In the News
Burzynski Research Institute, Inc. Announces Publication of Phase II Results in Patients with Non-Diffuse Intrinsic Pontine Glioma
Study Finds Lipid-Based Vitamin D Formulation Boosts Blood Levels
According to a Life Extension Clinical Research Inc. study, switching to a lipid-based softgel formulation containing 5,000 IU of vitamin D3 led to a statistically significant 28.5 percent increase in 25(OH) D blood levels among healthy adults who had been taking 5,000 IU of a dry powder-based vitamin D3.
The study, titled "An open-label study to evaluate the effect of 5,000 IU of vitamin D3 softgel on serum 25-hydroxyvitamin D levels among healthy adults," was presented at the Experimental Biology Scientific Conference in Boston, Massachusetts on March 29, 2015. The annual scientific meeting is comprised of more than 14,000 scientists and exhibitors representing six sponsoring societies and multiple guest societies with interest in research and life sciences.
The researchers—Steven P. Hirsh, RPh, DPM, MHSA; Luke G. Huber, ND, MBA; Kira Schmid, ND; Judith Woolger, MD; and Steven V. Joyal, MD—set out to determine if a lipid-based softgel vitamin D supplement could boost vitamin D blood levels in healthy adults who had already been taking a dry, powder-based vitamin D capsule at the same dosage for at least 3 months.
After discontinuing their dry powder-based vitamin D3 capsules, 16 participants were instructed to take a lipid-based softgel formulation containing 5,000 IU vitamin D3 for 60 days. Blood levels of 25(OH) D were measured at baseline (prior to vitamin D3 softgel ingestion), day 30, and day 60.
Fifteen participants completed the study. No serious adverse events were reported. Compared with baseline measurements, blood levels of 25(OH) D increased by 16 percent by day 30 and 28.5 percent by day 60. The results were statistically significant.
Dr. Steven Hirsh, director of clinical research at Life Extension Clinical Research Inc., notes this study helps answer an important question about the optimal delivery method for vitamin D supplementation.
"One of the key considerations is the impact of different delivery vehicles, especially powders and oils, on nutrient bioavailability," says Dr. Hirsh. "Our findings suggest a lipid-based vitamin D formulation may be superior to a dry powder-based product and provides a rationale for further research in this area."
The form of vitamin D used for this study was cholecalciferol (vitamin D3)—the natural form of vitamin D that the body makes in response to sunlight. Vitamin D has received significant research attention over the past decade and is known to play a critical role in calcium and phosphorus homeostasis, bone mineralization, and skeletal growth. A low level of vitamin D has been linked to various diseases, including cancer, cardiovascular disease, and autoimmune disease.
Source: Life Extension, lef.org
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.
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
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 CancerSelectTM 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).
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.
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
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
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.