Archive for January, 2008

New reports on picoplatin from Poniard

Tuesday, January 29th, 2008

Poniard PharmaceuticalsUS-based Poniard Pharmaceuticals has presented encouraging safety data from a Phase I dose-escalation study of picoplatin for the treatment of colorectal cancer.

The data presented at the 2008 Gastrointestinal Cancers Symposium included safety data from a Phase I study of picoplatin in combination with 5-fluorouracil (5FU) and leucovorin (LV) as a first-line treatment for metastatic colorectal cancer (mCRC). The Phase I study seeks to establish the maximum tolerated dose of picoplatin and provide information on the safety of picoplatin when combined with 5FU and LV.

Jerry McMahon, chairman and CEO of Poniard, said: “These study results suggest that picoplatin does not cause severe neurotoxicity, as is commonly seen in mCRC patients treated with the regimen of 5FU and LV with oxaliplatin. Picoplatin has demonstrated both good tolerability and no severe neuropathies when combined with 5FU and LV. We believe picoplatin has the potential to be a preferred platinum for the treatment of colorectal and other cancer indications.”

Picoplatin

Picoplatin is a cytotoxic platinum compound in clinical development for the treatment of patients with solid tumors. It causes apoptosis (cell death) by binding to DNA and interfering with DNA replication and transcription.

Picoplatin is a new generation platinum chemotherapy agent that has an improved safety profile compared to existing platinum-based chemotherapeutics and was designed to overcome platinum resistance. Picoplatin has been evaluated in more than 750 patients and has demonstrated activity in multiple indications with no evidence of significant kidney, nerve toxicity or hearing loss.

Potential Benefits

Platinum drugs destroy cancer cells by binding to DNA. This causes damage that triggers apoptosis (programmed cell death) if the damage is too severe to be repaired by intracellular systems.

However, currently available platinum therapies have significant shortcomings, including toxicities and drug resistance (both intrinsic and acquired) that limit their use.

Picoplatin, which was designed to overcome platinum resistance associated with the treatment of solid tumors, has several potential benefits:

  • Broadly applicable for treatment of solid tumors
  • Demonstrated mechanism for use with new therapies
  • May provide safer alternative to existing platinums
  • Addresses unmet medical need by treating platinum-sensitive, -resistant and -refractory disease
  • Large and growing market for platinum products

Poniard gets Fast Track designation for lung cancer treatment

Poniard Pharmaceuticals has been granted Fast Track status by the FDA for its lead product candidate, picoplatin, for the second-line treatment of refractory or resistant small cell lung cancer.

Picoplatin is currently being studied in the pivotal Phase III SPEAR (study of picoplatin efficacy after relapse) trial in small cell lung cancer (SCLC), which is evaluating overall survival as the primary endpoint and is being conducted under a special protocol assessment agreement with the FDA.

Poniard’s updated data from its Phase II SCLC trial confirmed and extended a median overall survival of 27 weeks (based on an analysis of 63 patients), which compares favorably to a median survival of approximately 17 to 22 weeks for patients who receive other second-line chemotherapy, according to the 2007 national comprehensive cancer network practice guidelines.

“Our receipt of Fast Track designation has the potential to accelerate the development of picoplatin for the treatment of small cell lung cancer, a difficult-to-treat disease, and a patient population with very limited treatment options,” said Jerry McMahon, chairman and CEO of Poniard.

“We are focused on executing our ongoing Phase III SPEAR trial to facilitate the expeditious filing of a new drug application and obtaining the approvals required to make picoplatin available to this severely underserved patient population.”

Posted in Cancer drugs, Drugs and Medications, Poniard Pharmaceuticals, Research | No Comments »

Taking an antidepressant? Do NOT stop suddenly!

Saturday, January 26th, 2008

AntidepressantsIf you want to stop taking an antidepressant, it’s important to speak with your doctor first, the American Academy of Family Physicians says. The doctor may recommend weaning your body off the medication gradually.

People who stop an antidepressant too quickly may trigger a host of symptoms that doctors call antidepressant discontinuation syndrome. Symptoms may include:

  • Anxiety.
  • Feelings of depression or sadness.
  • Moodiness and irritability.
  • Tiredness.
  • Headaches and dizziness.
  • Nausea and vomiting.
  • Diarrhea.

If an antidepressant is causing an unpleasant side effect, your doctor may opt to lower your dose or prescribe a different type of antidepressant altogether.

What are antidepressants?
Antidepressants are medicines used to help people who have depression. Most people with depression get better with treatment that includes these medicines.

How do antidepressants work?
Most antidepressants are believed to work by slowing the removal of certain chemicals from the brain. These chemicals are called neurotransmitters. Neurotransmitters are needed for normal brain function. Antidepressants help people with depression by making these natural chemicals more available to the brain.

How long will I have to take an antidepressant?
Antidepressants are typically taken for at least 4 to 6 months. In some cases, patients and their doctors may decide that antidepressants are needed for a longer time.

What are the different kinds of antidepressants?
Antidepressants are put into groups based on which chemicals in the brain they affect. There are many different kinds of antidepressants, including:

Selective serotonin reuptake inhibitors (SSRIs)

  • citalopram (brand name: Celexa)
  • escitalopram (brand name: Lexapro)
  • fluoxetine (brand name: Prozac)
  • paroxetine (brand names: Paxil, Pexeva)
  • sertraline (brand name: Zoloft)

[ Antidepressants on CanadianMedsWorld ]

These medicines tend to have fewer side effects than other antidepressants. Some of the side effects that can be caused by SSRIs include dry mouth, nausea, nervousness, insomnia, sexual problems and headache.

Tricyclics

  • amitriptyline (brand name: Elavil)
  • desipramine (brand name: Norpramin)
  • imipramine (brand name: Tofranil)
  • nortriptyline (brand name: Aventyl, Pamelor)

Common side effects caused by these medicines include dry mouth, blurred vision, constipation, difficulty urinating, worsening of glaucoma, impaired thinking and tiredness. These antidepressants can also affect a person’s blood pressure and heart rate.

Serotonin and norepinephrine reuptake inhibitors (SNRIs)

  • venlafaxine (brand name: Effexor)
  • duloxetine (brand name: Cymbalta)

Some common side effects caused by these medicines include nausea and loss of appetite, anxiety and nervousness, headache, insomnia and tiredness. Dry mouth, constipation, weight loss, sexual problems, increased heart rate and increased cholesterol levels can also occur.

Norepinephrine and dopamine reuptake inhibitors (NDRIs)

  • bupropion (brand name: Wellbutrin)

Some of the common side effects in people taking NDRIs include agitation, nausea, headache, loss of appetite and insomnia. It can also cause increase blood pressure in some people.

Combined reuptake inhibitors and receptor blockers

  • trazodone (brand name: Desyrel)
  • nefazodone (brand name: Serzone)
  • maprotiline
  • mirtazpine (brand name: Remeron)

Common side effects of these medicines are drowsiness, dry mouth, nausea and dizziness. If you have liver problems, you should not take nefazodone. If you have seizures, you should not take maprotiline.

Monamine oxidase inhibitors (MAOIs)

  • isocarboxazid (brand name: Marplan)
  • phenelzine (brand name: Nardil)
  • tranlcypromine (brand name: Parnate)

MAOIs are used less commonly than the other antidepressants. They can have serious side effects, including weakness, dizziness, headaches and trembling. Taking an MAOI antidepressant while you’re taking another antidepressant or certain over-the-counter medicines for colds and flu can cause a dangerous reaction. Your doctor will also tell you what foods and alcoholic beverages you should avoid while you are taking an MAOI. You should not take an MAOI unless you clearly understand what medications and foods to avoid. If you are taking an MAOI and your doctor wants you to start taking one of the other antidepressants, he or she will have you stop taking the MAOI for a while before you start the new medicine. This gives the MAOI time to clear out of your body.

Will antidepressants affect my other medicines?
Antidepressants can have an effect on many other medicines. If you’re going to take an antidepressant, tell your doctor about all the other medicines you take, including over-the-counter medicines and herbal health products (such as St. John’s wort). Ask your doctor and pharmacist if any of your regular medicines can cause problems when combined with an antidepressant.

Posted in Antidepressants, Drugs and Medications, Taking medicines: Rules and tips, Warnings! | No Comments »

Metformin is effective in reversing weight gain

Sunday, January 20th, 2008

MetforminTreatment with metformin or lifestyle changes promoting exercise and a healthy diet are both effective in reversing the weight gain associated with antipsychotic medications, according to a clinical trial conducted in China. However, a combination of the two approaches is even better.

Metformin, sold under various trade names such as Glucophage, is primarily used to lower blood sugar in patients with type 2 diabetes.

Dr. Jing-Ping Zhao and associates at the Mental Health Institute of the Second Xiangya Hospital in Changsha note that by lowering glucose production in the liver, metformin prevents weight gain and decreases insulin resistance.

However, its effect on the metabolic complications of antipsychotic medication has not been established, the researchers point out in the Journal of the American Medical Association.

Zhao’s group enrolled 128 adults with schizophrenia who gained more than 10 percent of their body weight after taking an antipsychotic drug for 1 year. They were randomly assigned to receive metformin, placebo, lifestyle interventions plus metformin, or lifestyle interventions plus placebo.

The lifestyle intervention included an educational program, the American Heart Association’s step 2 diet and daily moderate exercise for at least 30 minutes.

“To keep patients with schizophrenia compliant with treatment, they all had to be under the care of their parents or another adult caregiver,” Zhao told Reuters Health.

The subject’s average body mass index was 24.5 at the beginning of the study and the average weight was 64.6 kg (142.4 lbs).Body mass index (BMI) is the ratio of height to weight commonly used to classify individuals as underweight, overweight or in a normal weight range. A BMI of 24.5 is at the top end of the normal range.

After 12 weeks, all measured outcomes had worsened in the placebo group, including a weight gain of 3.1 kg (6.8 lbs).

In the metformin group, all outcomes had improved; subjects lost an average of 3.2 kg (7.1 lbs). Subjects in the lifestyle intervention group lost 1.4 kg (3.1 lbs).

However, the benefits of combined treatment were significantly greater than those achieved by either intervention alone. Weight loss in the combined treatment group averaged 4.7 kg (10.4 lbs).

“We recommend that lifestyle intervention plus metformin be considered first for those with weight gain. If patients cannot tolerate or adhere poorly to lifestyle intervention, they should consider metformin alone,” Zhao advised.

“Of course, the safety of metformin must be ensured,” Zhao stressed.

The team is currently engaged in the next stage of their research, he added. “We are studying the efficacy of long-term metformin and lifestyle intervention, and different doses of metformin, on antipsychotic-induced weight gain.”

Diabetes Drug May Cut Med-Related Weight Gain

Improved diet, more exercise and the diabetes medication metformin can help people suffering with schizophrenia control the weight gain that typically accompanies their medications, a Chinese study suggests.

Three months of both medication and lifestyle change resulted in a loss of two centimeters around the waist as well as improvement in other health measures, such as insulin resistance, the researchers report in the Jan. 9/16 issue of the Journal of the American Medical Association.

Metformin is typically prescribed to help control blood sugar levels in people with diabetes. Previous research has shown that metformin can prevent weight gain in people with diabetes and may help manage weight in some overweight people.

Doctors prescribe atypical antipsychotic (AAP) medications to manage a variety of psychotic disorder and behavioral disturbances, including schizophrenia. However, the drugs often also affect the body’s metabolism, resulting in unhealthy cholesterol levels, weight gain and glucose intolerance.

A team based at the Mental Health Institute of the Second Xiangva Hospital, Central South University, China, tested the effect of metformin and lifestyle changes, together and separately, on the weight and insulin levels of 128 adults with schizophrenia. All the participants had gained at least 10 percent of their body weight after starting antipsychotic medications.

The participants were randomly assigned to one of four groups for 12 weeks, while continuing their medication: One group received a placebo or sugar pill; the second one received 750 milligrams per day of metformin; the third received 750 milligrams per day of metformin with lifestyle intervention; and the fourth went through the lifestyle intervention alone. The lifestyle interventions included health education, diet and exercise.

An analysis of the data found that patients in the combination group and patients who took either metformin or engaged in lifestyle change all reduced their weight, body-mass index (a measure of height and weight), waist circumference, insulin levels and insulin resistance.

The participants who took metformin and changed their diet and exercise saw a decrease of 1.8 in their body-mass index, 3.6 in insulin resistance and lost two centimeters in waist circumference. Metformin alone resulted in an average loss of 1.2 in body-mass index, 3.5 in insulin resistance and 1.3 centimeters from the waist. Those who only exercised and changed their diet saw a loss of 0.5 in body-mass index and 1.0 in insulin resistance, but they were no slimmer at the waist. People who took the placebo continued to increase in body mass, waist and insulin resistance, said the researchers.

Metformin

Brand Names: Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet

What is metformin?

Metformin is an oral diabetes medicine that helps control blood sugar levels.

Metformin is for people with type 2 (non-insulin-dependent) diabetes.

Metformin is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Metformin may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about metformin?
Do not use metformin if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking metformin, tell your doctor if you have liver disease or a history of heart disease.
Some people have developed a life-threatening condition called lactic acidosis while taking metformin. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

If you need to have any type of x-ray or CT scan using a dye that is injected into a vein, you may need to temporarily stop taking metformin. Be sure the doctor knows ahead of time that you are using metformin.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar.

What should I avoid while taking metformin?

Avoid drinking alcohol while taking metformin. Alcohol lowers blood sugar and may increase the risk of lactic acidosis while you are taking this medicine.

Metformin side effects
Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting. Stop using metformin and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • headache or muscle pain;
  • weakness; or
  • mild nausesa, vomiting, diarrhea, gas, stomach pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Posted in Diabetes drugs, Drugs and Medications | No Comments »

Daily Cialis doses: How to take these sex pills

Wednesday, January 9th, 2008

Cialis pills onlineEli Lilly and Co on Tuesday said U.S. regulators approved once-daily use of two low-dose forms of its Cialis anti-impotence drug, offering greater convenience for men expecting frequent sexual activity.

The Indianapolis drugmaker said the once-daily formulations, in dosages of 2.5 milligrams and 5 milligrams, will allow men to attempt sexual activity any time between doses.

“In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy,” Lilly said in a release.

The low-dose daily formulations, already approved in parts of Europe, “may be most appropriate for men with erectile dysfunction who anticipate more frequent sexual activity (e.g. twice weekly),” Lilly said.

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The company said the low-dose formulations provide “a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity.”

The treatment, which has global annual sales of $1.2 billion, has been available in the United States since 2003 in dosages of 5 milligrams, 10 milligrams and 20 milligrams, and taken as needed. Those dosages provide effectiveness for up to 36 hours.

Company spokeswoman Keri McGrath said no dosage forms of the medicine, including the newly approved lower ones, are appropriate for heart patients who take nitrates, including nitroglycerin.

Members of the class of drugs to which Cialis belongs — including Pfizer Inc’s rival Viagra and GlaxoSmithKline Plc’s Levitra — can dangerously lower blood pressure when used alongside nitrates.

The drugs, used by millions of men worldwide, also carry new warnings about potential risk of sudden hearing loss.

Shares of Lilly were up $1.05, or 1.9 percent, to $55.60 in morning trading on the New York Stock Exchange, in line with a 2 percent advance for the drug sector.

Cialis Information

Generic Name: tadalafil

Brand Names: Cialis

What is tadalafil?

Tadalafil relaxes muscles and increases blood flow to particular areas of the body.

Tadalafil is used to treat erectile dysfunction (impotence).

Tadalafil may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about tadalafil?
Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (”poppers”). Taking tadalafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Tadalafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking tadalafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether tadalafil is the actual cause of vision loss.
Stop using tadalafil and get emergency medical help if you have sudden vision loss.

How should I take tadalafil?

Take tadalafil exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.
Take this medication with a full glass of water.

Tadalafil can be taken with or without food.

Tadalafil is usually taken only when needed, just before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor’s instructions.
Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Store this medication at room temperature away from moisture and heat.

Posted in Anti-impotence drugs, Drugs and Medications, Eli Lilly, Erectile dysfunction, Taking medicines: Rules and tips | No Comments »

Fake Viagra and Cialis anti-impotence drugs

Wednesday, January 9th, 2008

Fake viagra pillsFrench customs officials have intercepted a shipment of 224,000 fake Viagra and Cialis anti-impotence pills worth 2.4 million euros ($3.5 million), the Budget Ministry said on Monday.

The copies of the best-selling drugs were found on December 18 during a search at the French capital’s main air hub at Roissy, in a freight cargo on its way to Brazil from India.

“Branded Powergra and Erectalis, each box contained, in fact, four tablets in the characteristic shape and color of Viagra or Cialis pills,” Budget Minister Eric Werth’s office, which is also in charge of customs, said in a statement.

“The companies Pfizer and Eli Lilly, which respectively own the Viagra and Cialis brands, quickly confirmed the counterfeit nature of these products and the 224,000 pills were seized,” Werth’s office added.

Fake Viagra maker given 10-year prison term

A man has been given a 10-year prison sentence for producing millions of fake anti-impotence pills.

Viagra, the anti-impotence drug, is made by Pfizer. [file photo]

Wang Weiping was also fined 2 million yuan (US$250,000) in a first ruling on Monday at Shaoxing Intermediate People’s Court in East China’s Zhejiang Province.

The 34-year-old, a legal worker at Kangdeli Health Care Co Ltd in Xinchang County of the province, was arrested in November last year on suspicion of producing and selling counterfeit drugs.

A total of 381,000 fake Viagra pills and 1.4 million counterfeit Cialis tablets, worth a combined total of 241 million yuan (US$29 million) on the market, were also seized from workshops at Kangdeli Health Care, according to a release from the court.

Viagra is produced by the New York-based Pfizer Pharmaceuticals, while Cialis is manufactured by Indianapolis-based Lilly Icos LLC. Both are well-known drugs to treat impotence.

Some of the fake pills were found to contain medical starch, which does not have any curative effect and others had too much sildenafil, the main ingredient of Viagra, and is detrimental to health in large doses, said the release.

Workshops to make the fake drugs were also found in Guannan County of Jiangsu Province, Zhejiang’s neighbouring province.

All counterfeit pills, production machines and materials to make the fake drugs were confiscated.

Wang began making the fake pills in Shaoxing in April last year, and established another manufacturing base at Guannan in Jiangsu Province in June.

Local police and drug administration officials uncovered the case during a crackdown on the production of fake pills.

No counterfeit drugs have actually been found in the marketplace, said Zhang Guojing, director of the Shaoxing Food and Drug Administration.

Wang’s operation is the biggest, in terms of the financial worth of the pills, to have been uncovered in Zhejiang Province.

Erectile dysfunction drugs such as Viagra and Cialis were approved by the Ministry of Health and State Food and Drug Administration as prescription drugs in 1999.

In December last year, seven people in Zhengzhou in Central China’s Henan Province were accused of selling 9.7 million fake tablets of Viagra.

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Police bust online Viagra gang

The leader of a gang selling fake Viagra over the internet has been given a four and a half year jail sentence.

Ashish Halai, 33, ordered fake Viagra tablets from suppliers in China and Mexico for 25p each and sold them for as much as ?20 online to people in the US and Europe who were too embarrassed to go to their doctor.

Three other members of the gang were also found guilty and will be sentenced later.

The case came to light after an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA), which estimated that the gang netted at least ?2m from the scam.

Mick Deats, head of enforcement at the MHRA, said: “The MHRA treats every report of a counterfeit medicine as a serious incident. This successful prosecution should serve as a clear signal to those contemplating the supply of counterfeit medicines.

“The public are strongly advised to avoid buying medicines online, where the risk of being provided with counterfeit medicines is greatly increased.”

Halai is a chemist who sold his practice in Bayswater, London but continued to use the name to sell herbal supplements.

The court heard that Halai began selling fake anti-impotence drugs in 2002 passing them off as Viagra and Cialis. He packaged the drugs so skilfully that experts said it would take a trained eye to spot the difference.

Police seized over ?1.5m worth of the fake drugs when they swooped on the gang. The drugs were imported using business courier services and were disguised as pet supplements.

Posted in Anti-impotence drugs, Drugs and Medications, Eli Lilly, Pfizer | No Comments »

Cocain vaccine is coming soon

Friday, January 4th, 2008

cocaineTwo Baylor College of Medicine researchers in Houston are working on a cocaine vaccine they hope will become the first-ever medication to treat people hooked on the drug. “For people who have a desire to stop using, the vaccine should be very useful,” said Dr. Tom Kosten, a psychiatry professor who is being assisted in the research by his wife, Therese, a psychologist and neuroscientist. “At some point, most users will give in to temptation and relapse, but those for whom the vaccine is effective won’t get high and will lose interest.”

The vaccine, currently in clinical trials, stimulates the immune system to attack the real thing when it’s taken.

The immune system — unable to recognize cocaine and other drug molecules because they are so small — can’t make antibodies to attack them.

To help the immune system distinguish the drug, Kosten attached inactivated cocaine to the outside of inactivated cholera proteins.

In response, the immune system not only makes antibodies to the combination, which is harmless, but also recognizes the potent naked drug when it’s ingested. The antibodies bind to the cocaine and prevent it from reaching the brain, where it normally would generate the highs that are so addictive.

“It’s a very clever idea,” says David Eagleman, a Baylor neuroscientist. “Scientists have spent the last few decades figuring out reward pathways in the brain and how drugs like cocaine hijack the system. It turns out those pathways are difficult to rewire once they’ve seen the drug. But the vaccine just circumvents all that.”

Kosten asked the Food and Drug Administration in December to green-light a multi-institutional trial to begin in the spring and is awaiting a response.

Approval would mark a breakthrough in the treatment of cocaine addiction, which now mostly involves psychiatric counseling and 12-step programs. It presumably would be the final clinical hurdle before the vaccine — more than a decade in the making — might be approved for treatment. But one expert warns against expecting too much.

“Addiction vaccines are a promising advance, but it’s unlikely any treatment in this field will work for everyone,” said Dr. David Gorelick, a senior investigator at the National Institute on Drug Abuse. “Still, if they prove successful, they will give those working in drug addiction an important option.”

Scientists testing vaccine for cocaine users

Nothing says drug addiction more than a needle and syringe. But that’s exactly what a team of U.S. researchers believes can help cocaine users kick their menacing habit.

Two Baylor College of Medicine scientists based in Houston have developed a cocaine vaccine that creates antibodies that bind to the drug and prevent it from travelling from the bloodstream to the brain.

Unable to penetrate the brain, the drug can produce no high.

If the vaccine makes it through regulatory hurdles, it would be the first medication approved to treat cocaine addiction.

“It certainly is a way of combining immunology that had not been used before,” Tom Kosten, a professor of psychiatry and neuroscience at Baylor, said in a telephone interview yesterday. “We had always thought of altering the brain as a way to prevent drug abuse. This way, the drug never gets into the brain to begin with.”

Drug addiction treatment has largely been psychiatric counselling and 12-step programs. Dr. Kosten said that won’t go away – any approved vaccine would be complementary to behavioural therapy.

“If it’s approved in the U.S., then getting approval in Canada won’t be that difficult,” he said, adding that, if all goes well, a cocaine vaccine could be available in the United States in four years.

About 50 pharmaceutical options have previously been explored for cocaine addiction.

Dr. Kosten, who has been assisted in his decade-long research by his spouse, Therese Kosten, also a psychologist and neuroscientist at Baylor, asked the U.S. Food and Drug Administration last month to allow a Phase 3 clinical trial to begin this spring, involving 300 patients at six U.S. sites. Other trials are expected in Spain and Italy.

“Because there are no treatments for cocaine addiction, it’s been one of their fast-tracked programs at the FDA,” Dr. Kosten said. He is also at work on vaccines for heroin, nicotine and methamphetamine.

Yesterday, Evan Wood, co-principal investigator of the supervised injection facility evaluation in Vancouver, called the cocaine vaccine “new and provocative.”

“From a societal perspective, cocaine is one of the drugs that continue to be overlooked as one of the big problem drugs in our society,” said Dr. Wood, a physician epidemiologist at the British Columbia Centre for Excellence in HIV/AIDS.

“Crack cocaine is what is driving many of the social problems and public order problems and crime problems, particularly in the Downtown Eastside [of Vancouver].”

Dr. Wood said the “explosive HIV outbreak” in Vancouver’s east side is largely attributed to heroin users switching to cocaine, which leads to “more frequent injections, more chaotic behaviour and more syringe sharing.”

Learning about the immune system is opening all sorts of “avenues and possibilities,” said Dr. Wood. “But whether this is a useful tool remains to be seen.”

Certainly, the science is intriguing.

Since cocaine molecules are so small, the immune system does not recognize them and cannot make antibodies to attack them.

To fix that problem, Dr. Kosten attached inactivated cocaine to the outside of inactivated cholera proteins.

The immune system made harmless antibodies to the combination, but also recognized the drug when it was ingested. The antibodies bound to the cocaine, preventing it from reaching the brain, where the addictive highs are generated.

In Canada, there are no hard figures on how many are currently addicted to cocaine. Studies such as the Canadian Addiction Survey, published in 2004, found that more than 14 per cent of males, and 10.6 per cent of the total population, reported having tried cocaine.

Gerald Sidel, director of Addington Addiction Treatment Centre in Montreal, said yesterday that everybody is looking for the “magic bullet” to treat addictions.

He compared using modified cocaine to treat cocaine addicts to allowing alcoholics to engage in controlled drinking.

“Certainly if there is a way of helping people, I am not adverse to that,” Mr. Sidel said in a telephone interview yesterday. “But don’t treat drug addicts with drugs.”

Posted in Drugs and Medications, New drugs, Research, Vaccines | No Comments »