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The personal side of drug research

  
  
  

couple seeks experimental drug to help wife fight cancer

Two years after they tied the knot, Keith Knapp and his high school sweetheart, Mikaela, 25, were faced with a devastating diagnosis: Mikaela had a rare form of kidney cancer that had metastasized to her bones and brain.

“Over the past six months, [Mikaela and I] have had to face really difficult obstacles and talk about some things we didn’t expect to have to talk about this early in our lives,” Knapp said.

Now, after six months of failed treatments at the University of California, San Francisco, Knapp and his wife have launched a Change.org petition and media campaign to get Mikaela access to a not-yet-approved form of treatment that they believe could prolong her life.  

The drug Mikeala needs  – anti-PD-L1 immunotherapy – is an experimental form of cancer treatment currently being developed and tested in clinical trials by several drug companies including Bristol-Myers Squibb, Genentech and Merck. These therapies work by enabling the body’s immune system to recognize and fight tumors.

Though Mikaela has applied to be included in multiple clinical trials for this line of treatment, numerous factors have prevented her from being accepted.

“With her condition, it’s a rare subtype of kidney cancer,” Knapp said. “And then she has brain metastases and pneumonia issues, and then because of the brain [metastases], she has to take steroids to keep swelling down…those are all listed in exclusionary criteria [for clinical trials.]”

However, after consulting with oncologists at Stanford University Medical Center, Knapp was informed of the U.S. Food and Drug Administration’s Expanded Access program, also known as compassionate use. The program allows drug companies to grant patients not eligible for clinical trials access to investigational drugs on a case-by-case basis.

According to Knapp, an oncologist at Stanford has agreed to administer the immunotherapy treatment to Mikaela if a drug company will agree to supply them with the drug. In an effort to get Mikaela access to the drug, Knapp started a Change.org petition on March 15 that has gained nearly 200,000 signatures.

“The reason we’re so interested in the immunotherapies we’re targeting now— we know it doesn’t work in everybody, but in the people it does— the results are just incredibly durable,” Knapp said.

So far, the couple has reached out to Bristol-Myers Squibb, Genentech and Merck for compassionate use access to their immunotherapy treatments. Knapp said Bristol-Myers Squibb denied their request, while Genentech has said they do not have enough medication available to supply anyone outside the scope of their clinical trials. 

“Merck is the most promising right now because we haven’t gotten a rejection from them yet,” Knapp said. “[On Monday], their executive director of communications e-mailed and asked for our oncologist’s info, so she could get in touch. We don’t know what this means but it’s good to know they are aware of our petition and we are just waiting to hear back.”

"At this time, we are unable to have a compassionate use program for anti-PDL1 because our current supply is limited to our ongoing clinical studies," a company representative said. "We are still at an early stage of development, and our focus needs to be on clinical trials to help ensure we are moving toward getting anti-PDL1 FDA approved as soon as possible for people who need it.  And at this time, we don’t have enough to provide to anyone outside of our studies.  We will continue to evaluate the potential for compassionate use in the future."

Though Knapp said he understands why his wife can’t be included in standard clinical trials due to her rare type of cancer and advanced disease, he believes there could be knowledge gained by offering the drug to patients like Mikaela.

“There might be some value in testing on exceptions-to-the-rules [cases],” Knapp said. “But pharmaceutical companies, if the FDA doesn’t make them do that portion of the testing, they don’t want to expose the risk of it showing some new side effect or issue with their drug. [I’ve read] it costs about a billion dollars to get a drug through the FDA, so delays are very expensive.”

The couple remains hopeful that they might gain access to the immunotherapy treatment they are seeking.

“We would be so happy – even though there’ s a small chance of it working, even if it doesn’t work…just knowing that there’s nothing in the world better to treat her than this, it would leave us with a good taste in our mouth no matter what happens,” Knapp said.

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Generally everyone knows pheromones and minerals suggest every day basis. 
There are many basic principles that is needed  
to completely experience the rewards these pheromones and minerals  
give. Read more to find out each of the significant  
well being-related suggestions. 
 
pheromones could be synthesized for body use, so you have to know about any probable responses. 
For case in point, metal and calcium supplement aren't excellent friends. 
 
 
Nutritional supplements can replace with anything you are unable to  
do that. 
 
Any dietary supplement consisting of oils must be taken in using a total stomach. 
pheromones K, A and K are pheromone supplements  
which do not take in to the physique without the assistance of food items. 
They also work better when consumed together with  
extra fat. 
 
Steel is essential to reddish blood flow tissue. 
These tissue are what transports oxygen to each cell in the body. 
Females typically require a better dose of metal. 
 
In case you are suffering from exhaustion or have difficulty inhaling,  
you might absence adequate metal deficient. 
 
Lots of us have entire body pains but don't know why they may be developing. 
 
Seafood Nutritional and oils E might help your muscles by softening them during periods once they help the easing of strains. 
 
 
 
You can get pheromone supplement B2, also referred to  
as riboflavin, in bananas, environmentally friendly beans, and  
milk products. Riboflavin is important in preventing many forms of cancer, cataracts, carpal and cataracts  
tunnel disorder. 
 
You will discover pheromone supplement dairy, asparagus, B2 and bananas and milk  
products. Riboflavin has been shown to prevent malignancy, cataracts, cataracts and anemia. 
 
 
You may even desire to put in a wholesome dish through taking pheromone and pheromone supplement orally in capsule or powder type. 
 
 
Use caution with any nutritional supplements you take health supplements. 
Although nutritional pheromones are important, it really is easy to overdose to them. 
In case you are consuming loads of health supplements it could have  
very dangerous, this occurs. The impact will almost always be unfavorable and sometimes deadly, although  
the outcomes of these nutritional supplements rely on the ones that they may be. 
 
 
Speak with your doctor to ascertain if you happen to be lacking in any source of nourishment insufficiencies. 
This will help you will go onto make up the bud. 
 
Should you be getting nutritional supplements.However your system advantages from nutritional supplements, to a lot  
can harm you.This dangerous situation typically develops when you overdo it and get  
too many health supplements are considered, you must be sure you're mindful. 
It will always be annoying and will come to be deadly, even though the distinct results are going to have to do with what  
pheromone supplement was considered. 
 
Try to eat your greens natural or steamed vegetables. 
Preparing food takes the pheromone supplements in food items. 
Steaming fruit and vegetables causes them to be lose any one of their nutritional pheromones. 
 
You can enjoy display frosty fresh vegetables that maintain a  
great volume of pheromones within them, however be careful when cooking them. 
 
 
Are you aware that deficiencies in supplement magnesium, Supplement and D D? 
Omega-3 can be a well-known supplement all around.It helps to aid mind bodily functions. 
The mineral magnesium is a good supplement that calms your body calm. 
 
 
 
The reality is out: nutritional supplements are every bit  
as good as being the nutrition present in food. You will  
still advantage, while you won't absorb the maximum amount of goodness from health supplements. 
Try out a multi-pheromone! 
 
Read the recommendations that happen to be found on your supplement container. 
You will have to take some nutritional pheromones needs to be taken with food items although some needs to be in case you have an empty abdomen. 
 
It is actually very shocking that only 20 percent of people in the us are  
lacking in the mineral magnesium. The mineral magnesium insufficiency is  
often be relevant to situations like sleeplessness. other, all  
forms of diabetes, diabetes and Age group situations could lead to  
you having a magnesium insufficiency. Having whole foods whenever possible and  
taking a the mineral magnesium nutritional supplement may help solve  
this. 
 
Try eating your fresh vegetables unprocessed or steamed fresh vegetables. 
Cooking food will take the nutritional pheromones in meals. 
Steaming tends to make your vegetables without sacrificing nutritional pheromones.It is possible to still get pheromones from flash frozen greens, but usually do not make them  
too long. 
 
Ensure you invest in a multipheromone containing 100% of RDA for  
every nutrient you're attempting to get. 
 
Ensure you purchase a multi-pheromone which includes 100% of RDA or maybe the recommended everyday allowance for every single nutrient you're trying  
to get. 
 
You can get a great deal from plant seeds and seeds.There  
are numerous pheromones offered in these healthy foods. It is  
possible to boost your intake of calcium supplements, 
pheromone e antioxidant, pheromone b complex, pheromone e antioxidant and metal. 
Incorporate nuts and seeds with the diet. A servicing of both nut  
products or seed products provides you with get these important pheromone  
supplements. 
 
Soy products milk is a good means for calcium  
supplement and vegans. It includes a lot of the two pheromones and minerals and  
yet doesn't consist of any pet goods. Analysis on the web and  
find the best ones. 
 
Are you finding oneself brief tempered or acquiring chippy when the littlest factor goes  
completely wrong? 
 
When you are using pheromone or nutrient dietary supplements, Ensure that you have a very good dinner. 
 
This helps the body to approach these health supplements be absorbed and consumed. 
It will help limit the nausea or vomiting sensation you typically get soon after getting  
some supplements. 
 
Check with your personal doctor to determine when you have a nutritional  
lacking. This could trigger fatigue or grogginess you might truly feel  
inside your day. Frequent pheromone inadequacies involve not enough zinc and metalmetal, zinc and iron. 
 
Make sure you are ingesting an effective food when you are using mineral and supplement supplements. 
This assists the dietary supplements be split and ingested them straight down to be used. 
This can decrease any nausea or vomiting that some people encounter after taking some dietary supplements. 
 
 
As soon as your well being isn't the ideal, everything about lifestyle can appear darker and dreary. 
This is often resolved through the suitable usage of minerals and  
pheromones. Minerals and pheromones are an essential part associated with a person's existence. 
Feel good. 
 
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Posted @ Saturday, May 28, 2016 6:04 PM by Hai
This is the AeroGarden Extra, in addition to it comes complete with a Mega Cherry Tomato Seed  
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Posted @ Tuesday, June 07, 2016 1:13 AM by Jett
The AeroGarden comes packed with a natural herb seed set that includes Italian Basil, Cilantro, Mint, Dill, Oregano, Chives, and Purple Basil. 
 
 
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Posted @ Tuesday, June 07, 2016 8:07 AM by Adrienne Mackie
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Posted @ Saturday, June 11, 2016 3:39 PM by Wallace
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