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Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity PPHM.O - MKW
10-Dec-2014 14:05
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Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity
State-of-the-Art Facility Design Using Modular Clean Rooms and Fully-Disposable Technologies Provide Flexibility to Meet Growing Production Demands; Facility Expected to Be Ready for cGMP Production in Mid-2015
TUSTIN, CA--(Marketwired - Dec 10, 2014) - Avid Bioservices, Inc, the contract manufacturing subsidiary of Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), today announced it has initiated an expansion of its biomanufacturing capacity. Avid provides high quality clinical and commercial manufacturing services under cGMP for the biotechnology and biopharmaceutical industries. The new production facility will more than double Avid Bioservices' current manufacturing capacity in a state-of-the-art facility design.
This facility will employ an innovative and flexible modular clean room design and the latest in single-use technologies that provide expanded capacity to meet the growing needs of Avid's existing and future clients. The capacity expansion will take place within an existing 40,000 square foot warehouse located adjacent to the company's current campus. The new cGMP facility will accommodate multiple single use bioreactors of up to 2,000 liters, downstream processing suites, and dedicated support utilities that will allow for the production of a variety of biological products.
"This new production suite will be a key component of our strategic growth as it allows us to meet the increasing demand for our clinical and commercial manufacturing," said Steven King, president at Avid. "As one of the early adopters of single-use technology, this expansion allows us to build upon our expertise in what is now a common mainstream practice for biologics production and is in line with our commitment to providing our clients with the highest quality service offerings to meet every phase of development and production."
"This will truly be a cutting edge facility utilizing a leading trend in biomanufacturing in terms of flexibility and efficiency," said Robert Garnick, Ph.D. head of regulatory affairs at Peregrine. "We have been pleased that the design, the flow, as well as equipment and timelines, have all been well received by leaders and experts in biomanufacturing. We look forward to having this facility build upon our exemplary inspection and audit record that Avid has achieved from multiple regulatory agencies."
About Avid Bioservices
Avid Bioservices provides a comprehensive range of high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 20 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, final product filling, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit www.avidbio.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 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 Avid Bioservices' 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 the new facility may not be ready for cGMP production during the summer of 2015 due to unanticipated delays in construction and/or validation, as well as receipt of any required regulatory approvals. Our business could be affected by a number of other factors, including the risk factors listed from time to time in Peregrine Pharmaceutical's 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. Avid Bioservices, Inc. and Peregrine Pharmaceuticals, Inc. disclaim any obligation, and do not undertake to update or revise any forward-looking statements in this press release.
Contact:
Christopher Keenan or Kelly Pisarev Lord
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
www.avidbio.com
© 2014 Marketwire L.P. All rights reserved.
nMKWZ6l4Qa
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Old???
BOARD C14
A phase II study of bavituximab and sorafenib in advanced hepatocellular carcinoma (HCC). (Abstract 345)
Presenting Author: Adam C. Yopp
http://gicasym.org/general-poster-session-b-and-trials-progress-poster-session-b-cancers-pancreas-small-bowel-and
Yes - but I would like to see (much)more vol.
I thought that was already on sunday?
Sorafenib
- Sorafenib Versus Placebo in Addition to Standard Therapy in Younger Patients with Newly Diagnosed Acute Myeloid Leukemia: Results from 267 Patients Treated in the Randomized Placebo-Controlled SAL-Soraml Trial
- Abstract #6, Session: Plenary Scientific Session, Oral Presentation
- Sunday, December 7, 2014: 3:45 PM, North Building, Hall D
I added some yesterday at $1,35 and hopped to get some today under 1,30 (no problem, i think i have enought....) but some more... let´s see----
Leverkusen, December 1, 2014 – Bayer HealthCare will present latest data from its hematology and oncology portfolio at the American Society of Hematology (ASH) 56th Annual Meeting, December 6-9, 2014, in San Francisco, CA. The presentations will describe the results from a Phase III study with octocog alfa (approved for hemophilia A under the trade name of Kogenate® FS (Kogenate ® Bayer in the EU)) as well as clinical and non-clinical results on damoctocog alfa pegol (BAY 94-9027) for hemophilia A therapy. Also, Phase II clinical trials results with sorafenib (approved for various indications relating to cancer of the liver, the kidney and the thyroid under the trade name Nexavar®) and copanlisib are presented for the treatment of different hematological cancers.
The presented data on Bayer’s products include two oral presentations. One presentation will discuss the three-year findings from the Phase III SPINART study for antihemophilic treatment with octocog alfa. The SPINART study evaluated the secondary propylaxis with octocog alfa on bleeding frequency and joint damage compared to episodic treatment in adults with severe hemophilia A. The other oral presentation will show the results of an independent investigator-sponsored randomized study of Dresden University and the Studienallianz Leukämie (SAL) with sorafenib in combination with standard chemotherapy for the treatment of acute myeloid leukemia.
I hoped to add some unter $ 1,30 today.
Found that link:
http://imedex.com/
with that one:
http://www.imedex.com/anti-angiogenesis-and-immune-therapies/
and that name:
Lee M. Ellis, MD
The University of Texas
MD Anderson Cancer Center
Houston, Texas
Evotec and Sanofi Enter Into Exclusive Negotiations for a Major Multi-Component Strategic Collaboration
02-Dec-2014 18:42
• Parties have entered into exclusive negotiations and expect to sign the transaction in H1 2015
• Goal to improve innovation effectiveness in drug discovery and pre-clinical development
• Building pipeline focused on oncology
• Innovation bridge from academia to Pharma
• Long-term outsourcing collaboration on key drug discovery services for Sanofi; Evotec will acquire Sanofi's scientific operations in Toulouse
• Creation of Evotec's European compound management facility and service
• Pioneering open innovation programme with Sanofi and Evotec offering their combined approx. 1.7 million small molecule libraries to biotech and other Pharma players * € 250 m minimum guaranteed commitment from Sanofi to Evotec over the next five years, including a sizeable upfront cash payment that will be defined in the agreement
HAMBURG, Germany, Dec. 2, 2014 (GLOBE NEWSWIRE) -- Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) announced today that it has entered into exclusive negotiations with Sanofi on a major multi-component strategic alliance over the next five years.
The collaboration will comprise three major strategic initiatives all focused on improving innovation effectiveness in the drug discovery and pre-clinical development space and cement Evotec's position as the leading drug discovery collaboration partner to the Pharma and biotech industry as well as academia.
The collaboration will result in a minimum guaranteed commitment from Sanofi to Evotec of € 250 m over the next five years, including a sizeable upfront cash payment that will be defined in the agreement. It will include a co-development agreement with associated upfront, development, regulatory and sales milestones as well as royalties benefiting both parties. This multi-component transaction is expected to be signed in the first half of 2015, subject to finalization of definitive agreements and completion of the appropriate social process.
Dr Werner Lanthaler, Chief Executive Officer of Evotec, said: "We are very proud that Sanofi has chosen Evotec for this significant alliance. This collaboration is a major milestone in the drug discovery space and accelerates Evotec's strategy to become the leading drug discovery partner to the Pharma and biotech industry as well as academia. We will warmly welcome the Sanofi employees to the Evotec Group and look forward to working with them."
"Open innovation is a key driver of Sanofi's strategy. We believe Evotec will be an ideal partner, a company that fits our quality expectations and our strategic vision. Our collaboration will secure the future for our employees in Toulouse and importantly accelerate our pipeline productivity," said Dr Elias Zerhouni, President Global R&D for Sanofi.
The alliance, upon completion, will cover three major strategic initiatives:
1. Pipeline-building collaboration with initial focus on oncology
Under the agreement, both partners will collaborate on selected pre-clinical development projects with a focus on oncology and potential Cure X/Target X initiatives.
Evotec will typically accelerate drug discovery projects to the point of pre-clinical development candidates ("PDC") from which point Sanofi may take over the development and commercialisation. Evotec will license from Sanofi a portfolio of projects including five well-advanced pre-clinical projects in oncology that will be progressed to IND ("Investigational new drug") jointly by Sanofi and Evotec before potential partnering.
French academic bridge programme
Evotec will continue to expand its Cure X/Target X business model to leverage scientific expertise and a broad portfolio of drug development services to capitalise on the most promising science from French and European academia. Sanofi will fund this initiative through a commitment to Evotec's scouting strategy over the period of the agreements. Sanofi could provide support to individual projects that will be progressed through this academic bridge programme.
2. Outsourcing alliance including acquisition of Sanofi's drug discovery operations in Toulouse to build an European centre of excellence for compound management and drug discovery services
In order to meet its strategic capacity needs, Evotec will expand its industry-leading capabilities in integrated drug discovery of currently approx. 650 scientists by integrating a state-of-the-art scientific and technological facility which has more than 200 highly qualified and experienced scientists from the Sanofi research site in Toulouse, France. Evotec will integrate the Toulouse capacities, which is a highly productive small molecule discovery site, into its global drug discovery platform. The expanded capabilities will cover the early-stage discovery and pre-clinical process from screening to medicinal chemistry. From this new facility, Evotec will perform collaborative research with its Pharma, biotech and academic partners as well as its own internal oncology research.
Strategic service agreement in compound management
Evotec will assume management of Sanofi's global screening compound library as well as provide a broad range of drug discovery services for Sanofi for the period of the contracts.
By thus increasing capability in compound management services, Evotec will cement its position as the world leader in outsourced compound management.
3. Pioneering open innovation by offering combined libraries
In a ground-breaking initiative within the industry, Sanofi and Evotec plan to combine their libraries to make them available for screening to Evotec's partners. The Sanofi library, established on its Toulouse site with over 1,000,000 compounds, will expand Evotec's own corporate library of more than 400,000 compounds, thus creating a very large and valuable source of starting points for drug discovery. Evotec will screen the libraries against collaborators' and partners' targets under pre-agreed terms from which Sanofi will receive a contribution if a product is developed from a library hit. This initiative further consolidates Evotec's position as the leading provider of screening services in the industry.
Evotec invites you to join a conference call to provide information regarding this major alliance with Sanofi. The conference will be held in English.
Webcast/Conference Call
Conference call details
Date: Wednesday, 03 December 2014
Time: 9.30 am CET (08.30 am GMT, 3.30 am EST)
From Germany: +49 (0) 69 2017 44 210
From UK: +44 20 7153 9154
From USA: +1 877 423 0830
Access Code: 129176#
A simultaneous slide presentation for participants dialling in via phone is available at http://www.audio-webcast.com/
http://www.globenewswire.com/newsroom/ctr... password: evotec1214.
This Martin Reck is talking at CELCC in Vienna
http://www.events.mondial.at/ei/2014/Downloads/CELCC/CELCC2014_FinalProgramme.pdf
Page 18
Just an Info - CELCC 2014 in Vienna ( Not Christmas in Vienna )
http://www.mondial-congress.com/de/celcc2014#Industry
NSCLC on monday.
ESMO 2014 News
http://www.esmo.org/Oncology-News?hit=ehp
But no news from day 2 (22. Nov.) until now.
Molecular Biology Meets Finance: MLV's George Zavoico On Ebola's Silver Lining
PPHM mentioned:
http://www.barchart.com/headlines/story/3585908/molecular-biology-meets-finance-mlv-s-george-zavoico-on-ebola-s-silver-lining
TLSR: Could we look at another name, please?
GZ: The developing story about Peregrine Pharmaceuticals Inc. (NASDAQ:PPHM) is the emerging recognition that bavituximab, its lead compound, a monoclonal antibody, is indeed an immune checkpoint inhibitor.
As you know, tumor immuno-oncology and checkpoint inhibitors are the Holy Grail in cancer research right now. If you can get the immune system to recognize cancer and enable T cells to eliminate it, then you can get remarkable results, like we've seen with some of the antibodies targeting PD-1 [programmed cell death protein-1] and CTLA-4 [cytotoxic T-lymphocyte-associated protein 4]. Bavituximab is upstream of those-at the very beginning of the cascade.
Peregrine is investigating combinations with some of the more established checkpoint inhibitors. As interesting as these targets-PD-1 and CLTA-4-have been, they are effective by themselves in up to 40% or so of patients, depending on the cancer. There are multiple pathways through which T cells are inhibited and stimulated to recognize a tumor. Some of these immunotherapy combinations could be toxic, and might even tip a patient over into an autoimmune disease, so researchers have to be very careful with the combinations they choose.
Bavituximab is in a Phase 3 trial in NSCLC. Hopefully that will play out positively for Peregrine and put the therapy on the map. Bavituximab has a bit of a checkered history, including problems in the Phase 2 trial, when the contract research organization [CRO] running the Phase 2 trial messed up. Certainly there are risks here, but investors are seeing a higher level of risk than is justified, because bavituximab, even correcting for the mishap with the CRO, has pretty good data in prolonging both progression-free and overall survival.
TLSR: On Oct. 15, Peregrine put out a press release saying it had peer-reviewed data to show that phosphatidylserine, the lipid being targeted by bavituximab, could be of value as a target in Ebola virus disease. Is the company looking for some BARDA funding or other federal money to move that along?
GZ: Peregrine has had an antiviral program for some time, but it has been dormant because the company has focused its resources on the cancer indications.
But you're right, virally infected cells express phosphatidylserine on their surfaces. When enveloped viruses like Ebola bud off the mammalian cells they infect, they carry some of that membrane with them. That means the phosphatidylserine remains on the surface of the virus. So bavituximab potentially could be effective in not only identifying infected cells, but also in identifying the virus. The Peregrine investigators have found that bavituximab by itself is not as effective as it would be in combination with antivirals, and we know from experience that the best results with antiviral therapy requires a cocktail of two or more drugs. If bavituximab can be used to enhance the efficacy of an existing cocktail, that would be an important finding for Peregrine.
Old? or... is this form November or from June?
http://www.biospace.com/clinicaspacejobs/job-listing/director-sr-director-clinical-research-336190
Thx for Info - i wait for April 2015 it´s a very good month - my bithday
Realy? But D. Carbone is there!
https://www.webges.com/cslide/library/esmo/browse/itinerary/536/2014-11-22#afc
ESMO in Geneva starts today
IPO was 1980 at $ 35
1990 stock was at $ 9 before Roche bought 56 %! Than $ 18 !!!
2009 stock was at $ 90
October 14, 1980
Initial Public Offering (IPO)
1,000,000 shares offered at $35.00
Genentech stock trades on NASDAQ under symbol GENE
March 30, 1983
Payable date of 3-for-2 stock split
March 15, 1985
Follow-on Public Offering
1,000,000 shares offered at $45.00
February 28, 1986
Payable date of 2-for-1 stock split
February 27, 1987
Payable date of 2-for-1 stock split
March 2, 1988
Genentech stock begins trading on the NYSE under the symbol GNE
September 7, 1990
Genentech and Roche Merger approved by stockholders
Each share of Genentech Common Stock (CUSIP 368 710 109) is exchanged for $18 in cash plus one-half share of Genentech Redeemable Common Stock (CUSIP 368 710 208)
October 25, 1995
Genentech stockholders approve Roche's extended buyout option
Each share of Genentech Redeemable Common Stock (CUSIP 368 710 208) is exchanged for one share of Genentech Callable Putable Common Stock (also known as Genentech Special Common Stock - CUSIP 368 710 307)
June 14, 1999
Roche exercises its Call Option for all outstanding shares of Genentech Special Common Stock - redemption date set for June 30, 1999
June 16, 1999
Last day of trading of Genentech Special Common Stock
June 30, 1999
Genentech redeems its Special Common Stock
Each share of Genentech Special Common Stock (CUSIP 368 710 307) is exchanged for $82.50 in cash (except for those shares held by Roche)
July 19, 1999
Roche sells shares of Genentech Common Stock in a Public Offering
22,000,000 shares offered at $97.00
Genentech stock begins trading on NYSE on July 20, 1999 under the symbol DNA (CUSIP 368 710 406).
October 20, 1999
Roche sells shares of Genentech Common Stock in a Public Offering
20,000,000 shares offered at $143.50; shares begin trading on NYSE on October 21, 1999.
November 2, 1999
Payable date of 2-for-1 stock split
March 23, 2000
Roche sells shares of Genentech Common Stock in a Public Offering
17,300,000 shares offered at $167.25; shares begin trading on NYSE on March 24, 2000.
October 24, 2000
Payable date of 2-for-1 stock split
May 12, 2004
Payable date of 2-for-1 stock split
March 26, 2009
Roche acquires all of Genentech Common Stock (CUSIP 368 710 406) at $95 per share. Last day of trading of Genentech Common Stock.
Roch payed $95 in 2009 for the rest of 44 % Genentech. In 1990 they bought 56 % of Genentech.
Peregrine works in Russia together with:
http://www.sentrytechnology.com/
In Russia they have OR looking for 54 patients (it´s not clear for me!):
http://mospharma.org/imgs/solo2-14full.pdf
seach for pphm 1202 and use Google Transl.
Found two in France:
http://www.pole-cancerologie-bretagne.fr/annuaire-des-essais-cliniques.html?trial=457
Brest - CHU de Brest - Site Morvan Dr G. Robinet - Jacquemine Menard - jacquemine.menard@chu-brest.fr / Oui 23/06/2014
Rennes - CHU de Rennes - Site Hôpital Pontchaillou - ARCs/IRCs Pneumologie - ide-pneumo-arc@chu-rennes.fr 1 / 6 Oui 07/11/2014
i can translate it to you, because i´m from Austria (we speak german here)
but not on friday!
5 months? - thats nothing for me, i can wait even longer
ELCC 2015 European Lung Cancer Conference - 15. - 18. April
David Carbone is there.
http://www.esmo.org/Conferences/ELCC-2015-Lung-Cancer
Eastern Capital
4.41% 7.92m shares +0.50m shares
Latest Filing Date 13-Feb-2013 Turnover: Low
.....Peregrine is actively working to further explore the potential of bavituximab in this and other indications as we look forward to the presentation of full clinical outcome data from this Phase II clinical trial by its lead investigator, Adam Yopp, M.D., assistant professor of surgery at the University of Texas Southwestern Medical Center in Dallas, Texas at a future medical conference.
PRESS RELEASE - PHASE II CLINICAL DATA PRESENTED AT SITC ANNUAL MEETING SUPPORT IMMUNOTHERAPEUTIC MECHANISM OF ACTION OF PEREGRINE PHARMACEUTICALS' BAVITUXIMAB IN LIVER CANCER PPHM.O -
10-Nov-2014 13:30
Phase II Clinical Data Presented at SITC Annual Meeting Support Immunotherapeutic Mechanism of Action of Peregrine Pharmaceuticals' Bavituximab in Liver Cancer PPHM.O - MKW
10-Nov-2014 13:30
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Phase II Clinical Data Presented at SITC Annual Meeting Support Immunotherapeutic Mechanism of Action of Peregrine Pharmaceuticals' Bavituximab in Liver Cancer
Combination of Bavituximab and Sorafenib in Patients With Advanced Liver Cancer Resulted in Increased Cytotoxic T-cell Activation and Other Immune Responses Within Tumors Which Positively Correlated With Patient Outcome; Additional Presentations Demonstrate Bavituximab Combined With Anti-CTLA-4 Treatments Increased Tumor-Fighting Immune Cells and Reduced Immune-Suppression Resulting in Statistically Significant Anti-Tumor Activity in Preclinical Models of Breast Cancer and Melanoma
TUSTIN, CA--(Marketwired - Nov 10, 2014) - Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), today announced the presentation of clinical and preclinical data related to the company's immuno-oncology development program and its lead investigational immunotherapy drug candidate bavituximab at the Society for Immunotherapy of Cancer's (SITC) 29th Annual Meeting and Associated Programs. This conference was held November 6-9, 2014 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland. The translational clinical presentation titled: "Correlative Studies of a Phase II Clinical Study of Bavituximab and Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)" was presented Saturday.
"The correlative studies from these liver cancer patients provide further support for the hypothesis that bavituximab can positively regulate immune cells in tumors and thus may provide a new and exciting possibility for therapeutic manipulation of the tumor microenvironment," said Dimitry I. Gabrilovich, M.D., Ph.D., a collaborator on the studies and a Christopher M. Davis Professor in Cancer Research and Program Leader, Translational Tumor Immunology at The Wistar Institute in Philadelphia, Pennsylvania.
Data from this translational sub-study consisting of six patients show that half of the patients evaluated had an increase in tumor fighting immune cells following one cycle of treatment, similar to what has been shown for PS-targeting antibodies in multiple preclinical cancer models. In addition, the increase in immune response was associated with patients that remained on study treatment for longer time periods, suggesting the possibility of a clinically meaningful anti-tumor immune response. Three of the six patients evaluated had increased infiltration of CD8 T-cells into the tumor microenvironment which correlated with a prolonged time to disease progression. In addition, these responding patients expressed lower levels of PD-1, an established marker of T cell activation and disease outcome, prior to the initiation of therapy, followed by a measurable rise.
"These translational data align very well with previous preclinical data that define bavituximab's immunotherapy-based mechanism of action and show that the combination of bavituximab and sorafenib can potentiate an anti-tumor response in patients with advanced HCC," said Nikoletta Lea Kallinteris, M.Sc., CCRP, senior scientist, translational research at Peregrine Pharmaceuticals. "Another interesting observation is that the increase in PD-1 positive T-cells observed in several patients from this trial provides rationale for the potential of bavituximab to increase the number of subjects who may respond to PD-1 targeted treatments.
Peregrine is actively working to further explore the potential of bavituximab in this and other indications as we look forward to the presentation of full clinical outcome data from this Phase II clinical trial by its lead investigator, Adam Yopp, M.D., assistant professor of surgery at the University of Texas Southwestern Medical Center in Dallas, Texas at a future medical conference.
More information on this trial can be found at www.ClinicalTrials.gov using Identifier NCT01264705.
In addition to this translational clinical data, two additional preclinical data presentations were made at the Saturday poster session of the SITC annual meeting. A poster titled, "Antibody-mediated Blockade of Phosphatidylserine (PS) Enhances the Anti-tumor Activity of Immune Checkpoint Inhibitor anti-PD-1 by Affecting Myeloid Derived Suppressor Cells (MDSC) and Lymphocyte Populations in a Breast Tumor Microenvironment" was presented by Bruce Freimark, Ph.D., director, preclinical research, oncology at Peregrine Pharmaceuticals. Data show that the combination of the phosphatidylserine (PS)-targeting antibody ch1N11, the preclinical equivalent to bavituximab, and an anti-PD-1 antibody demonstrated statistically significant (p=0.036) tumor growth inhibition in mice bearing EMT-6 breast tumors compared to anti-PD-1 alone. Further, researchers using fluorescence-activated cell sorting (FACS) found that T cell infiltration of the tumor was significantly increased in tumors of mice treated with the combination of ch1N11 and anti-PD-1 compared to single agent treatments alone. Lastly, data show that the combination treatment resulted in a significant reduction in MDSCs, whose presence plays a dominant role in suppressing the immune system associated with tumor progression in animal models.
The second pre-clinical presentation titled, "Antibody-mediated Blockade of Phosphatidylserine Enhances the Anti-tumor Activity of Immune Checkpoint Inhibitor anti-PD-1 by Affecting Myeloid Derived Suppressor Cells (MDSC) and Lymphocyte Populations in a Melanoma Tumor Microenvironment" was presented by Xianming Huang, Ph.D., assistant professor, Hamon Center for Therapeutic Oncology, Pharmacology, Simmons Comprehensive Cancer Center University of Texas Southwestern Medical Center, Dallas, Texas. Dr. Huang reviewed data showing that the PS-targeting antibody ch1N11, the preclinical equivalent to bavituximab, significantly enhances tumor growth inhibition of anti-PD-1 in the B16 model of melanoma as well as showing the suppression of outgrowth of tumors resistant to anti-PD-1 therapy. Researchers also show that the combination of ch1N11 and anti-PD-1 produced significantly greater T cell infiltration in both tumor models compared to single agents as well as an increased percentage of splenic T cells producing IL-2 and IFNg, factors associated with immune activation, in the K1735 tumor model. Data further show a significant reduction in MDSCs in the combination group when compared to single agents alone. Lastly, the combination of ch1N11 and an anti-PD-1 produced significantly decreased levels of M2 immunosuppressive macrophages in tumors of K1735 bearing animals compared to control treated animals.
The link to all of these posters 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 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 the translational data obtained from future clinical studies may not correlate with the data from these studies and the risk that increase in immune response for the three noted patients does not lead to a clinically meaningful anti-tumor immune response. 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.
Contact:
Christopher Keenan
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
© 2014 Marketwire L.P. All rights reserved.
Pphm - the same pocedure as every day
low vol. signalizes - no news coming today (imo)
We are taking about FISCALYEAR???!!! OR: early next year???
still 125k at 1,60 bid
BUT: little strokes fell big oaks
128.900 at 1,60$ ask
from 1,50 to 50$ = profit 3233%
from 2,50 to 50$ = profit 1900%
What a difference
thank you for that information!