variety of obesity-related outcome measures. This trial is a 56-week study intended to assess both the safety and efficacy of Contrave in obese patients with type II diabetes. The trial will take place at approximately 40 centers nationwide and OREXIGEN plans to enroll 525 individuals. Patient recruitment is now underway.

Conor Medsystems, LLC, a wholly-owned subsidiary of Johnson & Johnson, presented its clinical trail results of the pivotal study for the CoStar® cobalt chromium paclitaxel-eluting coronary stent. Conor Medsystems is one of the principal investigators for the COSTAR II (CObalt Chromium STent with Antiproliferative for Restenosis) trial.

The COSTAR II trial compared the CoStar® stent with the Taxus Express(2) paclitaxel drug-eluting stent, and was designed to demonstrate non-inferiority at eight month follow up with respect to major adverse cardiac events (MACE) in patients with multi-vessel or single-vessel disease. In this trial, MACE was defined as a composite of clinically-driven target vessel revascularization (re-treatment), new myocardial infarction (heart attack or MI) related to the target vessel and cardiac death related to an intervened vessel. As a result of the outcomes, Conor Medsystems LLC recently terminated ongoing clinical trials with the CoStar® stent and halted the submission of its Pre-Market Approval application to the U.S. Food and Drug Administration for the product. Further, Conor Medsystems discontinued sale of the product through commercial partners in countries in Europe, Asia and Latin America where the CoStar® stent was already approved.

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Clinical trials make news

Researchers from the United States of America and from South Africa announced the launch of their collaborative effort to assess the efficacy of a possible HIV vaccine MRKAd5 HIV-1 with clinical trials. The trials are scheduled to last for four years and will be conducted on around 3,000 participants. Five sites in South Africa have been short listed as centers for the study. The trial is expected to allow the researchers to establish whether the vaccine will be successful in preventing the infection or in lowering the levels of HIV or both. This vaccine is based on clade B HIV while clade C virus is the prominent subtype in South Africa. Researchers will also observe whether the vaccine will work against this subtype too. Other areas the researchers are looking at include the efficacy of the vaccine during an HIV epidemic and in women. Merck & Co, Inc is the manufacturer of this trial vaccine. Optimism levels are high as phase I and phase II trials have shown that the vaccine is safe.


Meanwhile, researchers are also studying the ways in which phase I clinical trials of cancer can produce inaccurate results. Researchers from the University of Chicago found that tests on participants who took vitamins, minerals or other such supplements usually produced inaccurate data. The research team questioned 212 such participants on their use of alternative medications. The team found that 34 per cent took such supplements. The workings of these alternative medications are not yet known and they could mask or enhance the side effects of the experimental drug. Also, certain home remedies could be harmful when taken in combination with the drug. The researchers are now trying to encourage both doctors and participants to discuss such alternative medications.

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Clinical trials make waves

In order to prove the superiority of its cervical cancer vaccine Cervarix, GlaxoSmithKline (GSK) has decided to conduct a clinical trial. The trial will compare the efficacy of Cervarix against its rival Merck’s Gardasil. The trial will study the immune responses the vaccine produces against HPV 16 and 18 in 1,000 women between the ages of 18 and 26 years for two years. The makers of Cervarix believe that a new additive they have used in their vaccine stimulates higher levels of antibodies, giving them an edge over Gardasil. The trial also aims to compare the immune responses of the vaccines to HPV 31 and 45.

In a related development, scientists from the Joslin Diabetes Center, Boston, USA, are launching a clinical trial for type 2 diabetes patients. It will study whether lowering blood glucose levels with the anti-inflammatory drug salsalate will help these patients. If the study results are positive, it can even lead to the development of an inexpensive treatment for type 2 diabetes.

Meanwhile, a recent study from the stables of consulting firm AT Kearney has found that India is the second-most favored destination for clinical trials with only China ahead of it. Factors like a large number of willing patients, quick enrollment processes and possibility of lowering costs by even 40 to 60 per cent tilted the scale in India’s favor. However, for India to become the first on the list, it needs to address basic issues like poor infrastructure and the absence of a strong network for hospitals. Once this is done, India’s share in clinical trials will definitely increase from the current share of 5 to 10 per cent.

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Vaccines bring hopeful news

Continuing its efforts to hinder the spread of AIDS, Uganda has launched trials for a HIV vaccine that will check the mother-child transmission of the virus during breastfeeding. The vaccine has been named Alvac-HIV. The trial is currently in its phase I randomized double-blind stage where 14 babies have been given either the vaccine or a placebo as a control. In this phase, the researchers intend to find out whether the vaccine is safe for babies. Once this is established, they will test its efficacy in stopping the transmission. So far, the trial has met with great success. The final results will be out in mid-2007.

Meanwhile, scientists from America’s National Institutes of Health have developed a vaccine that will destroy the malaria-causing parasite in the mosquito. When the malaria vaccine is administered to a person, it brings about certain changes in his or her immune system. Then, when the mosquito bites a vaccinated person, these changes will eradicate the parasite from the mosquito’s digestive tract. With this vaccine, the researchers aim to make mosquitoes in a particular area free of the parasite so that they cannot spread malaria.

Also, a study conducted at the University of California San Francisco, USA, has determined that a therapeutic cancer vaccine extends the life span of men with asymptomatic metastatic hormone refractory prostate cancer. The vaccine, named sipuleucel-T, proved to hinder the progression of the disease in a double-blind, placebo-controlled phase III clinical trial conducted on 127 patients. Those who received the vaccine had a median overall survival of 25.9 months while it was 21.4 months for the others. The treatment did not have any severe side effects either. With treatment options for this disease generally being limited, the study has renewed hope for these patients.

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Clinical trials boost hopes for those suffering from HIV and chronic ailments

Clinical trials for different types of drugs are in full swing in India. In Mumbai, research in microbicides is at the clinical stage at the National Institute for Research in Reproductive Health (NIRRH). A microbicide is any substance that can substantially reduce transmission of sexually transmitted infections, when applied either in the vagina or rectum.

Research in the area of microbicides is essential as 40 per cent of the total HIV/ AIDS affected population in India is women. Per the Director, NIRRH, Mumbai “The growing feminisation of the AIDS pandemic and the urgent need for a female-controlled method have made prevention of HIV infection through vaginal exposure the top priority for research. Although, trials till now have shown an efficacy of only about 40-60 per cent, even a partially effective microbicide could avert more than 2 million HIV infections over a three-year span.

Meanwhile, Glenmark Pharma, an Indian pharmaceutical company, has applied for Phase-I clinical trials in Europe, for GRC 6211, its leading vanniloid receptor [VR1] antagonist compound for a range of pain indications like osteoarthritis, dental pain, neuropathic pain and urinary incontinence. The Phase I study will be conducted using single and multiple oral doses with the objective of assessing safety and bioavailability of GRC 6211 in healthy human beings. Glenmark is also in discussions for licensing partners for this compound. The company is targeting 2011 as the year of launch and aims to be an early launcher in this class. Incidentally, other molecules in the same category currently under development include: Merck's lead molecule which has progressed to Phase II, GSK's molecule presently in Phase II and Pfizer's in-licensed compound from Renovis, which is undergoing pre-clinicals trials.

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Enduring attempts to combat cancer

Scientists at the Vanderbilt-Ingram Cancer Center have developed a new mouse model for pancreatic cancer that exhibits similar properties to a human tumor. Hal Moses and his team developed this improved model by combining a previous model called Kras with type II TGF receptor. Cell biology suggests loss of TGF signals causes a molecular imbalance on the cell growth leading to unrestrained cell proliferation and tumor formation. Applying this theory, genetically engineered mice with pancreatic cancer have been created for providing researchers opportunities to investigate on various treatments and screening methods to fight one of the most deadly cancers.

In another development, researchers at the University of Texas M D Anderson Cancer Center have discovered a new vascular targeting agent called Trojan Horse that shows hopes for treating bone tumors. A pre-clinical study conducted on mice revealed that Trojan Horse successfully prevented the development of bone tumors in 50 per cent mice. Although the experiment is still underway but scientists are hopeful that the success on mice could be a promising indication to tackling cancers in bones such as breast, multiple myeloma, lung and renal cell.

Peregrine Pharmaceuticals Inc, a clinical stage biopharmaceutical company is initiating its phase lb clinical trial to evaluate its anti-phospholipid immunotherapy agent, bavituximab given in combination with common cancer chemotherapy agents. The preclinical trial had suggested that agent bavituximab was very effective when combined with normal chemotherapy. The human trial is expected to enroll up to 12 patients who will be observed for 8-week duration at three clinical sites in India. The trial will check bavituximab for safety and tolerability when administered with standard chemotherapy regimens.

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Drugs step in to fight obesity

Cashing in on the growing awareness about obesity, three companies are testing drugs that will combat obesity.

Amylin Pharmaceuticals Inc declared the results of its Phase 2 extension study of its drug pramlintide. According to the company, a 52-week study of pramlintide showed that the drug decreased body weight by 7 to 8 per cent in patients when compared to the 1 per cent reduction in patients on a placebo. Amylin is now planning five clinical studies in order to test the efficacy of pramlintide when taken in combination with other compounds.

Meanwhile, another pharmaceutical company Vivus Inc presented encouraging results for an investigational oral treatment for obesity at the North American Association for the Study of Obesity (NAASO) 2006 Annual Scientific Meeting at Boston, USA. A double-blind, randomized, placebo-controlled trial of Qnexa involving 200 participants was conducted to test the efficacy. The results showed that patients on the drug who completed twenty-four weeks of the trial achieved an average weight loss of 26 pounds while the placebo group achieved an average of 7 pounds. The former group also lost an average 11.1 per cent of baseline body weight while the latter averaged 2.8 per cent.

Orexigen Therapeutics Inc too presented data at the NAASO meeting that established that Excalia aids significant weight loss. In a six-month, double-blind, phase 2a clinical study, it was found that participants on Excalia who completed the blinded 24-week phase lost on average 9.2 per cent of their weight from baseline while those on placebo averaged an 0.4 per cent weight loss from baseline. Also, weight loss continued through an additional 24-week open-label period.

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India emerging as a hub for clinical trials

An enriched pool of highly qualified and skilled medical professionals, suited for R &D activities, a large populace that is a blend of different races and limited health care make India a perfect ground for clinical trials. Currently, India accounts for USD 285 million of outsourced clinical trials market.

This is true even in the case of research and development of stem cells. Most of these trials are via autologous transfer, or those that use adult stem cells taken from the patients themselves. Interestingly, embryonic stem cells are currently only used in fundamental research and it will be 5-8 years at the very least, before they can be put to use in clinical trials. Since January 2006, stem cell trials for the treatment of stroke, spinal cord injury, leg ischemia and myocardial infarction are running in India. Since the start of these trials, many patients have already been treated using bone marrow derived stem cells. Similarly, the LV Prasad Eye Institute, Hyderabad has been successful in using stem cells to treat corneal opacity and blindness. They have passed the clinical trail stage and treated over 250 patients with a 70 per cent success rate.

Another instance of this is the case of Synexus India, which has signed up two-phase III studies from a top pharmaceutical company, and is expected to announce further studies soon. Both phase III trials in India involve research into cardiac therapy in treatment naïve as well as previously treated patients.

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FDA approves two generic drugs and one clinical trial

The generic drugs industry got another boost when the US Food and Drug Administration (FDA) approved the generic versions of two more drugs.

KV Pharmaceutical Company has received approval from the FDA to market its Diltiazem HCl ER Capsules in six strengths. KV will market Diltiazem in the strengths of 120mg, 180mg, 240mg, 300mg, 360mg and 420mg through its subsidiary ETHEX Corporation as soon as possible. Also, since it is the first company to be allowed to market the 420mg strength dosage, KV hopes to get six months exclusivity on it. Diltiazem is the generic version of Tiazac, a product from the stable of Forest Pharmaceuticals, Inc. Tiazac is a calcium channel blocker used to treat hypertension and angina.

Another approval the FDA has granted is to Mylan Pharmaceuticals Inc, a subsidiary of Mylan Laboratories Inc, for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets. The strengths granted final approval are 25mg, 100mg and 200mg and Mylan is eligible for a 180-day market exclusivity for them. Topiramate 50mg has been granted tentative approval. Topiramate Tablets are the generic version of Topamax Tablets, manufactured by Ortho-McNeil.

Meanwhile, the FDA has cleared Iomai Corporation to begin a trial that will compare the immune response of the needle-free, patch-based influenza vaccine and the traditional vaccine. The trial volunteers will either be injected with a single dose of the traditional vaccine or will be given the Iomai patch to wear. Blood tests will then be conducted to analyze the two methods. Around 300 volunteers are expected to be enrolled in this trial, which will commence later this month.

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