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In year two, MD Anderson Moon Shots Program begins to generate innovations
Source Press Release
Company The University of Texas MD Anderson Cancer Center, Cancer Advances
Date October 30, 2014
In year two, MD Anderson Moon Shots Program begins to generate innovations
HOUSTON, Oct. 30, 2014 /PRNewswire-USNewswire/ -- Improved surgical outcomes for ovarian cancer, expanded potential impact for new drugs, and a novel family outreach program to head off cancers fueled by known genetic risk mutations are among the early innovations of The University of Texas MD Anderson Cancer Center's Moon Shots Program.
First-of-a-kind combination clinical trials; advanced molecular analysis to guide treatment and screening; and a focused program to gather, store, access and apply massive amounts of information to help patients and learn along the way also are unfolding.
"Our Moon Shots Program presses on to save more lives more quickly by cultivating powerful, efficient connections between vast new scientific knowledge and our efforts to improve patient care, protect those at risk and prevent cancer outright," MD Anderson President Ron DePinho, M.D., said.
"Moon shots gather MD Anderson's multidimensional expertise and tap remarkable new technologies to better deploy what we already know about cancer against these diseases and to contribute creative new answers to crucial challenges," he said.
The program was launched in fall 2012 to accelerate the conversion of scientific discoveries into clinical advances and significantly reduce cancer deaths. The initial moon shots address melanoma, lung, prostate and breast/ovarian cancers as well as chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS).
Moon shots research benefits from innovative platforms in immunotherapy, genomics, proteomics, prevention and big data, as well as support by MD Anderson's Center for Co-Clinical Trials and Institute for Applied Cancer Science.
Ovarian and Breast Cancer Moon Shot
Personalized surgery: A new algorithm has been developed to determine whether ovarian cancer patients should go to surgery upfront or have chemotherapy first. The independent assessment by two oncologists via less-invasive laparoscopy has tripled the rate of complete surgical removal of tumors, which is strongly associated with improved survival.
Family outreach to head off cancer: Universal screening of high-grade serous ovarian cancer and triple-negative breast cancer patients for BRCA 1 and 2 mutations allows outreach to patients' families offering screening for these inherited cancer-risk mutations and preventive options when appropriate.
Lung Cancer Moon Shot
Leukemia drugs, lung cancer targets: Researchers identified two drugs previously approved for treating leukemia that potentially hit lung cancer targets in some patients. A clinical trial of one, the targeted therapy ibrutinib, is underway for patients with treatment-resistant disease and specific mutations in the epidermal growth factor receptor (EGFR).
Better screening to catch cancer early: A study opened to address the major challenges in lung cancer CT screening - - identifying who among the nation's millions of current and former smokers should be screened and managing the high false-positive rate of CT findings. Plans are to extend the study globally in 2015.
Chronic Lymphocytic Leukemia Moon Shot
Easing out chemotherapy: MD Anderson CLL Moon Shot experts were instrumental in the development of the targeted therapies ibrutinib and idelalisib, both approved in 2014 for CLL by the U.S. Food and Drug Administration. These and other drugs such as the antibody rituximab induce long-term responses with fewer and less harsh side effects than chemotherapy. Only 15 percent of new CLL patients at MD Anderson are treated with chemotherapy, down from 48 percent two years ago.
Targeting CLL with customized T cells: The moon shot opened three first-in-human clinical trials this year deploying state-of-the art engineered immune cells designed to find and destroy leukemia cells. Two involve customized T cells, the attack cells of the adaptive immune system. One customizes a patient's own T cells, the other transplants T cells derived from umbilical cord blood.
Prostate Cancer Moon Shot
Intent-to-cure drug combination trial:Researchers have paired two drugs designed to thwart androgen receptor-driven, castrate-resistant prostate cancer in the first intent-to-cure clinical trial for a subgroup of prostate cancer patients. The drugs abiraterone and enzalutamide target the androgen receptor-testosterone pathway in different ways to reduce male hormone levels. Moon shots researchers found that the combination of the drugs thwarts the resistance pathways that arise against them singly.
New combinations: Preclinical studies found specific drug combinations that include agents that target the androgen receptor pathway and agents that target the DNA damage response pathway are more effective than either treatment alone.
Melanoma Moon Shot
Presurgical targeted drug combination: Moon shot investigators launched the first clinical trial to compare presurgical treatment with a targeted therapy combination to surgery alone for stage III melanoma. They're combining dabrafenib and trametinib, approved now for metastatic melanoma, as presurgical treatment to prevent recurrence. Additional clinical trials combine targeted therapy with immune checkpoint blockade drugs that unleash an immune system attack on tumors.
UV protection from preschool through adolescence: Researchers are developing an evidence-based sun protection program for preschoolers and promoting school-based efforts from kindergarten through high school. They're following up on successful efforts to limit tanning bed exposure by minors.
Acute Myeloid Leukemia/Myelodysplastic Syndromes
Overcoming drug resistance: Research on resistance to hypomethylating agents, an important class of drugs used to treat these diseases, has led to two novel clinical trials. One is the first conducted in leukemia of a rising type of cancer immunotherapy called immune checkpoint blockade, blocking PD-1. Another targets the toll-like receptor 2 protein (TLR2).
Attacking with cellular immune therapies: A new project explores approaches to improve blood stem cell transplants and, ultimately, replace them with engineered immune T cells and natural killer cells.
Energizing cancer advances
Philanthropic support for the Moon Shots Program remains strong in fiscal year 2014, with leaders in the energy industry and MD Anderson's Board of Visitors among the top supporters.
"We're sincerely grateful for those who are investing in new answers being developed by our moon shots for cancer patients and their families," DePinho said.
Major gift commitments include:
Exxon Mobil Corporation, $10 million
Shell Oil Company Foundation and Motiva Enterprises, $3 million
Apache Corporation, $2.5 million
Anadarko Petroleum Corporation, $1.5 million
William Webster IV, $1 million
Freeport-McMoRan Copper and Gold Foundation, $1 million
LyondellBasell Industries, $1 million
Steven Farris, $1 million
Lowry Mays, $1 million
As of Sept. 30, $212,991,178 had been raised for the Moon Shots Program.
SOURCE The University of Texas M. D. Anderson Cancer Center
FROM Yesterday:
• 30-Oct-2014 21:56 - PEREGRINE PHARMACEUTICALS INC- FAVORABLE TRENDS IN OVERALL RESPONSE RATES CONTINUE TO SUPPORT BAVITUXIMAB'S POTENTIAL IN NSCLC
PEREGRINE PHARMACEUTICALS INC- FAVORABLE TRENDS IN OVERALL RESPONSE RATES CONTINUE TO SUPPORT BAVITUXIMAB'S POTENTIAL IN NSCLC PPHM.O - RTRS
30-Oct-2014 21:56
PEREGRINE PHARMACEUTICALS INC- FAVORABLE TRENDS IN OVERALL RESPONSE RATES CONTINUE TO SUPPORT BAVITUXIMAB'S POTENTIAL IN NSCLC
Sorafenib News from Bayer HealthCare:
This is just the beginning of the german-news from their homepage:
http://healthcare.bayer.de/scripts/pages/de/index.php
Sorafenib als sichere und wirksame Therapie im Praxisalltag bestätigt
Der orale Multikinaseinhibitor Sorafenib (Nexavar®) ist Therapiestandard für Patienten mit Leberzellkarzinom (HCC) und die einzige für diese Entität zugelassene systemische Therapie. mehr
Sorafenib confirmed as safe and effective therapy in everyday practice
The oral multi-kinase inhibitor sorafenib ( Nexavar ) is standard therapy for patients with hepatocellular carcinoma ( HCC ) and the only approved systemic therapy for this entity .
breast or liver or breast and liver and both with bavi - time will tell
BMY
Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in Heavily Pre-treated Advanced Squamous Cell Non-Small Cell Lung Cancer to be Presented at the 2014 Chicago Multidisciplinary Symposium on Thoracic On BMY.N - BSW
30-Oct-2014 14:00
• In CheckMate -063, the objective response rate was 15% in patients treated with single agent Opdivo and median duration of response was not reached
• 41% of Opdivo-treated patients were alive at one year
• Types and frequency of treatment-related adverse events were consistent with early clinical experience and managed using recommended treatment algorithms
• Rolling submission initiated with FDA in April based on CheckMate 063; company expects to complete submission by year end
PRINCETON, N.J.--(Business Wire)-- Bristol-Myers Squibb Company (NYSE:BMY) today announced results from CheckMate -063, a Phase 2 single-arm, open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, administered as a single agent in patients with advanced squamous cell non-small cell lung cancer (NSCLC) who have progressed after at least two prior systemic treatments with 65% receiving three or more prior therapies (n=117). With approximately 11 months of minimum follow up, the objective response rate (ORR, the study`s primary endpoint) was 15% (95% CI = 8.7, 22.2) as assessed by an independent review committee (IRC) using RECIST 1.1 criteria and the median duration of response was not reached. The estimated one-year survival rate was 41% (95% CI = 31.6, 49.7) and median overall survival (mOS) was 8.2 months (95% CI = 6.05, 10.91). These data will be presented during the Plenary Session at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology on October 31 (Abstract #3462).
"The Phase 2 findings from CheckMate -063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies," said Suresh S. Ramalingam, MD, Professor and Director of Medical Oncology, Winship Cancer Institute of Emory University. "The results are also consistent with Phase 1 data previously reported from Study -003." Historically, the expected one-year survival rate for third-line squamous cell NSCLC patients is approximately 5.5% - 18%.1,2
Grade 3-4 drug-related adverse events (AEs) were reported in 17.1% of patients. The most common Grade 3-4 AEs (greater than or equal to 2%) were fatigue (4.3%), pneumonitis (3.4%), and diarrhea (2.6%). Discontinuations due to drug-related AEs of any grade occurred in 12% of patients and there were two drug-related deaths in patients with multiple comorbidities and in the setting of progressive disease.
"Results from CheckMate -063 offer further clinical evidence of the potential of immuno-oncology as an innovative approach to treating this disease," said Michael Giordano, senior vice president, Head of Development, Oncology. "We are committed to addressing the significant unmet medical needs of patients with lung cancer and have the broadest development program evaluating our approved and investigational immuno-oncology agents across multiple lines of therapy and histology."
Bristol-Myers Squibb`s lung cancer research and development program is evaluating its approved and investigational immunotherapies - either as single agents or as part of combination regimens - across lines of therapy, histologies and biomarker expression. Among these are six ongoing Phase 3 trials. Four Phase 3 trials are evaluating Opdivo (nivolumab) as a single agent - three in previously treated patients (CheckMate -017, CheckMate -057 and CheckMate -153 ) and one in chemotherapy-naïve patients (CheckMate -026). Two Phase 3 trials evaluating Yervoy in combination with chemotherapy in newly diagnosed small cell lung cancer (Study -156) and squamous cell NSCLC (Study -104) are ongoing.
Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trademark for nivolumab.
About the Checkmate -063 Trial Design & Detailed Results
Checkmate -063 is a Phase 2 single arm, open-label study designed to assess advanced squamous cell NSCLC patients who progressed after both platinum-based therapy and at least one additional systemic therapy with an ECOG Performance Status of 0 or 1 who were treated with Opdivo as a single agent 3mg/kg by intravenous infusion every two weeks until disease progression or treatment discontinuation (n=117). The primary endpoint was ORR as assessed by an IRC using RECIST 1.1 criteria. Responders were further characterized by duration of response. Secondary endpoints included investigator-assessed ORR. Overall survival, PFS and efficacy by PD-L1 expression status were exploratory endpoints. All treated patients had received at least two prior systemic regimens with 65% receiving greater than or equal to three prior therapies. Seventy-six percent of patients were within three months of completion of their most recent therapy. The best response to the most recent prior systemic therapy was progressive disease in 61% of patients.
With approximately 11 months of minimum follow up, the ORR was 15% (95% CI = 8.7, 22.2) as assessed by an IRC using RECIST 1.1 criteria and the median duration of response was not reached. The estimated one-year survival rate was 41% (95% CI = 31.6, 49.7) and mOS was 8.2 months (95% CI = 6.05, 10.91). An additional 26% of patients had stable disease with a median duration of six months (95% CI, 4.73, 10.91) giving a disease control rate (defined as partial response + stable disease) of 41%. For patients with quantifiable PD-L1 expression, responses were observed independent of PD-L1 status.
Grade 3-4 drug-related AEs were reported in 17.1% of patients. The most common (greater than or equal to 2%) Grade 3-4 AEs were fatigue (4.3%), pneumonitis (3.4%), and diarrhea (2.6%). Drug-related AEs generally were manageable with corticosteroids and/or supportive care as per established safety algorithms. Discontinuations due to drug-related AEs of any grade occurred in 12% of patients and there were two drug-related deaths in patients with muliple comorbidities and in the setting of progressive disease.
About Opdivo (nivolumab)
Cancer cells may exploit "regulatory" pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 35 trials - as monotherapy or in combination with other therapies - in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in NSCLC, melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
In 2013, the FDA granted Fast Track designation for Opdivo in NSCLC, melanoma and RCC. In April 2014, the company initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC based on CheckMate -063 and expects to complete the submission by year-end. The FDA granted Opdivo Breakthrough Therapy Designation in May 2014 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4, Ono Pharmaceutical Co. announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, making Opdivo the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. On September 26, Bristol-Myers Squibb announced that the FDA accepted for priority review the Biologics License Application for previously treated advanced melanoma, and the Prescription Drug User Fee Act (PDUFA) goal date for a decision is March 30, 2015. The FDA also granted Opdivo Breakthrough Therapy status for this indication. In the European Union, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for Opdivo in advanced melanoma and lung cancer. The advanced melanoma application has also been granted accelerated assessment by the EMA`s Committee for Medicinal Products for Human Use (CHMP).
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year according the World Health Organization. NSCLC is one of the most common types of the disease and accounts for approximately 85 percent of cases. Survival rates vary depending on the stage and type of the cancer when it is diagnosed. Globally, the five-year survival rate for Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC, the five-year survival rate drops to two percent. Historically, the expected one-year survival rate for third-line squamous cell NSCLC patients is approximately 5.5% - 18%.i, ii
Immuno-Oncology at Bristol-Myers Squibb
Promising Data Presented at the Chicago Multidisciplinary Symposium on Thoracic Oncology From an Investigator-Sponsored Trial of Peregrine Pharmaceuticals' Bavituximab in Combination With Pemetrexed and Carboplatin in Front- PPHM.O - MKW
30-Oct-2014 14:42
For best results when printing this announcement, please click on the link below:
http://pdf.reuters.com/pdfnews/pdfnews.asp...
Promising Data Presented at the Chicago Multidisciplinary Symposium on Thoracic Oncology From an Investigator-Sponsored Trial of Peregrine Pharmaceuticals' Bavituximab in Combination With Pemetrexed and Carboplatin in Front-Line Non-Small Cell Lung Cancer
Favorable Trends in Both Overall Response Rates of 35% and Median Overall Survival of 12.2 Months Continue to Support Bavituximab's Potential in NSCLC
Lead Immuno-Oncology Antibody Bavituximab in a Phase III Trial in Patients With Previously Treated Non-Small Cell Lung Cancer
TUSTIN, CA--(Marketwired - Oct 30, 2014) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), today announced the presentation of data from the Phase Ib investigator-sponsored trial (IST) of its immunotherapy bavituximab in combination with the chemotherapies pemetrexed and carboplatin in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Data from this single-arm, open-label, multi-center trial show an overall tumor response (ORR) of 35%, a median progression-free-survival (PFS) of 4.8 months, and a median overall survival (OS) of 12.2 months. Favorable trends in ORR and OS continue to support bavituximab's potential in NSCLC.1-4 These data are presented in a poster session at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology being held at the Marriott Downtown Chicago Magnificent Mile in Chicago, Illinois.
"While we continue to advance our SUNRISE Phase III trial in second-line NSCLC, data from this front-line trial are intriguing and warrant further investigation in a larger trial setting," said Joseph Shan, vice president of clinical and regulatory affairs of Peregrine. "These recent data add to the growing body of favorable combination data generated with bavituximab and chemotherapy agents as well as complementing the preclinical data emerging from our immuno-oncology program combining bavituximab with immune checkpoint inhibitors."5-8
The poster titled: "A Phase Ib Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy Naïve Stage IV Non-Squamous Non-Small Cell Lung Cancer" will be presented by Juneko Grilley-Olson, M.D., principal investigator of the trial and assistant professor, Department of Medicine, Division of Hematology and Oncology at the University of North Carolina at Chapel Hill. Results from 23 evaluable patients with advanced non-squamous NSCLC showed that the combination of bavituximab, carboplatin and pemetrexed was well-tolerated and clinically active. In this single-arm trial, patients treated with bavituximab in combination with carboplatin and pemetrexed achieved an objective response rate (ORR) of 35% (95% confidence interval (CI): 16.4 - 57.3%) as measured in accordance with RECIST (Response Evaluation Criteria in Solid Tumors) criteria. In addition, data showed a current median PFS of 4.8 months (95% CI: 4.0 - 8.0 months) and a median OS of 12.2 months (95% CI: 8.0 - not estimable (NE) months). Most adverse events (AE) observed were consistent with the known safety profile of the chemotherapy agents with no dose-limiting toxicities (DLT) or unexpected AEs occurring. All patients experienced at least one AE. The most common treatment related AEs were thrombocytopenia, anemia, neutropenia, fatigue, nausea with most AEs being = Grade 2. The recommended Phase II dose of bavituximab in combination with carboplatin and pemetrexed is determined to be 3mg/kg.
Dr. Grilley-Olson stated: "I am pleased to be presenting these updated results to the oncology community given the encouraging data coming from this open-label trial in what is a difficult to treat disease. While these data come from a small number of patients the responses seen warrant further clinical examination including the conduct of randomized trials. In addition, the survival curve observed from this trial is consistent with those seen from other immunotherapy-based drug candidates."
Bavituximab is in Phase III development for the treatment of previously treated non-small lung cancer as part of the SUNRISE trial and is being evaluated in several solid tumor indications, including investigator-sponsored trials in breast cancer, liver cancer, rectal cancer and melanoma.
About the Phase Ib Trial
This is a Phase Ib, open-label, single-arm, multi-center trial in 26 patients with previously untreated, locally advanced or metastatic non-squamous NSCLC. These patients received up to six 21-day cycles of the drugs pemetrexed and carboplatin with weekly bavituximab (3 mg/kg) until progression or toxicity. The primary endpoints of the trial were to determine the safety, dose-limiting toxicity (DLT) and recommended Phase II dose of bavituximab in combination with carboplatin and pemetrexed in advanced non-squamous NSCLC. Secondary endpoints included assessment of overall response rate (ORR) measured by RECIST criteria, progression-free survival (PFS) and overall survival (OS).
More information on this trial can be found at www.ClinicalTrials.gov using Identifier NCT01323062.
The link to the poster can be found from the front page of the company's website at: www.peregrineinc.com.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of previously treated non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that results from later stage clinical trials may not correlate to the results from earlier stage clinical trials. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2014 as well as any updates to these risk factors filed from time to time in the company's other filings with the Securities and Exchange Commission. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
1 Shtivelband M. et al. "Randomized, blinded, placebo-controlled phase II trial of docetaxel and bavituximab as second-line therapy in locally advanced or metastatic non-squamous non-small cell lung cancer." J Clin Oncol 31, 2013 (suppl; abstr 8095)
2 Chalasani P et al. Phase I clinical trial of bavituximab (Bavi) and paclitaxel (P) in patients (pts) with HER2-negative metastatic breast cancer (MBC). J Clin Oncol 31, 2013 (suppl; abstr 567)
3 Raghunadharao D. et al Bavituximab plus paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer Lung Cancer. Published Online: August 23, 2014 DOI: http://dx.doi.org/10.1016/j.lungcan.2014.08.010
4 Peregrine Pharmaceuticals. Peregrine Reports Promising 20.7 Month Median Overall Survival From Phase II Advanced Breast Cancer Trial. N.p., 24 Aug. 2011. Web. 24 Aug. 2011
5 Brekken R. Antibody-mediated blockade of phosphatidylserine enhances the anti-tumor activity of immune checkpoint inhibitors by affecting myeloid-derived suppressor cell (MDSC) and lymphocyte populations in the tumor microenvironment. Presentation at Cancer Research Institutes' "Cancer Immunotherapy: Out of the Gate" conference October 6, 2014. New York, New York
6 Hutchins J. Phosphatidylserine (PS)-Targeting Antibodies Enhance Activity of Immune Checkpoint Inhibitors by Repolarizing Immunosuppressive Immune Cells Populating the Tumor Microenvironment. Presentation at Cambridge Healthcare Institute's ImVacS 9th Annual Immunotherapies & Vaccine Summit. August 11, 2014. Boston, Massachusetts
7 Huang X et al. Phosphatidylserine-targeting antibody synergizes with anti-PD-1 antibody to inhibit tumor growth in K1735 mouse melanoma model. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl): Abstract nr LB-262. doi:10.1158/1538-7445.AM2014-LB-262
8 Gong J. et al, Targeting of phosphatidylserine by monoclonal antibodies enhances activity of immune checkpoint inhibitors in tumors. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl): Abstract nr 4978. doi:10.1158/1538-7445.AM2014-4978
Contact:
Christopher Keenan
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
© 2014 Marketwire L.P. All rights reserved.
68k at 1,58 AH
and again: Scott Antonia - Saturday November 1st, 10 a.m.
General Session VIII - Keynote III: Immune Modulation of Lung Cancer
Moderator: Everett E. Vokes, MD, The University of Chicago, Chicago
Speaker:
•Scott J. Antonia, MD, PhD, Moffitt Cancer Center, Tampa, Florida
Scott Antonia - Friday, October 31, 10:30 am
http://www.thoracicsymposium.org/MeetingProgram/Agenda.htm
http://www.peregrineinc.com/about-us/medical-and-scientific-advisors.html
Cologne-Page
insert-text-here
They are still recruiting!
i found a new italian page/document
https://www.cittadellasalute.to.it/albo/pubblicazione.xml#Delibere
Seach for: PPHM 1202, than you find a document at the right side (immagine)/ it is in line 1031
PDF-download
https://www.cittadellasalute.to.it/albo/Allegati/i_58701.pdf
Some news will flow in November - see slide Nr. 28 from AM 2014
J&J aims for 1 million Ebola vaccine doses in 2015
22-Oct-2014 10:47
• Companies racing to develop first approved Ebola vaccine
• J&J investing up to $200 mln to accelerate programme
• Bavarian Nordic to receive cash injection from J&J
• GSK and NewLink currently leading in vaccine development
(Adds Bavarian Nordic share price jump, further details)
By Ben Hirschler
LONDON, Oct 22 (Reuters) - Johnson & Johnson JNJ.N is accelerating work on its experimental Ebola vaccine and aims to produce 1 million doses next year, 250,000 of which are expected to be available by May.
There is currently no proven vaccine against the deadly disease but several companies are racing to develop products. Clinical tests on two - from GlaxoSmithKline GSK.L and NewLink Genetics NLNK.O - are already under way.
The World Health Organization (WHO) hopes that tens of thousands of people in West Africa, including frontline healthcare workers at high risk of infection, can start receiving Ebola vaccines from January as part of large-scale clinical trials. (Full Story)
J&J said on Wednesday that it would test its vaccine for safety and immune response in healthy volunteers in Europe, the United States and Africa from early January, adding that it will commit up to $200 million to accelerate the programme.
The J&J vaccine was discovered in collaboration with the U.S. National Institutes of Health (NIH) and includes technology from Denmark-based Bavarian Nordic BAVA.CO, which will now receive a cash injection from the American healthcare company.
The total potential deal value for Bavarian Nordic could be more than $187 million, including upfront payments, milestone payments based on product progress, a supply contract and the purchase by J&J of shares in the Danish biotech business.
Bavarian Nordic's share price jumped 19 percent in early trading after the announcement of J&J's plans.
SIMPLIFIED VACCINE
West Africa's Ebola outbreak began in March and has killed more than 4,500 people, most of them in Liberia, Sierra Leone and Guinea, according to the WHO. Outbreaks in Senegal and Nigeria have been declared over by the WHO and there have been a handful of cases in Spain and the United States.
J&J has simplified and fast-tracked its vaccine programme in the light of the world's worst Ebola outbreak, which is still ravaging the three worst-hit West African countries.
Originally it had been working to develop a vaccine against both the Zaire and Sudan strains of Ebola, as well as a related condition called Marburg disease.
That long-term programme will continue, but J&J is now also developing a vaccine targeting only the Zaire strain behind the current epidemic, which is a more straightforward project and should therefore yield results faster.
"We have an important responsibility as a leading global healthcare company to do all we can to address this urgent unmet medical need," J&J Chief Executive Alex Gorsky said in a statement.
The U.S. company added that it is also seeking additional partners and resources to assist in its efforts to increase vaccine production and speed the clinical trial programme.
PROMISING SIGN
Although the safety and effectiveness of J&J's and other experimental vaccines has yet to be proven, they have provided good protection against the Zaire strain of Ebola when tested on macaque monkeys, which is seen as a promising sign that they are likely to work in humans.
Like a number of experimental vaccines against various diseases, J&J's vaccine uses a common cold virus, called an adenovirus, to carry its payload.
Immunisation with the J&J vaccine, which was developed by its Crucell unit in the Netherlands, consists of two injections: one to prime the immune system and a second to boost the response. They were given two months apart in the monkey tests. By contrast, researchers are testing a single shot of GSK's vaccine.
How safe and effective J&J's product will be in humans remains to be seen, but more than 1,000 people have already received similar experimental vaccines from Crucell in clinical trials for other diseases with no apparent ill effects, offering some reassurance.
Bavarian Nordic, meanwhile, has used a similar approach in producing a smallpox vaccine that has been stockpiled around the world and tested on more than 7,000 people. (1 US dollar = 5.8566 Danish crown)
We are at 145
insert-text-here
bid 1,49 ask 1,49 ????
Spanish Nurse - Ebola
Romero is being treated with a combination of serum made up of antibodies extracted from Ebola survivors and anti-viral drugs.
No problem - buy more under 1,50
Joins list of Ebola bets
15-Oct-2014 14:48
** Drug developer's stock PPHM.O jumps 21.5 pct to $1.70 premarket after company says it will test its experimental antibody to treat Ebola (Full Story)
** Stock of several medical device and drug makers also up as a second Texas healthcare worker tested positive for Ebola (Full Story)
** Protective gear maker Versar Inc VSR.A up 34 pct premarket; face mask maker Alpha Pro tech Ltd APT.A up 19 pct; hazmat suits maker Lakeland Industries Inc LAKE.O up 16 pct
** Tekmira Pharmaceuticals Corp's U.S.-listed shares TKMR.O up 3 pct at 24.29 premarket, while biotechnology company Ibio Inc's IBIO.A shares up 3.6 pct
** Medical test maker Chembio Diagnostics Inc CEMI.O shares up 4 pct, while Medical waste management company Sharps compliance Corp SMED.O shares up 8 pct
** Shares of these small medical equipment and biotech companies fell on Tuesday after rally spurred by diagnosis of the first Ebola patient in U.S. on Sept. 30 (Full Story)
** Take A Look: World on alert to curb Ebola outbreak (Full Story)
15-Oct-2014 14:35 - PEREGRINE PHARMA UP 25 PCT TO $1.75 IN PREMARKET AFTER COMPANY SAYS BAVITUXIMAB EXHIBITS STRONG BINDING TO EBOLA-INFECTED CELLS IN VITRO
PEREGRINE PHARMA UP 25 PCT TO $1.75 IN PREMARKET AFTER COMPANY SAYS BAVITUXIMAB EXHIBITS STRONG BINDING TO EBOLA-INFECTED CELLS IN VITRO PPHM.O - RTRS
15-Oct-2014 14:35
1,84 PM high vol.
Alerts History
• 15-Oct-2014 14:08 - PEREGRINE PHARMACEUTICALS SAYS BAVITUXIMAB EXHIBITS SPECIFIC AND STRONG BINDING TO EBOLA VIRIONS AND EBOLA VIRUS (EBOV)-INFECTED CELLS IN VITRO
PEREGRINE PHARMACEUTICALS SAYS BAVITUXIMAB EXHIBITS SPECIFIC AND STRONG BINDING TO EBOLA VIRIONS AND EBOLA VIRUS (EBOV)-INFECTED CELLS IN VITRO PPHM.O - RTRS
15-Oct-2014 14:08
PEREGRINE PHARMACEUTICALS SAYS BAVITUXIMAB EXHIBITS SPECIFIC AND STRONG BINDING TO EBOLA VIRIONS AND EBOLA VIRUS (EBOV)-INFECTED CELLS IN VITRO
1,73 PM !!!!
Data to Be Published in the Journal of Immunology Research Support Phosphatidylserine (PS) as a Potential Target in Ebola Infection PPHM.O - MKW
15-Oct-2014 14:00
For best results when printing this announcement, please click on the link below:
http://pdf.reuters.com/pdfnews/pdfnews.asp...
Data to Be Published in the Journal of Immunology Research Support Phosphatidylserine (PS) as a Potential Target in Ebola Infection
Peer-Reviewed Data Show Peregrine Pharmaceuticals' PS-Targeting Antibody Bavituximab Exhibits Specific and Strong Binding to Ebola Virions and Ebola Virus-Infected Cells In Vitro; Data Supplement Published Scientific Literature Suggesting the Important Role of PS in Ebola Infection in Viral Entry and Immune Suppression During Infection
TUSTIN, CA--(Marketwired - Oct 15, 2014) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), today announced the publication of a peer-reviewed manuscript related to preclinical research demonstrating that the company's lead drug candidate bavituximab, a phosphatidylserine (PS)-targeting antibody, exhibits specific and strong binding to Ebola virions and Ebola virus (EBOV)-infected cells in vitro. These results will appear in the Vaccines and Therapies for Biodefense Agents special edition of the peer-reviewed Journal of Immunology Research in a manuscript titled: "Effective Binding of a Phosphatidylserine-Targeting Antibody to Ebola Virus Infected Cells and Purified Virions."
"The recent outbreaks of Ebola infections highlight the need for novel clinical treatments and new combinations that are effective in treating the disease. We have a number of active collaborations exploring the potential of PS-targeting antibodies in infectious diseases and the results just published, along with a growing body of scientific literature, support potential applications of our PS-targeting platform in virus infections including Ebola," said Jeff T. Hutchins, Ph.D. vice president, preclinical research at Peregrine Pharmaceuticals. "Evolution has favored pathogenesis that exposes PS and these published results, along with other recently to be published data, have shown that PS is present during Ebola virus infection1-3 and is important in the infection process. While our primary focus remains on advancing bavituximab in oncology, including our SUNRISE Phase III lung cancer trial, we believe these data warrant further collaborative investigation in Ebola and other infectious diseases including combinations with vaccines and active therapies that have shown promise."
The manuscript details the results from a study demonstrating that exposed PS allows for the specific binding of bavituximab to purified Ebola virions and EBOV-infected cells in vitro. Previous published studies have shown that surface exposure of PS antigen is a consequence of viral infection. Published results in other lethal viral hemorrhagic fever animal model (Pichinde virus infection model in guinea pigs)5 suggest that PS-targeting antibodies can bind to exposed PS and limit viral infection by initiating the removal of virions from the bloodstream through the induction of antibody-dependent cellular cytotoxicity (ADCC) as well as eliminate virus-infected cells.
"Our goal with this work was to continue exploring the potential of bavituximab in the antiviral arena and in this case, specifically in biodefense applications," said Cyril Empig, Ph.D., associate research director at Peregrine Pharmaceuticals. "With the increased focus on Ebola, there is an opportunity to take advantage of the specificity of bavituximab for Ebola virus and develop therapeutics or treatment regimens that could neutralize the virus. In addition, recently reported genomic sequence variations in EBOV suggest that drugs targeting specific viral non-variant proteins or protein sequences are at risk of failure as a result of virus escape mutations.4 We believe that there are advantages to utilizing bavituximab in a treatment regimen against Ebola virus given its great specificity for Ebola virions and Ebola-infected cells, its potential to circumvent the problem of virus escape mutations given that it is targeting a host molecule rather than a virus protein or protein sequence, and the possible role of PS in immunosuppression during Ebola infection.1 Given these data, we are developing a plan to explore potential applications of bavituximab and PS-targeting antibodies in the treatment of Ebola."
A link to the provisional manuscript can be found on the front page of the company's website at www.peregrineinc.com
About Bavituximab: A Targeted Immunotherapy
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. To date, bavituximab has been administered to over 600 patients worldwide and appears to be safe and well tolerated. Bavituximab's target, PS, is a highly immunosuppressive lipid molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of virus-infected cells, virus particles themselves, as well as tumor cells and cells that line tumor blood vessels, creating a specific target for anti-viral and anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal potentially enabling the immune system to better recognize and fight tumors and infectious pathogens. Data published in peer-reviewed journals shows that PS-targeting antibodies such as bavituximab mediate important immune-stimulatory changes.5,6 As part of the SUNRISE trial, bavituximab is being evaluated in a Phase III, global, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab plus docetaxel as second-line treatment in patients with non-small cell lung cancer. Bavituximab is also currently being evaluated in several solid tumor indications, including breast cancer, liver cancer, rectal cancer and melanoma. For additional information about the SUNRISE trial
please visit www.SunriseTrial.com or www.ClinicalTrials.gov using Identifier
NCT01999673.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that future preclinical or clinical studies with bavituximab do not establish that PS is an adequate target to clear Ebola virus and infected cells, the risk that future preclinical studies or clinical studies with bavituximab do not circumvent the problem of virus escape mutations or show that PS plays a role in immunosuppression during Ebola infection. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2014 as well as any updates to these risk factors filed from time to time in the company's other filings with the Securities and Exchange Commission. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
1 S. Bhattacharyya et al. 2013. Enveloped viruses disable innate immune responses in dendritic cells by direct activation of tam receptors. Cell Host Microbe. 14, 136-147, doi:10.1016/j.chom.2013.07.005.
2 S. Jemielity et al. 2013. TIM-family proteins promote infection of multiple enveloped viruses through virion-associated phosphatidylserine. PLoS Pathog. 9:e1003232.
3 K. Morizono et al. 2014. Role of Phosphatidylserine Receptors in Enveloped Virus Infection. J. Virol. 88: 4275-4290.
4 S.K. Gire et al., 2014. Genomic surveillance elucidates Ebola virus origin and transmission during the 2014 outbreak. Science, doi: 10.1126/science.1259657.
5 Soares MM, King SW, Thorpe PE. Targeting inside-out phosphatidylserine as a therapeutic strategy for viral diseases. Nature Medicine 2008 Dec;14(12):1357-62.
6 Yi Yin, Xianming Huang, Kristi D. Lynn, and Philip E. Thorpe. Phosphatidylserine-Targeting Antibody Induces M1 Macrophage Polarization and Promotes Myeloid-Derived Suppressor Cell Differentiation. Cancer Immunology Research; 1(4); 256-68.
Contact:
Christopher Keenan
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
Ebola..
Ebola is a big deal!
SlideShow found August 2014 with PS and Peregrine
http://de.slideshare.net/PaulDRennert/rennert-immunotherapy-and-immunomodulatory-2014
search for: Brekken or Peregrine or bavituximab
http://www.nyas.org/Publications/Ebriefings/Detail.aspx?cid=356798bb-822e-4141-b196-317a8e1d2da7
Juli/August 2014 - search for : Bavituximab
http://www.landesbioscience.com/journals/mabs/2014MABSED0604-1.pdf
From March 2014/Credit Suisse - but i haven´t seen it before:
http://oncology.healthace.com/032114/oncology_report_032114.pdf
from Mach 2014 - page 21
http://surgonc.org/docs/default-source/pdf/sso_2014_abstracts_052714.pdf?sfvrsn=2
we are at 144
that´s no Problem for me - i sell nothing, i will buy more
i just want to share info i found - good and "bad" ones
new link with PPHM found:
http://cyto.blogs.sapo.pt/cel-sci-is-a-leader-in-the-i-o-class-of-24920
DOW lost 300 Points - quite low pphm-vol yesterday IMO
quite low vol. yesterday and today
And: i stand for two
I am one of them
I like that:
That means statistical significant from the start!!!