(Filing, Annual, Can-Fite BioPharma, 2015, MAR 31, 2016, View Source [SID:1234510271])
On March 31, 2016 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported positive preclinical findings generated using the Company’s Immune Repertoire Capture technology, presented at the Gordon Research Conference: Antibody Biology & Engineering, which took place in Galveston, TX, March 20-25, 2016 (Press release, Atreca, MAR 31, 2016, View Source [SID1234522967]). In a poster titled, "Protective Anti-Malarial Human Antibodies identified from P. falciparum CSP Immunized Kymice using Immune Repertoire Capture (IRC)", a research team including scientists at Atreca and collaborators at leading institutions reported key preclinical research findings, including:
Atreca’s Immune Repertoire Capture technology applied in combination with Kymab’s Kymice, an Ig-gene humanized mouse platform, identified and generated potent antibodies comprised of human variable genes.
•Atreca identified diverse lineages (or families) of antibodies that bind to a key target, the circumsporozoite protein (CSP) of P. falciparum. Two of these lineages provided potent protection in an in vivo malaria-challenge model, resulting in >99% reduction of liver-stage parasite load.
Daniel Emerling, Ph.D., Atreca’s Senior Vice President, Research, stated, "IRC enabled identification of multiple lineages containing potent, anti-malarial human antibodies generated by activated mouse B cells. The diversified antibody library that we generated had a high hit rate of binding against the CSP target (34%). Our analyses also provide the foundation for understanding structure-activity relationships that mediate the binding of the antibodies that are efficacious in vivo. Furthermore, we have identified many other antibody sequences in these and other lineages that are highly similar to the efficacious antibodies and may therefore also be active in vivo."
Dr. Emerling continued, "We are grateful to both the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative for supporting this critical research."
"These results disclosed at the Gordon Conference demonstrate the ability of Atreca’s Immune Repertoire Capture technology to generate novel antibodies with high in vivo potency from immune responses, as well as multiple lineages containing such antibodies," commented Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-Founder. "While our primary focus continues to be on cancer immunotherapy, our IRC technology allows us to mine the key phenomenon driving efficacious immune responses in humans and animals in diverse disease settings, including infectious and autoimmune diseases."
Atreca recently reported use of its Immune Repertoire Capture technology to analyze the successful anti-tumor responses in individuals with non-progressing lung adenocarcinoma. Based on this and related research, select antibodies discovered by Atreca have progressed to preclinical testing in in vivo models of cancer, with the goal of selecting candidates to enter into more advanced preclinical studies.
On March 31, 2016 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted therapies for cancer and diabetes using its live-cell encapsulation technology, Cell-in-a-Box, reported the final design of its clinical trial for patients with advanced pancreatic cancer (Press release, PharmaCyte Biotech, MAR 31, 2016, View Source [SID:1234510778]). The clinical trial design was developed with Translational Drug Development (TD2), America’s premier oncology Contract Research Organization, as well as with renowned pancreatic cancer specialists consulting with PharmaCyte.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, "The trial is designed to determine if PharmaCyte’s pancreatic cancer treatment (the combination of micro-capsules that contain genetically modified human cells which convert the cancer prodrug ifosfamide into its "cancer-killing" form at one-third the normal dose) can satisfy a clear unmet medical need that exists for patients with locally advanced, inoperable pancreatic cancer who no longer respond to the current standard of care. Most of these patients are initially treated with the combination of nab-paclitaxel (Abraxane) plus gemcitabine or the four-drug combination known as FOLFIRINOX. When these patients’ tumors no longer respond to treatment with these regimens, the next standard of care offers little to no benefit. It is then that these patients are often treated with the combination of the anticancer drug capecitabine plus radiation therapy. However, this combination is only marginally effective in stopping the progression of the disease. In PharmaCyte’s clinical trial, our pancreatic cancer therapy will be compared "head to head" with the capecitabine/radiation combination to demonstrate that it is clearly superior in treating these patients while maintaining a superior quality of life during the therapy."
Major factors in the overall trial design are:
The clinical trial will be international (United States, Europe and possibly Australia), multi-site, open-label and randomized.
Study sites under consideration in the United States include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center and the Dana-Farber Cancer Institute both in Boston, Massachusetts, the Baylor Cancer Center in Dallas, Texas, the City of Hope Cancer Center in Los Angeles, California, and sites in Germany and Spain.
The randomization ratio of patients between the two study groups will be 1:1 (an equal number of patients will be randomly assigned to the capecitabine + radiation group and the PharmaCyte pancreatic cancer therapy group).
As many as 84 patients will be required to complete the study, although fewer may be required based upon the data developed during the trial.
Only patients who have locally advanced, non-metastatic, inoperable cancers and whose tumors no longer respond after 4-6 months of treatment with either the nab-paclitaxel (Abraxane) + gemcitabine or FOLFIRINOX regimens will be eligible for the study.
Unlike the earlier clinical trials using PharmaCyte’s pancreatic cancer therapy where patients received only two doses of ifosfamide, multiple cycles of ifosfamide will be given to those being treated with PharmaCyte’s pancreatic cancer therapy. This will continue until the patients’ tumors no longer respond to PharmaCyte’s therapy or until treatment-related toxicity accumulates to unacceptable levels.
Mr. Waggoner concluded, "We feel that the major factors that needed to be considered for the development of a complete clinical trial protocol have now been addressed. Of course, as we continue to move toward our clinical trial, slight changes that benefit the overall trial design could certainly be addressed and lead to further refinement of the trial. Special appreciation for reaching this point must be given to the renowned pancreatic cancer experts who have played such a major role in the trial design. With these developments, we are yet another step closer to the commencement of our clinical trial which we believe will satisfy the clear unmet medical need experienced by patients with locally advanced, but inoperable, pancreatic cancer who no longer respond to the gold standard of care."
On March 31, 2016 Cancer Research UK reported that scientists have discovered why a curable type of children’s brain tumour is so responsive to chemotherapy – paving the way to improve treatment of tumours that are harder to tackle, according to research by a Cancer Research UK scientist published in Cancer Cell* (Press release, Cancer Research UK, MAR 31, 2016, View Source [SID:1234510278]).
"This could make chemotherapy even more effective and reduce the amount of radiation that we give to children." – Professor Richard Gilbertson
This study shows that a curable type of brain tumour in children – called WNT medulloblastoma** – grows ‘leaky’ blood vessels that allow much higher than normal levels of chemotherapy drugs to reach the cancer cells.
Healthy blood vessels in the brain can filter potentially damaging molecules and prevent them from reaching brain tissue. But this can also restricts drugs from reaching tumour cells in the brain.
But in a tumour with leaky blood vessels, like certain types of medulloblastoma, these molecules cannot be kept out.
Understanding why curable tumours are easier to treat could help find more effective treatments for less curable types of medulloblastoma. For these patients, researchers think they might be able to turn this barrier off and make the tumours more responsive to chemotherapy.
Professor Richard Gilbertson, lead author who has recently joined Cancer Research UK’s Cambridge Institute, said: "This research is exciting because it means that as well as finding kinder treatments for a curable type of brain tumour, we may also be able to manipulate brain tumours that are difficult to treat successfully to make them more responsive to treatment.
"This could make chemotherapy even more effective and reduce the amount of radiation that we give to children. This would mean fewer long term side effects for children later in life which is something we’re always working towards."
Professor Pamela Kearns, Cancer Research UK’s children’s cancers expert, said: "This research gives us valuable insight into why some brain tumours respond better to chemotherapy than others. While cancer survival overall has doubled over the past 40 years, treatments for brain tumours have seen much slower progress. And brain tumours in children remain a major challenge.
"Cancer Research UK have made these challenges areas of priority and set up a specific Kids & Teens campaign to increase the investment in research focussed on children’s cancers. More research is needed to help us find ways to diagnose and treat the disease earlier and develop more effective treatments that have less of the long term side effects that can have a major impact throughout a child’s adult life."
This research was funded by ALSAC and the National Cancer Institute and carried out at St Jude Children’s Research Hospital.
On March 31, 2016 Medtronic plc (NYSE: MDT) reported that the U.S. Food and Drug Administration (FDA) cleared PillCam(TM) COLON 2 capsule for an expanded indication for use (Press release, Medtronic, MAR 31, 2016, View Source;p=RssLanding&cat=news&id=2152086 [SID:1234510245]). The PillCam(TM) COLON 2 capsule is the only non-invasive diagnostic test that directly visualizes the colon for the evaluation of polyps in patients who are at major risks for colonoscopy or moderate sedation. The PillCam(TM) capsule- a vitamin-sized capsule endoscope that is taken orally – does not require sedation, anesthesia or radiation, which makes it a more convenient procedure than other invasive colon exams.
This expanded indication is for the detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower gastrointestinal (Gl) origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.
Colon cancer is the third most commonly diagnosed cancer and second leading cause of cancer death in both men and women combined in the U.S. An estimated 136,000 people will be diagnosed with colorectal cancer each year, but when it is caught at a localized stage, the overall 5-year survival rate is 90%.[i]
According to Gastrointestinal Endoscopy, 14 million colonoscopiesare performed in the U.S. each year – of these, more than 3 million are performed for lower GI bleeding, and 600 thousand of those patients are at elevated risk for complications. [ii] [iii]
"The ability to offer PillCam COLON capsule to an expanded patient group represents a significant breakthrough in GI healthcare," said Douglas Rex, M.D., Distinguished Professor of Medicine and Chancellor’s Professor, Indiana University School of Medicine and Director of Endoscopy, IU Health University Hospital. "The new indication allows gastroenterologists to provide their at-risk patients with a non-invasive and radiation free alternative to traditional colonoscopy."
"We are committed to the early detection and treatment of chronic GI diseases and cancers. We are pleased with the FDA’s decision to clear this expanded indication for PillCam(TM) COLON capsule which will provide access to more patients who can benefit from this technology," said Vafa Jamali, president, Early Technologies business in the Medtronic Minimally Invasive Therapies Group.
PillCam(TM) COLON 2 capsule was previously cleared by the FDA for visualization of the colon and the detection of colon polyps in patients following an incomplete colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. The PillCam(TM) capsule technology may also limit the risk of complications that could occur from a standard colonoscopy, such as colon perforation, bleeding or cardio-pulmonary complications.