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Past News Items - Sept 2015

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In the News

New Cell Type May Help Explain Why Some People Have Dangerous Food Allergies

PAX Pharmaceuticals Awarded Patent for Repurposing by the United States Patent Office

Low Dog Briefs Legislators on Need for Supplements

Non-Invasive Breast and Ovarian Cancer Screening Study Released

Pathway Genomics Launches First Liquid Biopsy Test To Detect Cancer-Associated Mutations In High-Risk Patients

Released: 09/23/15

New Cell Type May Help Explain Why Some People Have Dangerous Food Allergies

Researchers have discovered a new cell type that appears to drive life-threatening food allergies and may help explain why some people get severe allergic reactions and others do not.

Reporting their study data Sept. 22 in the journal Immunity, scientists at Cincinnati Children's Hospital Medical Center say their findings in mice should also provide insights into new therapeutic strategies and diagnostics for food allergies and anaphylactic shock triggered by the immune antibody IgE (immunoglobulin E).

The authors report discovery of what they call "IL-9-producing mucosal mast cells" or (MMC9 cells). The cells produce large amounts of an inflammatory immune protein called interlukin 9 (IL-9), which amplifies anaphylactic shock in response to ingested food. Prior to this study, the primary cellular source of IL-9 was unknown, according to the authors.  

"Our study suggests that although you need to have some level of IgE to trigger a food allergy response, you also have to produce MMC9 cells to get a severe response and anaphylaxis," says Yui-Hsi Wang, PhD, lead investigator and a researcher in the Division of Allergy and Immunology at Cincinnati Children's. "Without these cells you will not get severe food allergies."

Set off by certain foods like peanuts, shell fish and a host of others, IgE-associated food sensitivity prompts the immune systems of some children to surge out of control. Unless there is immediate medical intervention, this can trigger a molecular chain reaction in the intestines and other organs – leading to diarrhea, hypothermia, respiratory distress and shock.

About 40 percent of children have some IgE-associated food sensitivity, but only 8 percent of the 40 percent develop the severe food reactions that can lead to anaphylactic shock, according to Wang.

"Unfortunately the best medical intervention for these allergies remains avoiding the foods that cause them," he said. "We don't know why some patients develop such a strong response and why some don't. This is where we as basic scientists are coming in to see if we can use mouse models to learn this, because mice are very much like humans."

Wang and his colleagues suspect that some people are wired genetically to have higher or lower susceptibility to severe IgE-related allergic reactions. Still, it also remains unknown exactly how genetics contributes to these molecular chain reactions.

Just as people with food allergies have different degrees of susceptibility, so do mice. To account for this, the researchers conducted their study in several distinct strains of genetically bred mice. They gave the mice an egg white protein called ovalbumin to trigger allergic reactions and study biological reactions in the animals.

They observed that after allergic sensitization, some mouse strains generated large populations of MMC9 cells while other strains did not. Mice that did not produce MMC9 cells exhibited only minor allergic responses. Mice that produced intestinal MMC9 cells all had severe allergic reactions, regardless of whether they had low or high levels of IgE.

Wang and his colleagues report that production of MMC9 cells required the presence of type-2 CD4+ T helper immune cells and the proteins interlukin-4 and STAT6. By producing significant amounts of IL-9, the MMC9 cells caused mastocytosis and the production of mast cells, which may migrate out of the intestines to other organs as they secrete histamines and other molecules that cause anaphylaxis.

To verify that MMC9 cells were fueling severe allergic reactions in the mice, the researchers treated the mice with an antibody, which eliminated the cells and decreased food allergy symptoms. When MMC9 cells were transferred back into the same mice, the animals resumed exhibiting food allergy symptoms.

Researchers next conducted tests to see if their identification of MMC9 cells was relevant to the development of human food allergies. Analyzing small intestine biopsy samples from food allergy patients (who gave authorized consent) the scientists looked for molecular signatures of MMC9 cells. They found significantly increased expression of the Il9 genetic transcript and other related transcripts in the samples of food allergy patients, suggesting a possible connection.

Wang said the researchers are now trying to find the human equivalent (orthologue) of the MMC9 cells they found in their mouse models. One goal the researchers have is to identify that cell and its biological mediators to see if it possible to develop a biomarker that might allow development of a blood test for food allergies. Eventually, Wang said, the team wants to develop a blood test that would allow clinicians to determine which patients are at higher risk for severe food allergies, and to find improved treatments for food allergy.

Also working with Wang on the study were co-first authors and Cincinnati Children's colleagues Chun-Yu Chen, PhD and Jee-Boong Lee, PhD the Division of Allergy and Immunology.


Funding support for the study came from, the National Institutes of Health (AI090129-1, A1073553), the Digestive Health Center Pilot and Feasibility Award (P30 DK078392), the Campaign Urging Research for Eosinophilic Diseases (CURED) Foundation, the Buckeye Foundation, and the Food Allergy Research Education Fund. 

Released: 09/22/15

PAX Pharmaceuticals Awarded Patent for Repurposing by the United States Patent Office

K-PAX Pharmaceuticals, a pioneer in immune function and energy metabolism medicines, today announced that the United States Patent and Trademark Office (US PTO) has issued an U.S. Patent for a repurposed version of methylphenidate (No.13/530,673) to the company. The patent is directed to compositions and methods for the treatment of Chronic Fatigue Syndrome (CFS) and other medical conditions associated with fatigue when methylphenidate is combined with a key combination of micronutrients (KPAX002).

“Our team at K-PAX Pharmaceuticals is very excited that the US PTO has granted patent protection to a breakthrough therapy with the potential to meet this critical unmet need”

K-PAX Pharmaceuticals, a privately-held biotechnology company is developing a repurposed version of methylphenidate (KPAX002), to improve its safety and efficacy for a variety of new indications, including CFS, by combining it with a key combination of mitochondrial support nutrients. Methylphenidate has a long history in medical care, is marketed as brand name Ritalin by Novartis International AG for the treatment of Attention Deficit Disorder, and is also currently available in a generic version - methylphenidate hydrochloride.

“Our team at K-PAX Pharmaceuticals is very excited that the US PTO has granted patent protection to a breakthrough therapy with the potential to meet this critical unmet need,” said Dr. Jon Kaiser, the Company’s Chief Executive Officer and Chief Medical Officer. “This newly issued patent provides the Company with broad claims to many possible uses for KPAX002. Our proprietary combination of key nutrients makes it possible to unlock the potential of a methylphenidate molecule that is well known and trusted by the medical community.”

A peer-reviewed paper on this treatment method was recently published in the International Journal of Clinical and Experimental Medicine (IJCEM)1. It details the theory behind how this new and improved version of methylphenidate, tested and refined for many years in clinical practice, demonstrates great potential by meeting defined clinical outcomes associated with the symptoms of CFS. This innovative treatment also has the potential to alleviate fatigue associated with other medical conditions such as fibromyalgia and autoimmune disorders.

In addition to the just published proof-of-concept trial, K-PAX Pharmaceuticals has also recently completed a Phase IIa double-blind, placebo-controlled trial, the findings of which also support KPAX002’s potential as a safe and effective treatment for CFS.

KPAX002 is an investigational mid-Phase II compound with positive Phase I and Phase IIa data demonstrating significant potential as a treatment for CFS. The U.S. Food and Drug Administration (FDA) has waived preclinical testing and the opportunity to obtain market exclusivity under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act is strong.

ABOUT Chronic Fatigue Syndrome (CFS)

The Centers for Disease Control (CDC) defines Chronic Fatigue Syndrome, or CFS, as a debilitating and complex disorder characterized by profound fatigue that is not improved by bed rest and which may be worsened by physical or mental activity. It is classified by the FDA as a “serious unmet medical need”. There are currently no approved treatments for this disease which afflicts an estimated 2.5 million people in the U.S. according to the CDC.

ABOUT K-PAX Pharmaceuticals

K-PAX Pharmaceuticals, based in Mill Valley, California, is a privately-held biotechnology company pioneering medicines to strengthen immune function and support optimal energy metabolism. Learn more at http://www.kpaxpharmaceuticals.com

Kaiser, JD. A prospective, proof-of-concept investigation of KPAX002 in chronic fatigue syndrome. Int J Clin Exp Med 2015;8(7):11064-11074.



K-PAX Pharmaceuticals, Inc.
Christy Maginn, 703-297-7194

Released: 09/13/15

Low Dog Briefs Legislators on Need for Supplements

Renowned physician and natural medicine proponent Tieraona Low Dog, M.D., briefs Congressional staff members about the value of dietary supplements.

Low Dog spoke September 9 at a briefing held by Congressional Dietary Supplement Caucus entitled, "Life Fortified: A Physician’s Case for Dietary Supplements,” referencing data from the Centers on Disease Control and Prevention (CDC) suggesting millions of Americans are deficient in numerous key nutrients. Such deficiencies include vitamin D (affecting 90 million Americans), vitamin B6 (affecting 30 million Americans), vitamin B12 (affecting 18 million Americans) and vitamin C (affecting nearly 16 million Americans.

“I’m extremely concerned when I hear misleading soundbites on the evening news that people don’t need vitamins because they get all the nutrients they need from their diet because it isn’t just patients who hear this, doctors also hear it repeatedly,” Dr. Low Dog said. “This mantra that Americans get all the nutrients they need from food is simply not true and the data demonstrates it is false. It is much harder than you think to get the nutrients you need from food alone.”

She also mentioned that low-income Americans (many of whom are affected by these and other deficiencies) can use Supplemental Nutrition Assistance Program benefits to buy junk food and soda, but not multivitamins.

The briefing was held in cooperation with the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.


Published on WholeFoods Magazine Online (9/11/15)

Released: 09/13/15

Non-Invasive Breast and Ovarian Cancer Screening Study Released

Breast and ovarian cancer can be well visualized with a radiation-free, non-invasive imaging tool according to a clinical trial announced today. The finding, released by a Stanford University Medical School physician at the International Contrast Ultrasound Society (ICUS) 30th Annual Conference in Chicago, found that molecular ultrasound microscopic bubbles bind to a receptor found in breast and ovarian lesions.

“This first in women clinical trial holds great promise in patients with breast and ovarian lesions”

"This first in women clinical trial holds great promise in patients with breast and ovarian lesions," said Dr. Juergen Willmann, Chief of Body Imaging and Professor of Radiology at the Stanford Medical School.

The clinical trial, performed in collaboration with collaborators at the UCSC in Rome and Bracco, focused on KDR (kinase insert domain receptor), a protein associated with certain diseases including cancer. 21 women with focal breast lesions and 24 women with ovarian lesions were injected with tiny gas microbubbles during an ultrasound exam. The study found that ultrasound allows visualization of KDR noninvasively with high sensitivity.

Dr. Willmann noted, "KDR expression on histology matched well with the presence of focal KDR-targeted ultrasound signal." Willmann added that this new molecular imaging technology, after further development and validation, could help diagnose cancer much better than regular current ultrasound technology in the future.

Released: 09/10/15

Pathway Genomics Launches First Liquid Biopsy Test To Detect Cancer-Associated Mutations In High-Risk Patients

Non-Invasive, Low-Cost Test Provides Early Detection—and Ongoing Monitoring of Previously Diagnosed Patients—Offering New Hope in the Fight Against Cancer

Pathway Genomics, a global precision medical diagnostics company, announced the launch of CancerIntercept™, its first liquid biopsy, a non-invasive screening test designed for early cancer detection and monitoring, for as low as $299. 

The test detects mutations that are commonly associated with lung, breast, ovarian, colorectal cancers and melanoma, as well as mutations that occur less frequently in other cancer types (such as pancreatic, head and neck, thyroid, gastric and prostate cancers).

The test is offered for two general populations: CancerIntercept™ Detect is the first liquid biopsy designed to detect tumor DNA in high-risk but otherwise healthy patients; CancerIntercept™ Monitor monitors patients with active or previously diagnosed cancer. Both programs use advanced DNA analysis to identify small DNA fragments that are shed from cancer cells and released into the bloodstream. The tests analyze the presence of 96 frequently occurring DNA mutations in nine cancer genes.

"Early detection is the single most important factor in ensuring successful treatments and improved survival rates," said Jim Plante, CEO and founder of Pathway Genomics. "Cancer patients and those at risk for the disease can take proactive steps to safeguard their health and fight back against some of the most virulent forms of the disease."

In addition, with CancerIntercept Monitor, physicians are able to supplement more invasive tissue biopsies and scans with liquid biopsies to monitor cancer treatment efficacy, disease progression and recurrence. CancerIntercept Monitor can also be ordered with personalized Clinical Trial Matching for later stage cancer patients.

"Rising levels of tumor DNA may indicate progression of the cancer before there is clinical or imaging evidence of tumor growth" said Dr. Glenn Braunstein, MD and Chief Medical Officer of Pathway Genomics. "Our liquid biopsy tests may also detect new mutations that occur over time and signal that the patient is becoming resistant to current therapy."

Testing can be initiated through the patient's treating physician or through Pathway's online physician referral network. For patients and physicians requesting repeat testing on a scheduled basis, a deeply discounted subscription service is available.

CancerIntercept Detect and CancerIntercept Monitor are offered through Pathway's integrated system, which streamlines the entire testing process from initial order to delivery of test reports. Key components of the system include physicians who will review online requisitions and order the tests; mobile phlebotomists to draw blood samples at the patient's home or office; and Pathway's medical oncology support team, who will discuss results with the patient's treating physician upon a positive result. All positive results are released via the patient's treating physician. Results are delivered approximately two to three weeks after testing.

About Pathway Genomics
Since its founding in 2008, Pathway Genomics has rapidly become a leader in the commercial healthcare industry. Pathway Genomics' success lies in its commitment to deliver innovative healthcare solutions. The company's program with IBM Watson is the first of its kind. The program is a smartphone app that merges artificial intelligence and deep learning with personal genetic information. The app provides users with personalized health and wellness information based on the individual's health history.




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