Past News Items - April 2015

Cancer Treatment Centers of America (CTCA) at Western Regional Medical Center (Western) in Goodyear, Arizona has begun the Phase II portion of the first of six arms of this first-of-its-kind clinical trial, using a new immunotherapy treatment for patients with advanced small cell lung cancer, pancreatic cancer, and connective-tissue cancers, including breast cancer.

This innovative “PembroPlus” clinical trial combines an immunotherapy drug (pembrolizumab) with already FDA-approved chemotherapy drugs (gemcitabine, docetaxel, nab-paclitaxel, vinorelbine, irinotecan, and/or liposomal doxorubicin). The addition of pembrolizumab is aimed at activating the body’s own immune system to improve the results that otherwise might be achieved from chemotherapy alone. This combination of chemotherapy drugs is investigational in this study.

A patient with advanced-stage triple negative breast cancer received the first Phase II treatment on April 23. Triple negative breast cancer is one of the most aggressive and difficult to treat of all breast cancers.

The term triple negative refers to the fact that this type of cancer tests negative for estrogen receptors, progesterone receptors, and the HER2 protein, and therefore does not respond to hormonal therapy or therapies that target HER2 receptors. Studies have shown that triple negative breast cancer is more likely to spread beyond the breast and more likely to recur after initial treatment.

The study will enroll up to 140 patients who have exhausted previous standard-of-care treatments and are now eligible for clinical trial studies. It includes patients with advanced small cell lung cancer, pancreatic cancer, breast cancer, and a variety of sarcomas, which are cancers of the body’s connective tissues, including muscles, fat, nerves, and bones.

For more information or to enroll in the PembroPlus clinical trial, or other CTCA trials, email [email protected] or call 888-841-9129.

In Phase I of this study, initiated in January 2015, pembrolizumab with gemcitabine was successfully administered to a small group of patients to evaluate its safety, determine safe dosage, and identify any side effects.

Phase II of the study now enables CTCA researchers to administer this combination to a larger group of patients with triple negative breast cancer to see if it is effective and to further evaluate its safety.

“Patients in this study have advanced-stage cancers that are difficult to treat,” said Dr. Vivek Khemka, a medical oncologist at CTCA at Western and PembroPlus principal investigator. “We are investigating whether adding a drug that will stimulate the patients’ own immune systems to the conventional chemotherapy drugs that are used in their type of cancer could be a more powerful approach against their disease.”

Recent data reported in the New England Journal of Medicine and Lancet demonstrate promising results with antibody-based immunostimulatory therapy in treating melanoma, renal cell carcinoma, and non-small-cell lung cancer. Data have also shown synergetic effects of using cytotoxic chemotherapy in combination with immunostimulatory therapy. PembroPlus will build upon this data, extending treatment options to additional cancer types.

“We are using this combination therapy on cancer types not being targeted elsewhere, providing new treatment options for CTCA patients fighting advanced-stage cancers,” said Dr. Glen Weiss, director of clinical research and medical oncologist at CTCA at Western. “We hope that we can improve on results

Source: Cancer Treatment Centers of America, cancercenter.com

Released: 04/24/15

Missing Genetic Link Found in a Challenging Immune Disease

In the largest genetic study to date of a challenging immunodeficiency disorder, scientists have identified a gene that may be a "missing link" between overactive and underactive immune activity. The gene candidate also plays a key role in autoimmune diseases such as type 1 diabetes, rheumatoid arthritis, and allergies.

The researchers analyzed common variable immunodeficiency disorder (CVID), in which weak antibody responses lead to recurrent and often severe bacterial respiratory tract infections.

"Although this finding does not lead to immediate clinical applications, it raises new opportunities for understanding underlying causes of different immune disorders, and eventually developing more effective diagnostic tests and therapies," said co-study leader, Hakon Hakonarson, MD, PhD, director of the Center for Applied Genomics at The Children's Hospital of Philadelphia (CHOP).

Hakonarson is the corresponding author of the study published online April 20 in Nature Communications. His co-study leaders were Lennart Hammarstrom of Karolinska Hospital, Stockholm; Eva Ellinghaus of Christian-Albrechts-University in Kiel, Germany; and Tom Hemming Karlsen of Oslo University Hospital,Norway.

CVID occurs in roughly 1 in 25,000 individuals, both children and adults, in European populations. Defective B cells in the immune system cause a low level of antibodies, leaving patients vulnerable to recurrent infections. Some infections may cause permanent lung damage.

At least 25 percent of patients with CVID have various autoimmune disorders, in which the body mounts overactive immune responses. These include rheumatoid arthritis, stomach and bowel disorders, and autoimmune thrombocytopenia, a bleeding disorder. B-cell defects may also raise the risk of a type of lymphoma. Thus many CVID patients may develop symptoms resulting from an admixture of both insufficient and overactive immune components of immune dysfunction.

In the current study, the scientists searched for genetic differences between 778 patients with CVID and 11,000 control patients, all from the US, the UK, Germany, Sweden, and Norway. They used the Immunochip, a genotyping tool customized to detect hundreds of thousands of single-nucleotide polymorphisms (SNPs) already associated with 12 immune-related diseases.

Hakonarson and CHOP colleagues had discovered in 2011 that CVID was linked to the HLA-related gene region on chromosome 6p21; the current study confirmed that association. That gene region codes for the HLA (human leukocyte antigen) complex, a well-known group of proteins that helps recognize invading microorganisms.

In this current study, the investigators additionally found a robust, novel candidate for a risk gene in CVID: the CLEC16A gene region on chromosome 16p13.13. "This is the first risk susceptibility gene for CVID identified by a genome-wide association study that does not code for the HLA complex," said Hakonarson.

He added that the CLEC16A gene region offers a very compelling target for understanding CVID. In the current study, the international research team showed that mice with reduced activity in the corresponding animal gene had lower levels of B cells, the immune cells that are depleted in the human disease. In addition, previous genetic studies by Hakonarson and other researchers found that changes in CLEC16A raised the risk of type 1 diabetes, inflammatory bowel disease and other autoimmune disorders.

"The biological mechanisms that cause disease symptoms in CVID are still unclear," added Hakonarson, "but this study may suggest that altered function in CLEC16A and its associated proteins may represent a 'missing link' between immunodeficiency and autoimmunity in CVID. This may offer new opportunities for eventually designing more effective treatments."

Funds from the National Institutes of Health (grant HG006830, DK085708), the European Union, the Kubert Estate Foundation, and the Institute Development Fund of The Children's Hospital of Philadelphia supported this research. In addition to his CHOP position, Hakonarson is on the faculty of the Perelman School of Medicine at the University of Pennsylvania.

Jin Li et al, "Association of CLEC16A with common variable immunodeficiency disorder and role in murine B cells," Nature Communications, published online April 20, 2015. doi.org/10.1038/ncomms7804

Source: The Children's Hospital of Philadelphia, chop.edu

Released: 04/23/15

Modified Citrus Pectin Enhances Radiation Therapy in Prostate Cancer Treatment

Scientists at Tel Aviv Medical Center, Israel, have found that oral modified citrus pectin (MCP) enhances the anti-cancer and anti-metastatic effects of radiation therapy in the treatment of androgen-independent (AI) aggressive prostate cancer cells. Results were presented today at the American Association for Cancer Research (AACR) Annual Meeting 2015.

The study, titled, "Combined effect of modified citrus pectin (MCP) and ionizing radiation on viability and metastatic activity of prostate cancer cells," demonstrated that MCP enhanced radiation treatment of prostate cancer by increasing radio-sensitivity of aggressive prostate cancer cells. Previous research demonstrated MCP's anti-cancer actions, including induction of apoptosis, inhibition of proliferation and metastasis, and synergy with chemotherapeutic drugs and botanical compounds. MCP also protects against inflammation and fibrosis, via its binding affinity for the pro-inflammatory protein, galectin-3. However, this is the first study to clearly demonstrate MCP's ability to radio-sensitize aggressive, AI prostate cancer cells.

"Radio-resistance is a key contributor to the decreasing effectiveness of radiation treatment for aggressive, androgen-independent prostate cancer. The potential of MCP to increase radio-sensitivity in aggressive prostate cancer is encouraging news for researchers and patients alike," states Dr. Isaac Eliaz, MD, MS, LAc, one of the study's lead investigators. "Furthermore, MCP's ability to protect against inflammation and fibrosis via galectin-3 inhibition helps to minimize fibrotic damage to healthy tissues – a common side effect of radiation treatment."

In the study, researchers used cellular viability and clonogenic assays to evaluate the effects of MCP on the viability of AI-prostate cancer cell lines DU-145, PC-3, and CI-1, alone and in combination with radiation treatment. Alone, MCP induced a dose-dependent decrease in cell viability. The combination of MCP and radiation treatment produced synergistic effects against prostate cancer cell lines DU-145 and CI-1, and additive effects against cell line PC-3. Treatment of cells with MCP reduced cell migration by 20% and reduced cell invasion by 40%. These results demonstrate MCP to be an effective radio-sensitizer of AI prostate cancer cells, suggesting that MCP may be used to selectively enhance cytotoxicity and overcome radio-resistance.

The MCP used in the study is made from the pith of citrus fruit peels, and modified to a specific molecular weight and structure using a proprietary enzymatic and pH process. Previous research has demonstrated MCP's benefits in a number of cancer types, including breast, prostate, colon and others. MCP is also an effective chelator of toxic metals, as well as a selective immune enhancer shown to activate and increase cytotoxicity of NK cells ex vivo.

Released: 04/23/15

BCM-95 Curcumin and BosPure Boswellia in Prevention and Treatment of Colorectal Cancer

In the first study of its kind, researchers have demonstrated novel and previously unknown mechanisms of action by which BCM-95 Curcumin and BosPure Boswellia work synergistically to prevent colorectal cancer, and to demonstrate anti-tumor activity both in vitro and in vivo. [Toden S, Okugawa Y, Buhrmann C, Nattamai D, Anguiano E, Baldwin N, Shakibaei M, Boland CR, Goel A. Novel evidence for curcumin and boswellic acid induced chemoprevention through regulation of miR-34a and miR-27a in colorectal cancer. Cancer Prev Res (Phila). 2015 Feb 23. PubMed PMID: 25712055.]

"We have known for a while that curcumin and boswellia both have potent anti-cancer properties. In this study, we investigated how they work in conjunction to reduce proliferation and increase cell cycle arrest and apoptosis (various mechanisms by which cancer cells are killed). We found that the two together activate a broader array of gene regulators called microRNAs, with a wider spectrum of impact compared to either compound individually," says Ajay Goel, Ph.D., Director of Epigenetics, Cancer Prevention, and Cancer Genomics, Baylor Research Institute, Baylor University Medical Center, Dallas, TX, one of the study's authors.

"In an animal model of colorectal cancer, we saw that the botanicals influenced tumor growth by the 2^nd or 3^rd day of administration, which is very promising," says Dr. Goel.

"Also, about 50 percent of people with colon cancer have a mutation in the p53 gene. Cancer drugs that target the p53 gene do not work for these individuals. We examined p53 activity and found in an animal model that even if there is a mutation in this gene, by adding curcumin and boswellia, it became responsive to chemotherapy treatment. More human research is needed, but this could be an incredibly important finding for helping people with this mutation," Dr. Goel concluded.

It is important to note that the form of curcumin used in the study, BCM-95 Curcumin, has unique specifications, including high absorption and inclusion of turmeric essential oil, and BosPure Boswellia is standardized for more than 10% AKBA and is purified to remove most of the proinflammatory compounds. Therefore, results may not apply to other forms of curcumin and boswellia.

Ajay Goel, Ph.D., is Director of Epigenetics, Cancer Prevention, and Genomics at Baylor University Medical Center

Released: 04/23/15

ACE Study Focuses on Safety of Bikram Yoga by Measuring Heart Rate and Core Temperatures During Class

In a new independent study commissioned by the American Council on Exercise (ACE), researchers found that a large number of the participants reached a very high core temperature of greater than 103 degrees F during a Bikram yoga class. Notably, well-established sports medicine guidelines state that exertion-related heat illnesses can occur at a core temperature of 104 degrees F.

A typical Bikram yoga session lasts 90 minutes and consists of 26 poses and two breathing exercises performed in a room heated to 105 degrees F with 40 percent humidity. Many Bikram yoga practitioners say that having the mental strength and focus to overcome this challenge is a big part of the draw. Many advocates of Bikram claim improved mindfulness, flexibility, strength, muscle tone, and general fitness as a direct result of the practice.

But, according to ACE, though there are several benefits to practicing Bikram yoga, the concerns associated with the potential for heat-related challenges among some participants appear warranted.

ACE Chief Science Officer Cedric X. Bryant, Ph.D., FACSM, noted, “Exercising in hot and humid environments—whether inside a studio while practicing Bikram yoga or running outside during the warm months of summer—can place participants at risk for heat-related illness, especially if individuals do not adequately hydrate before, during, and after exercise.” Bryant added, “It’s essential that instructors of Bikram yoga are educated on how to recognize the signs of heat intolerance and respond appropriately in the event that a heat-related illness occurs.”

Conducted by researchers at the department of exercise and sport science in the University of Wisconsin, La Crosse, the study tested 20 (7 male and 13 female) apparently healthy volunteers ranging in age from 28 to 67. All subjects regularly practiced Bikram yoga. Each participant swallowed a core body temperature sensor and wore a heart-rate monitor throughout a class led by a certified instructor. Core temperature was recorded prior to the start and every 10 minutes during the session. Researchers also recorded heart rate every minute during the class, and ratings of perceived exertion at the end of class using a 1 to 10 scale.

Results showed the average heart rate for men was 80 percent of the predicted maximum and 72 percent for women. The highest heart rate achieved during the class for men was 92 percent of the predicted maximum, while 85 percent for women. The average highest core temperature was 103.2 degrees F for men and 102.0 degrees F for women. One male in the study had a core temperature of 104.1 degrees F by the end of the 90-minute class, and seven of the 20 subjects had core temperatures greater than 103 degrees F. While none of the subjects in the study exhibited signs or symptoms of heat intolerance, core temperatures such as these can pose a certain level of risk for some participants.

“Given the popularity of Bikram yoga and its proven benefits, it is likely here to stay,” Bryant said. “It’s up to the instructors to make sure it is done safely and efficiently by adapting participants gradually to the hot and humid environment, and encourage them to drink fluids before, throughout, and after the class.”

Released: 04/22/15

Protein Identified That Serves as a "Brake" on Inflammation

Researchers have identified a protein that offers a new focus for developing targeted therapies to tame the severe inflammation associated with multiple sclerosis (MS), colitis and other autoimmune disorders. St. Jude Children's Research Hospital scientists led the study which appears today in the scientific journal Immunity.

Investigators showed that the protein NLRP12 works in T cells to limit production of chemical messengers or cytokines that fuel inflammation. T cells are specialized white blood cells produced to eliminate specific infectious agents and other threats. Deletion of the Nlrp12 gene led to increased cytokine production in T cells. Specially bred mice that received T cells deficient in the protein NLRP12 developed more severe symptoms of colitis and the chronic skin condition atopic dermatitis.

The results suggest how mutations in the Nlrp12 gene cause disease, which until now was unclear. "We have identified a possible mechanism of how mutations in Nlrp12 lead to atopic dermatitis and possibly other diseases in humans," said corresponding author Thirumala-Devi Kanneganti, PhD, a member of the St. Jude Department of Immunology. "Understanding the precise inner-workings of NLRP12 in T cells will help guide efforts to develop therapies to ease symptoms by taming inflammation driven by T cells."

Researchers also found that NLRP12-deficient mice may offer a much needed mouse model for studying the development of balance and movement problems in people with multiple sclerosis (MS).

NLRP12 belongs to a family of proteins best known for working in the innate immune system to help cells sense threats and then launch the inflammatory response to eliminate them. The innate immune system is the body's first line of defense. It works with T cells and other components of the adaptive immune system to safeguard health.

Previous research from Kanneganti's laboratory showed that rather than fueling production of the cytokines that drive inflammation, NLRP12 played a different role in the innate immune response. Researchers showed that in the innate immune system, NLRP12 worked in the NF-kB signaling pathway to restrain inflammation.

The latest study showed that NLRP12 serves the same anti-inflammatory function in T cells. Investigators demonstrated that NLRP12 works through the NF-kB pathway in T cells to regulate production of interleukin 4 (IL-4) and other cytokines.

"This study provides the first evidence that NLRP12 can function in adaptive immune cells to regulate inflammation and impact various autoimmune disorders," Kanneganti said. "That's important because excessive inflammation plays a role in many human diseases, including cancer."

The findings could also advance efforts to understand and treat MS, a chronic inflammatory disorder in which T cells attack and damage the myelin sheath that insulates nerve fibers. The resulting demyelination disrupts nervous system functioning, causing MS symptoms.

Demyelination and inflammation both occur in the current mouse model of MS and result in progressive paralysis beginning in the tail. Surprisingly, the deletion of Nlrp12 in mice led to different symptoms. The mice had less paralysis, but developed problems with balance and movement, just like MS patients. Investigators linked the new symptoms to increased IL-4 production by T cells that lacked NLRP12. When excess IL-4 was eliminated using various methods, the mice again exhibited classical paralysis rather than the other symptoms related to balance and movement.

The study's first author is John Lukens, PhD, formerly of St. Jude and now of the University of Virginia. The second author is Prajwal Gurung, Ph.D., a St. Jude postdoctoral fellow who contributed significantly to the study. The other authors are Patrick Shaw, Maggie Barr, Scott Brown, Peter Vogel and Hongbo Chi, all of St. Jude; and Md. Hasan Zaki, formerly of St. Jude and now of the University of Texas Southern Medical School, Dallas.

The study was funded in part by grants (AR056296, CA163507, AI101935) from the National Institutes of Health and ALSAC.

Released: 04/22/15

New Study Shows Cleveland HeartLab Inflammation Testing can Prevent Thousands of Heart Attacks and Strokes, Averting $187 Million in Healthcare Costs for Cardiovascular Disease -- The Number One Killer of Men and Women in the US

Cleveland HeartLab Inc. (CHL), the premier cardiovascular disease management company, and MDVIP, the leader in personalized, preventive medicine, are pleased to announce the publication of a seminal peer review study in the Journal of Medical Economics. The study shows that by improving cardiovascular disease risk (CVD) assessment, CHL's inflammation testing could reduce heart attacks and strokes by nearly 10 percent.

The risk assessment, treatment and economic model—published by the Journal of Medical Economics and based on the risk reduction achieved among patients enrolled in the MDVIP wellness program—showed that for a typical population of 1 million Americans, the addition of CHL's inflammation testing could reduce the average heart attack and stroke rate by approximately 10 percent. In this study, this reduction results in $187.7 million in cost savings over five years, or $3.13 per member per month (PMPM) for the typical US commercial payer compared to current standard of care. This savings could dramatically impact the system as approximately 15 percent ($450 billion per the Centers for Disease Control and Prevention) of the $3.8 trillion spent on healthcare in the U.S. went to treating heart attacks and strokes.

"This study shows that by more accurately measuring CVD risk with tools that detect arterial inflammation, we can decrease the overall number of heart attacks and strokes, allowing clinicians and health plans to deploy resources more strategically in order to better manage patient outcomes and costs," said Marc Penn, MD, PhD, FACC, Director of Research at Summa Cardiovascular Institute and Chief Medical Officer of CHL. "Even small reductions in heart attacks and strokes lead to enormous cost savings because these events are so traumatic and so costly to treat. Furthermore, we're at a major crossroads in our focus on cholesterol testing to predict heart attack and stroke. As clinicians and researchers eagerly seek ways to improve the efficacy of cholesterol lowering in cardiovascular disease, there is still a great need to better assess near-term CVD risk in order to determine which patients need therapy and which patients on therapy still have excessive risk."

The publication titled: The Economic Impact of Implementing Multiple Inflammatory Biomarker-Based Approach to Identify, Treat and Reduce Cardiovascular Risk looked at the impact of inflammation testing, in addition to cholesterol testing, on the health outcomes of a typical U.S. health plan with one million members. Patients with evidence of decreased levels of inflammatory markers for CVD—as measured with tests offered by CHL—have consistently been shown to have better outcomes.

"MDVIP physicians routinely use CHL's inflammation testing and, as a result, are identifying more patients at risk in clinical practice," said Andrea Klemes, DO, FACE, Chief Medical Officer, MDVIP. "It's rewarding to see the results that our physician network achieves through the MDVIP model by decreasing inflammation and clinical events. It's also exciting to think about the impact of these results extrapolated to a larger population. Inflammation has been proven to identify hidden risk in real-world clinical practice giving us a more complete picture of risk beyond our current arsenal of diagnostic tools."

An important and novel component of this study is the inclusion of real world data used as model inputs for the effects of a multi-marker approach to create a tiered patient risk profile and the treatment success of lowering inflammatory markers. Specifically, the measurement of Myeloperoxidase (MPO), Lp-Pla2 and hsCRP were used to generate tiered risk. These data were extrapolated onto a patient population of 1 million by a team of biostatisticians, healthcare economists and clinicians. The research model strongly suggests that by implementing routine testing with CHL inflammation testing and a multi-tiered approach to cardiovascular risk, a decrease in non-fatal MI events and non-fatal IS events can be achieved.

"While I served as Secretary of Health and Human Services a decade ago, it was already clear that the way we managed CVD in the U.S. was financially unsustainable—a reality that has only worsened," said Tommy Thompson, former US HHS Secretary and a member of CHL's Board of Directors. "By controlling the costs of CVD with these advanced tests, we can materially control the cost of the healthcare system because CVD patients—a relatively small number of patients as compared to the entire population—are the most costly to treat."

Routine inflammation testing helps identify individuals with previously unidentified risk so that steps can be taken to decrease vascular inflammation, improve their state of wellness and lower their risk of a heart attack and death. This study demonstrated a significant savings in healthcare spending for 1 million patients. Applied nationally, the true savings is likely much greater. According to the Centers for Disease Control and Prevention, over 100 million Americans have at least one major risk factor for heart attack and stroke.

The study was conducted in collaboration with MDVIP and a team of expert economists from the Analysis Group, a leading health economics consultancy. Data from MDVIP and CHL supported the economic analysis using real-world data from over 100,000 patients who were monitored and managed using CHL's inflammation testing.

Released: 04/17/15

Burzynski Research Institute, Inc. Announces Publication of Phase II Results in Patients with Non-Diffuse Intrinsic Pontine Glioma

Burzynski Research Institute, Inc., a biopharmaceutical company dedicated to the development and commercialization of novel therapies for patients with brain and brainstem tumors and other cancers, announces the publication of data by the Burzynski Clinic on two of the company’s clinical stage products Antineoplaston A10 injections (Atengenal) and Antineoplaston AS2-1 injections (Astugenal). Antineoplastons A10 and AS2-1 are synthetic amino acid derivatives.

A phase two, single-arm, two-stage, interventional trial was conducted in thirty-nine patients with inoperable brainstem gliomas. A subgroup analysis in eleven patients that were diagnosed with non-diffuse intrinsic pontine glioma (NDIPG) is presented. Data describing the results of treatment of the subgroup of patients diagnosed with pediatric recurrent DIPG were previously published. Overall survival in NDIPG at 1, 5, 10, and 15 years are presented. One NDIPG patient experienced a serious, but reversible Grade 4 hypokalemia. Grade 1 and 2 adverse events, including hypernatremia and somnolence, were also reported and were consistent with those observed in other clinical trials.

The publication entitled, “A Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Brainstem Gliomas. The Report on Non-Diffuse Intrinsic Pontine Glioma (protocol BT-11),” was published in J Cancer Ther 2015; 6: 334-344. The manuscript also appears in the online version dx.doi.org/10.4236/jct.2015.64036.

Released: 04/17/15

Study Shows Pain Relief for Knee Osteoarthritis with Co-Administered Traumeel and Zeel Injections

A study of 232 patients was recently presented at the American College of Rheumatology 2014 Annual Meeting demonstrating that co-administered Traumeel (Tr14) and Zeel (Ze14) intra-articular (IA) injections are safe and effective treatments for moderate to severe pain associated with knee osteoarthritis (OA) vs. IA placebo. The data was discussed in a podium presentation by Carlos J. Lozada, MD, professor of clinical medicine and the University of Miami Miller School of Medicine.

In the multi-center, double-blind, randomized, controlled trial, patients with moderate-to-severe chronic knee OA were randomized to three weekly IA injections of either Tr14 and Ze14 or saline. The primary efficacy variable was change in knee pain from baseline to end-of-study (week 17) as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) OA pain subscale. Secondary measures included TOTAL WOMAC and subscores for stiffness and physical function, change in pain following a 50-foot walk, and patient and physician global assessments.

By day 15, patients experienced significant reductions in pain, and secondary endpoints were directionally consistent. Of note, the study does not report any related serious adverse events. Adverse events were generally mild and reported as unrelated to treatment.

"In this study of 232 patients, Traumeel and Zeel provided statistically significant and clinically relevant pain relief for patients with osteoarthritis of the knee, a condition for which pain relief can be challenging to achieve," said Dr. Lozada. "I look forward to further research on this treatment to confirm and build on the findings in the study. This potentially represents an additional option in the management of osteoarthritis, especially for those patients who cannot tolerate non-steroidal anti-inflammatory drugs (NSAIDs), are not candidates for corticosteroid treatment, or do not respond to other therapies."

Traumeel and Zeel injection solutions have been available globally for more than 60 years to help manage the pain of osteoarthritis. In the last 10 years, more than 1.5 million ampules of Traumeel and Zeel have been sold in the US.

"This study supports the clinical feedback we hear from healthcare professionals regarding positive outcomes with Traumeel and Zeel injections in knee osteoarthritis," said Jaclyn Chasse, ND, medical director at Emerson Ecologics. "We are proud to distribute prescription products like Traumeel and Zeel that are safe, effective, and backed by clinical evidence."

Emerson Ecologics is the leading provider of injectable Traumeel and Zeel to qualified healthcare practitioners throughout the United States.

Note: These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.

Source: Emerson Ecologics LLC, emersonecologics.com

Released: 04/16/15

Personal Genome Diagnostics Study Highlights Limitations of Tumor-Only Sequencing for Cancer

Personal Genome Diagnostics, Inc. (PGDx), a provider of advanced cancer genome analysis and testing services, today announced the publication of a landmark study showing that many of the genetic alterations identified using tumor-only sequencing are not actually associated with the cancer, but instead reflect inherited germline mutations already present in the normal cells of the individual. The study is in the April 15 edition of Science Translational Medicine¹ and was conducted by PGDx scientists working in collaboration with company co-founders Dr. Victor Velculescu and Dr. Luis Diaz, Jr. and their colleagues at Johns Hopkins University.

In the study, researchers from PGDx and the Johns Hopkins Kimmel Cancer Center compared DNA from tumors and from normal cells in 815 patients with a wide variety of cancers. They found that almost half of patients analyzed using tumor-only approaches had genetic alterations detected in their tumors that were also present in their normal cells, indicating that the alterations were 'false positive' changes not specific to the tumor. The growing use of personalized medicine is predicated on tailoring treatments to the genetic makeup of the patient's tumor, so the high rate of false positives uncovered in the study has implications for the accuracy of the approach when it relies on tumor-only sequencing.

Sian Jones, PhD, Vice President of Genome Sciences at PGDx and a co-author of the study, commented, "We knew from our pioneering whole exome analyses of cancer patients that a significant number of the genetic alterations that were thought to be associated with tumors were also present in the inherited germline DNA. By comparing tumor DNA to DNA from normal tissue, we were able to separate out those genetic alterations that are truly tumor-specific. Accurately identifying tumor-specific alterations is essential to realizing the potential of personalized medicine to achieve better treatment outcomes. As a result of this work, we decided to include the option to analyze both normal and tumor tissue DNA when we launched our CancerSelect^TM targeted gene panel, which is designed to detect those genetic alterations in the individual's cancer that are most relevant to optimizing treatment. The study published today with our colleagues at Johns Hopkins University is a powerful validation of that decision."

The researchers identified 382 genetic alterations in the study patients that were potentially tumor-specific by first detecting all of the genetic changes in their tumors and then eliminating those that were well-known germline alterations. However, when the remaining genetic alterations were compared to the genomic profiles of the patients' germline DNA, an average of 249, or 65%, turned out to be false positive changes that were already present in the normal cells.

The researchers also looked at the alterations in "actionable genes," which were defined as genes which have been identified as potential targets for cancer drugs or investigational cancer therapies. In the study, 48 percent, or almost half of the tumor samples, had at least one false positive mutation in an "actionable gene." These findings are noteworthy because use of false positive findings to guide personalized treatment decisions could result in a substantial number of patients receiving therapies that are not optimized for their cancer.

Antony Newton, Chief Commercial Officer at PGDx, noted, "PGDx is committed to leadership in bringing the latest advances in cancer genomics to the researchers, drug developers, healthcare providers and patients we serve. Our founders are pioneers in the field and their continuing involvement with the company allows us to rapidly incorporate new scientific knowledge into our internal R&D programs, which are charged with continuously refining and improving our approaches. We also are well-situated to contribute real world insights and resources to advancing the science of cancer genomics, as exemplified in the collaboration between PGDx and Johns Hopkins that produced this landmark study."

PGDx's CancerSelect Targeted Gene Panel analyzes FFPE samples to detect all major genetic alteration types with high sensitivity and specificity, covering nearly all of the actionable cancer genes currently associated with therapies that are FDA-approved or in actively-enrolling clinical trials. It offers the option to compare tumor DNA with normal DNA to differentiate cancer-specific mutations from the germline mutations already present at birth.

PGDx is the only company offering a complete range of cancer genome analysis tools, including exome and targeted approaches for tissue specimens, targeted approaches for plasma samples and a variety of custom tissue and plasma-based options designed to address the specific research needs of cancer researchers and drug developers.

1 - S. Jones, V. Anagnostou, K. Lytle, S. Parpart-Li, M. Nesselbush, D. R. Riley, M. Shukla, B. Chesnick, M. Kadan, E. Papp, K. G. Galens, D. Murphy, T. Zhang, L. Kann, M. Sausen, S. V. Angiuoli, L. A. Diaz Jr., V. E. Velculescu, Personalized genomic analyses for cancer mutation discovery and interpretation. Science Translational Medicine 7, 283ra53 (2015).

Released: 04/16/15

One World Cannabis Moves Forward to Test Human Cells in its Multiple Myeloma Study

OWC Pharmaceutical Research Corp. (OTCQB: OWCP), today announced that its wholly owned subsidiary, One World Cannabis Ltd. ("the Company"), an Israel-based developer of cannabinoid-based therapies targeting a variety of different indications, is proud to announce that after receiving preliminary results on the effect of several combinations of cannabinoil (CBD) and tetrahydrocannabidoil (THC) on multiple myeloma cells, its basic science study continues with multiple myeloma human cells.

Multiple Myeloma, a cancer of plasma cells, accounts for 10 percent of all hematologic malignancies. It is the second most common hematologic cancer and represents 1 percent of all cancer diagnoses and 2 percent of all cancer deaths.

The basic science phase of the study began several weeks ago, at Sheba Academic Medical Center Multiple Myeloma Research Lab. Dr. Merav Leiba, Head of Sheba's Multiple Myeloma Outpatient Clinic and Multiple Myeloma Research Lab is leading the study. The company conducts the study in accordance with Sheba's Internal Review Board (IRB) approval. Results of this stage of the study are expected within two months, according to the milestones set in the collaboration agreement with the Academic Medical Center.

"We are excited to see our vision materialized into a scientific study conducted at the leading academic medical center in Israel, and headed by one of the worldwide leaders in Multiple Myeloma research." said One World Cannabis COO Mr. Alon Sinai.

Released: 04/13/15

Breakthrough in Cancer Research

A new study by researchers at the Technion-Israel Institute of Technology could hold a key to control cancer cell growth and development. In a recently published paper in CELL, the team reports on the discovery of two cancer-suppressing proteins.

The research was conducted in the laboratory of distinguished professor Aaron Ciechanover, of the Technion Rappaport Faculty of Medicine. The team was led by research associate Dr. Yelena Kravtsova-Ivantsiv and included additional research students and colleagues, as well as physicians from the Rambam, Carmel, and Hadassah Medical Centers, who are studying tumors and their treatment.

KPC1, an important and vital pathway in the life of the cell, is responsible for the degradation of defective proteins that could damage the cell if not removed. The ubiquitin system tags these proteins and sends them for destruction in the cellular complex known as the proteasome. The system also removes functional and healthy proteins that are not needed anymore, thereby regulating the processes that these proteins control.

Usually, the proteins that reach the proteasome are completely broken down, but there are some exceptions, and the current line of research examined p105, a long precursor of a key regulator in the cell called NF-kB. It turns out that p105 can be broken down completely in certain cases following its tagging by ubiquitin, but in other cases it is only cut and shortened and becomes a protein called p50.

NF-kB has been identified as a link between inflammation and cancer. The hypothesis of the connection between inflammatory processes and cancer was first suggested in 1863 by German pathologist Rudolph Virchow, and has been confirmed over the years in a long series of studies. Ever since the discovery (nearly 30 years ago) of NF-kB, numerous articles have been published linking it to malignant transformation. It is involved in tumors of various organs (prostate, breast, lung, head and neck, large intestine, brain, etc.) in several parallel ways, including: inhibition of apoptosis (programmed cell death) normally eliminates transformed cells; acceleration of uncontrolled division of cancer cells; formation of new blood vessels (angiogenesis), which are vital to tumor growth; and increased resistance of cancerous cells to irradiation and chemotherapy.

As noted, the precursor p105 is "handled" by the ubiquitin system in one of two parallel and equally prevalent ways. It is either destroyed completely, or shortened and transformed to p50. The current research deciphers the decision-making mechanism that determines which process will be applied to the protein: When a ubiquitin system component called KPC1 is involved in the process and attaches ubiquitin to p105, the protein is shortened to become p50. When ubiquitination is mediated by another component of the system (and without KPC1), p105 is degraded.

The decision between these two options has significant implications on the cell, as the presence of high levels of KPC1 (which generates p50) and p50 (the product of the process)—with the accompanying disruption of the normal ratios between the processes—suppresses the malignant growth and apparently protects the healthy tissue. The current research was conducted on models of human tumors grown in mice, as well as on samples of human tumors, and a strong connection was discovered between the suppression of malignancy and the level of the two proteins, clearly indicating that the increased presence of KPC1 and/or p50 in the tissue can protect it from cancerous tumors.

Professor Ciechanover, who is also the president of the Israel Cancer Society, notes that many more years are required "to establish the research and gain a solid understanding of the mechanisms behind the suppression of the tumors. The development of a drug based on this discovery is a possibility, although not a certainty, and the road to such a drug is long and far from simple."

Professor Ciechanover won the Nobel Prize in chemistry in 2004 (jointly with Professors Avram Hershko—also from the Technion—and Irwin Rose, of the Fox Chase Cancer Center) for the discovery of the ubiquitin system. The current line of research is a continuation of that discovery.

The Technion-Israel Institute of Technology is a major source of the innovation and brainpower that drives the Israeli economy and a key to Israel's renown as the world's "Start-Up Nation." Its three Nobel Prize winners exemplify academic excellence. Technion people, ideas, and inventions make immeasurable contributions to the world including life-saving medicine, sustainable energy, computer science, water conservation, and nanotechnology. The Joan and Irwin Jacobs Technion-Cornell Institute is a vital component of Cornell NYC Tech, and a model for graduate applied science education that is expected to transform New York City's economy.

American Technion Society (ATS) donors provide critical support for the Technion—more than $2 billion since its inception in 1940. Based in New York City, the ATS and its network of chapters across the US provide funds for scholarships, fellowships, faculty recruitment and chairs, research, buildings, laboratories, classrooms and dormitories, and more.

Source: American Technion Society, ats.org

Released: 04/07/15

A New Test to Simultaneously Detect 22 Respiratory Pathogens

Luminex Corporation has announced the launch of the NxTAG Respiratory Pathogen Panel (RUO). The NxTAG Respiratory Pathogen Panel is the only respiratory assay that enables laboratories to both simultaneously detect 22 respiratory pathogens in a single closed tube system and accommodate the higher throughput required to respond to seasonal changes in demand.

"We are excited to bring the RUO version of the NxTAG Respiratory Pathogen Panel to market," said Homi Shamir, president and CEO of Luminex. "Luminex introduced multiplexed respiratory panels to the clinical market in 2008, and our customers are anxiously awaiting a next-generation product that delivers expanded panel coverage and a simple closed tube workflow, combined with the throughput and quality of results established by the xTAG Respiratory Viral Panel. We are also pleased to report that we remain on track with our NxTAG clinical trials schedule which started in the first quarter of the year, and we expect the FDA submission to occur in the summer of 2015."

The NxTAG Respiratory Pathogen Panel requires only minutes of hands-on time and no upstream reagent preparation. Extracted samples are added directly to pre-plated, lyophilized reagents. The tubes are then sealed and ready for closed tube amplification and subsequent detection using the Luminex MAGPIX instrument.

The innovative tube strip design offers laboratories the flexibility to manage variable sample demand by processing a single sample or up to 96 samples per run without wasting consumables or reagents. The NxTAG Respiratory Pathogen Panel total turnaround time is approximately three hours for 96 samples (excluding extraction). The accompanying SYNCT Software provides a comprehensive approach to data analysis and reporting, and integrates the NxTAG Respiratory Pathogen Panel easily into any laboratory.

Clinical trials for the NxTAG Respiratory Pathogen Panel are in progress in the US.

To learn more or request a demo, visit luminexcorp.com/nxtag.
RUO products are for Research Use Only. Not for use in diagnostic procedures.

Why Test for Respiratory Pathogens?
Many commonly encountered respiratory pathogens (viral and bacterial) have similar clinical presentation, making diagnosis based on symptoms alone very difficult. Influenza viruses commonly cause respiratory illness, but many other pathogens may cause significant impact on patient health as well. Respiratory syncytial virus (RSV), as one example, is the most common cause of severe respiratory illness in young children as well as a leading cause of death from respiratory illness in those aged 65 years and older, according to the Centers for Disease Control and Prevention.

A clinician needs to accurately detect the respiratory pathogen causing illness in the patient in order to effectively prescribe treatment and control the spread of infection. Laboratories need respiratory assays that can rapidly and efficiently detect these relevant pathogens with minimal hands-on time and no post-PCR handling to meet laboratory, physician, and patient needs.

Source: Luminex Corporation, luminexcorp.com

Released: 04/01/15

Publication of Phase II Results in Adults with Anaplastic Astrocytoma

Burzynski Research Institute Inc., a biopharmaceutical company dedicated to the development and commercialization of novel therapies for patients with rare brain tumors and other cancers, has announced the publication of data by the Burzynski Clinic on two of the company’s clinical stage products: Antineoplaston A10 injections (Atengenal) and Antineoplaston AS2-1 injections (Astugenal). Antineoplastons A10 and AS2-1 are synthetic amino acid derivatives.

The phase II, single-arm, two-stage, interventional trial was conducted in the United States and evaluated adults with newly diagnosed anaplastic astrocytoma (AA). The study was closed for admission after enrollment of 19 adults out of a planned 40 patients, as the goal for complete response had been met in four study eligible patients. Progression-free survival (PFS) and overall survival (OS) at 1, 2, 3, 5, and 10 years are presented. A small number of patients experienced serious, but reversible, Grade 3 and 4 toxicities, including hypernatremia, hypokalemia, and somnolence. No chronic toxicities were noted.

The publication, entitled “A Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients with Newly-Diagnosed Anaplastic Astrocytoma,” was published in Cancer and Clinical Oncology 2015; 4(1):28-38.

Source: Burzynski Research Institute Inc.