Cure for Alzheimer'sDisease Coming Soon

As a member of the senior community and formerly involved in the development of new drugs, the following news just released by Associated Press excites me beyond imagination. If this news turns out positive, I feel the discovery of these three Alzheimer's drugs will be a historic event in drug development in the US. It will prolong the lives of millions of senior citizens all over the world. Here's the article for your reading pleasure.

Hopes for the Cure of Alzheimer's Coming Soon? By MARILYNN MARCHIONE(AP) We're about to find out if there will be a way anytime soon to slow the course of Alzheimer's disease. Results are due within a month or so from key studies of two drugs that aim to clear the sticky plaque gumming up patients' brains.

A pivotal study of a third drug will end later this year, and results from a small, early test of it will be reported next week at an Alzheimer's conference in Vancouver, British Columbia.

These three treatments are practically the "last men standing" in late-stage trials, after more than a decade of failed efforts to develop a drug to halt the mind-robbing disease. Current medicines such as Aricept and Namenda just temporarily ease symptoms. There is no known cure.

Experts say that if these fail, drug companies may pull out of the field in frustration, leaving little hope for the millions of people with the disease. An estimated 35 million people worldwide have dementia, which includes Alzheimer's. In the U.S., experts say about 5 million have Alzheimer's. The three treatments being tested are not even drugs in the traditional, chemical sense. They are antibodies — proteins made by the immune system that promote clearance of amyloid, the stuff that forms the plaque.

It's a strategy with a checkered history, and scientists aren't even sure that amyloid causes Alzheimer's or that removing it will do any good in people who already have symptoms. But there are some hopeful signs they may be on the right track. "Everybody in the field is probably holding their breath that there is something positive to come out of these trials," said Dr. Ronald Petersen, director of the Mayo Clinic's Alzheimer's Disease Research Center.

"It may not be a home run" in terms of improving memory and cognition, but if brain imaging or spinal fluid tests show the drugs are hitting their target, "they will be regarded as successes," he said. William Thies, scientific director of the Alzheimer's Association, agreed. Even if there is just a small effect, "that would be a huge finding because that would let you know you had a drug that worked," he said. It then could be tried as a preventive medicine or given earlier in the course of the disease when it may have more impact.

The three drugs and their developers are: _Bapineuzumab (bap-ih-NOOZ-uh-mab), by Pfizer Inc. and Johnson & Johnson's Janssen Alzheimer Immunotherapy unit. _Solanezumab (sol-ah-NAYZ-uh-mab), by Eli Lilly & Co. _Gammagard, by Baxter International Inc.

All are given as periodic intravenous infusions; some companies are trying to reformulate them so they could be given as shots. If a major study shows that one of the drugs works, there will be a huge effort to make it more convenient and practical, Thies predicted. Still, it would probably be very expensive.

The first two on the list are lab-made, single antibodies against amyloid. Gammagard is intravenous immune globulin, or IVIG — multiple, natural antibodies culled from blood. Half a dozen companies already sell IVIG to treat immune system and blood disorders. It takes 130 plasma donations to make enough to treat one patient for a year.

Treating Alzheimer's with IVIG would cost $2,000 to $5,000 every two weeks, depending on the patient's weight, said Dr. Norman Relkin, head of a memory disorders program at New York-Presbyterian Hospital/Weill Cornell Medical Center. He consults for some drugmakers and has patents for tests that measure amyloid.

Relkin is also leading a late-stage, 400-patient study of Gammagard that will wrap up late this year. A much smaller, earlier study he led showed less brain shrinkage among people receiving the drug than among those getting dummy infusions. "It was so startling that I sent it to two laboratories for independent verification," Relkin said.

Next week, at the Alzheimer's Association International Conference in Canada, Relkin will give a three-year progress report on 16 patients out of the original 24 enrolled in that earlier study.

Colon Cancer Chemotherapy Drugs

My son-in-law died last April after being diagnosed with stage IV colon cancer in 2010. Our family were all very devastated, since he was only 51 years old. Several chemotherapeutic regimens were tried by oncologists here in Northern California,in the most prestigious oncology treatment Research Center. The drugs tried did prolong his life for almost 2 years, but at the end, not one of the several experimental drugs saved his life, since he was already in stage IV when he was diagnosed. I had a feeling that my son-in-law could have survived the disease if he was diagnosed earlier, perhaps stage II or even III for the for therapy to be effective. My son-in-law left a 9-year old daughter and a 47-year old widow, because cancer sucks and kills if not diagnosed early. Please have a yearly physical check up even if you are feeling well.

This personal experience inspired me to do some web search on the drugs approved and what is in the pipeline for the treatment of colon cancer here in the US. The article is as follows:

Seven drugs are currently approved by FDA for colorectal cancer chemotherapy:

5-fluorouracil (5-FU, Adrucil), which is often given in combination with leucovorin

(Wellcovorin). Leucovorin is a vitamin that helps boost the effectiveness of 5-FU.

Capecitabine (Xeloda)

Oxaliplatin (Eloxatin)

Irinotecan (Camptosar)

Bevacizumab (Avastin)

Cetuximab (Erbitux)

Panitumumab (Vectibix)

Capecitabine is a pill form of 5-FU. The other drugs are administered intravenously. Many of these drugs are given in combination with each other. Common chemotherapy combination regimens include: 5-FU / LV (5-FU and leucovorin), FOLFOX (5-FU with leucovorin and oxaliplatin), FOLFORI (5-FU with leucovorin and irinotecan), IFL (Irinotecan, 5-FU, leucovorin), and XELOX (Capecitabine and oxaliplatin).

Side effects occur with all chemotherapeutic drugs. They are more severe with higher doses and increase over the course of treatment. Because cancer cells grow and divide rapidly, chemotherapy drugs work by killing fast-growing cells. This means that healthy cells that multiply quickly can also be affected. The fast-growing normal cells most likely to be affected are blood cells forming in the bone marrow, and cells in the digestive tract, reproductive system, and hair follicles. Nausea and vomiting is a very common side effect, but drugs such as ondansetron (Zofran) can help provide relief. In general, side effects are nearly always temporary, and medications can help manage them. Most patients are able to continue with normal activities for all but perhaps 1 - 2 days a month.

Specific Chemotherapy Drugs

5-Fluorouracil(5-FU) with Leucovorin. Adjuvant (following surgery) chemotherapy using 5-fluorouracil, either alone or with leucovorin (5-FU/LV), is the standard treatment for patients with high-risk colon cancer (Stage III or select patients with Stage II tumors). Leucovorin, also called folinic acid, is a form of the B vitamin folic acid, which helps increase 5-FU’s effectiveness. Patients are given a series of cycles that usually continue for at least 6 months.

There are many different ways of giving 5-FU, including intravenously over several hours once a week, intravenously daily for 5 consecutive days every month, or as continuous infusion with a portable pump. The most common side effects include nausea and vomiting, diarrhea, loss of appetite, hair loss, swelling of hands and feet, rashes, and mouth sores.

Studies indicate that bevacizumab administered intravenously along with IFL extends survival by about 5 months longer than IFL alone. Common side effects of bevacizumab include nosebleeds, fatigue, diarrhea, and high blood pressure. Less common side effects include stroke, heart attacks, angina, and formation of holes in the colon and stomach (gastrointestinal perforation).

Cetuximab. Cetuximab (Erbitux) was approved in 2004 for the treatment of metastatic colorectal cancer. This monoclonal antibody drug targets epidermal growth factor receptor (EGFR), a protein required by cancer cells in order to proliferate. It can be used either in combination with irinotecan or alone for patients who have not responded to irinotecan. Studies of the cetuximab-irinotecan combination suggest it can help in tumor shrinkage. It has a modest effect on survival, prolonging patients' lives by about an additional month or two. Recent guidelines recommend that cetuximab, and panitumumab (see below), should be given only to patients with tumors that express the wild-type KRAS gene. Patients with metastatic cancer should have tumors tested for KRAS gene status.

Panitumumab . Panitumumab (Vectibix) was approved in 2006 for treatment of colorectal cancer that has metastasized following standard chemotherapy. Like cetuximab, panitumumab is a monoclonal antibody drug that targets EGFR. In clinical trials, panitumumab helped delay disease progression and prolong survival by about 3 months. About 8% of patients experienced tumor shrinkage. Common side effects of this drug include skin rash, fatigue, abdominal pain, nausea, and diarrhea or constipation. Serious side effects include pulmonary fibrosis, severe skin rash, and skin reactions at the infusion site.

Investigational Biologic Drugs

One of the most promising recent developments in cancer treatment research has been the emergence of so-called "targeted therapies." Traditional chemotherapy drugs can be effective, but because they do not distinguish between healthy and cancerous cells their generalized toxicity can cause severe side effects. Targeted therapies work on a molecular level by blocking specific mechanisms associated with cancer cell growth and division.

Many targeted therapies are classified as biologic drugs. Bevacizumab (Avastin), cetixumab (Erbitux), and panitumumab (Vectibix) are currently the three biologic drugs approved for colorectal cancer treatment, but other drugs are in development. Targeted therapies involve many different types of drugs and molecular pathways. These include:

Angiogenesis Inhibitors: Anti-angiogenesis drugs inhibit the formation of new blood vessels that supply tumors with the blood, oxygen, and nutrients vital to tumor growth. Angiogenesis inhibitors, such as the monoclonal antibody bevacizumab (Avastin), target vascular endothelial growth factor (VEGF). Cediranib (Recentin), formerly AZD2171, is a new angiogenesis inhibitor that is in Phase III clinical trials for treatment of colorectal cancer.

Tumor Growth Factor Inhibitors: Tumor growth factors, such as epidermal growth factor, stimulate cell growth. Cetixumab (Erbitux) and panitumumab (Vectibix) are the two currently approved colorectal cancer drugs that target the epidermal growth factor receptor (EGFR). Nimotuzumab (TheraCIM) is currently being studied in combination with irinotecan.

Tyrosine Kinase Inhibitors. Tyrosine kinase is an enzyme associated with EGFR that is involved with the signaling mechanisms that prompt cell growth. The EGFR/tyrosine kinase inhibitor erlotinib (Tarceva), which is approved for the treatment of pancreatic and lung cancers, is being investigated as an adjuvant treatment for metastatic colorectal cancer. Sunitinib (Sutent), which is approved for renal cell carcinoma, is another tyrosine kinase inhibitor in trials for colorectal cancer.

Reference: New York Times, Health Section ( www.health.nytimes.com), July 12, 2012

FDA Approved Pre-Exposure Prophylaxis Pills for HIV

As a retired FDA chemistry team leader formerly involved in the development of new drugs, any news on new therapies about ant-infective and HIV drugs excite me to the fullest. I have a feeling though that patient's compliance to this new drug will be very, very low. As a new drug it will be expensive, so unless medical insurance covers at least 80% of the cost, Truvada will probably not be a best seller. The news on Truvada as a Pre-Exposure Prophylaxis (PREP) pills for HIV was published recently in USA Today as follows:

Truvada drug trials signal 'turning point' in AIDS epidemic By Liz Szabo, A trio of new studies highlights the promise and challenges of preventing the spread of HIV, the virus that causes AIDS: Giving anti-AIDS drugs to healthy but high-risk patients can dramatically reduce the risk of infection.

Two studies from Africa in heterosexual patients found that the drugs reduced the rate of HIV infection by 62% to 75%, a success rate that's comparable to results from studies of gay men, according to research in today's New England Journal of Medicine.

A third study in African women at high risk of infection, however, was ended early after researchers saw the drugs had no effect on HIV rates, largely because fewer than 40% of study participants took their pills as instructed. Overall, though, the results bolster the notion of giving anti-AIDS drugs to healthy but high-risk people before they're exposed to HIV, says Myron Cohen, a professor at the University of North Carolina-Chapel Hill and co-author of an accompanying editorial.

The strategy, known as PREP, or pre-exposure prophylaxis, is one of several powerful new tools in preventing HIV infection, he says. An advisory panel to the Food and Drug Administration in May recommended approving the drug used in the studies, sold commercially as Truvada, for prevention. Truvada, which combines the drugs tenofovir and emtricitabine, is already approved to treat the disease. In two of the studies, patients were randomly assigned to take either a placebo or Truvada.

In the third study, patients were randomly assigned to take either a placebo, Truvada or tenofovir. In that study, both tenofovir and Truvada worked about equally well. "We're at some sort of turning point in the AIDS epidemic," says Cohen, who will speak later this month at AIDS 2012, an international conference in Washington, D.C., focusing on science and policy. "It's not a single thing going on. It's the culmination of what's happened for 30 years. Each of them is moving the political world to start thinking about an AIDS-free generation." About 34 million people have HIV/AIDS, including 1.1 million in the USA, according to the Centers for Disease Control and Prevention. About 50,000 Americans are newly infected with HIV each year.

A key challenge to using these drugs will be finding ways to motivate patients to take them properly, Cohen says. Researchers should find out, for example, whether women stopped taking the pills because of side effects or simply underestimated their risk of getting HIV. In the study of African women, about 3% of women became infected with HIV during the study, whether they took placebos or active drugs. Using pills to prevent HIV is itself controversial.

On one hand, the pills could help protect the healthy partners of HIV-positive patients, says Anthony Fauci of the National Institutes of Health. The pills could give people a way to protect themselves, even when their partners refuse to use condoms, a common problem in some countries. But doctors have to be careful to test patients for HIV before prescribing Truvada. If someone already has HIV and doesn't take the pills faithfully, that person could develop and spread a resistant form of the AIDS virus, Cohen says.

Even AIDS activists are divided on the issue, says Guido Silvestri, a professor at the Emory University School of Medicine. Some argue that the pills should be given to everyone at risk of HIV, especially those with high-risk lifestyles. Others worry that the pills could give people a false sense of security and lead them to stop using condoms, which reduce the risk not only of AIDS but of other sexually transmitted infections and pregnancy, Silvestri says.

Figure Skating Gala, Winter Olympics, 2010

Figure Skating is one of my favorite winter sports. In 2010 the Winter Olympic games was held in Vancouver, Canada. At that time, my wife and I had been traveling, so we were not able to see most of the scheduled events in television. When I saw this video in You Tube the other day, I was so delighted, I have to share it with you.

The US won gold in the men's single ( Evan Lysacek), and silver in ice dancing. In the women's single, the US highest representative was ranked fourth and in the Pairs Event, the US highest pair was only in 10th place. But if you enjoy figure skating, this video is a must. It is good way to spend time indoors, to stay away from the over 100 degrees Fahrenheit temperature engulfing us now here in Northern California.



Event Men's singles Evan Lysacek (Gold) United States (USA) Evgeni Plushenko( Silver)Russia (RUS) Daisuke Takahashi ( Bronze)Japan (JPN)

Women's singles Kim Yu-Na (Gold) South Korea (KOR) Mao Asada( Silver)Japan (JPN) Joannie Rochette( Bronze) Canada (CAN)

Pairs Gold(China) Shen Xue Zhao Hongbo

Silver (China) Pang Qing Tong Jian

Bronze *Germany Aliona Savchenko Robin Szolkowy

Ice dancing: Canada (CAN)(Gold) Tessa Virtue Scott Moir

Meryl Davis (US) (Silver) Charlie White

Oksana Domnina (Russia)( Bronze) Maxim Shabalin

One of the most entertaining number was from the Russian Pairs representatives(4th place).

FDA Approves First Ever HIV Home Test

Last week, the FDA approved OraQuick, the first ever fully-private, over-the-counter HIV test. The test, which relies on a mouth swab and delivers results in 20-40 minutes, should be available in some 30,000 stores by October, according to an executive at OraSure, the company that manufactures OraQuick.

The widespread availability of such a test is obviously great news. The Times notes that the chances of an HIV-positive person spreading the disease is up to 96% lower if they're on anti-viral medication, and, according to the Center for Disease Control and Prevention, 20 percent of the 1.2 million Americans infected with HIV don't know they have it, with some 50,000 new infections occur each year. OraSure will also host a "24-hour question line, and advertise to high-risk groups, including gay men, blacks and Hispanics."

Dr. Anthony S. Fauci, the longtime AIDS researcher and director of the National Institute of Allergy and Infectious Diseases, called the new test a "positive step forward" and one that could help bring the 30-year-old epidemic under control.

Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first American blood test for the virus in 1984, called the F.D.A. approval "wonderful because it will get more people into care."

The test is not perfect. Due in some part to user error, it's 99.98% accurate when the user does not have HIV but only 92% accurate when it comes to positive tests. As the Times points out commenter Brinmat corrected, "only about one person in 5,000 would get a false negative positive test" while "about one person in 12 could get a false positive negative." The FDA noted that any positive test should be followed-up with a test at a doctor's office.

And, of course, there's some trifling bullshit about age restrictions. The FDA only approved use those 17 and older, so anyone youngish looking will probably have to show ID, which puts a damper on some of the privacy benefits and might scare off teenagers. Still, though, OraQuick is major progress.