PPHM Pharma - Unternehmen mit Top-Meldung

http://www.peregrineinc.com/  

ASCO Research Foundation Grant Will Support Study of Peregrine's Bavituximab in Lung Cancer



- Career Development Award to Study Biology of Bavituximab and Chemotherapy in Lung Cancer Awarded to Dr. David Gerber of UT Southwestern Medical Center -


- New Study Complements Ongoing Bavituximab Plus Carboplatin/Paclitaxel Phase II NSCLC Trial that has Shown Promising Preliminary Results -


TUSTIN, Calif., June 10 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that the ASCO Research Foundation has awarded one of its 2009 Career Development Awards to David Gerber, MD, of the University of Texas Southwestern Medical Center for a study of the biologic effects of bavituximab and chemotherapy in patients with advanced lung cancer. Bavituximab is a monoclonal antibody with a unique mechanism that allows the body's own immune system to recognize and act on the tumor and its supporting blood vessels, resulting in anti-cancer effects.


This new study will supplement Peregrine's Phase II clinical trial evaluating bavituximab in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer (NSCLC). In the first cohort of this trial, 11 of 17 evaluable NSCLC patients, or 64.7%, achieved an objective tumor response according to response evaluation criteria in solid tumors (RECIST). Enrollment of an additional 28 NSCLC patients is ongoing.


"We are delighted that the ASCO Research Foundation has selected Dr. Gerber's study for this prestigious award that nicely complements our ongoing Phase II NSCLC trial, which has already shown very promising results," said Steven W. King, president and CEO of Peregrine. "This clinical study should help us to better understand the biological effects of this new class of immunotherapeutic agents and generate data that will help guide the future clinical development and use of bavituximab."


Dr. Gerber, assistant professor at the Harold C. Simmons Comprehensive Cancer Center of UT Southwestern, will receive a three-year award totaling $200,000 to support his original research, A Pilot Study of the Biologic Effects of Chemotherapy Plus Bavituximab in Patients with Advanced Non-Small Cell Lung Cancer. These competitive awards are available to promising physician researchers who are full-time faculty members in a clinical setting at an academic medical center.


Bavituximab is also currently being tested in combination with chemotherapy in two Phase II trials in advanced breast cancer. Preliminary positive results from one of these trials were the subject of an oral presentation at the 2009 ASCO Annual Meeting.


About Phosphatidylserine (PS)-Targeting Immunotherapies

The rapid and disorganized growth that is the hallmark of cancer results in the exposure of the lipid phosphatidylserine (PS) on the surface of tumor blood vessels. Since these phospholipids are typically not exposed on the surface of normal tissues, they represent a unique target for anti-cancer treatments. Bavituximab is a monoclonal antibody that binds specifically to these phospholipids exposed on the surface of the cells lining tumor blood vessels. Once bound, bavituximab alerts the body's immune system to attack the tumor blood vessels, inhibiting tumor growth and proliferation. In addition, a growing body of evidence supports the active role of PS in immune signaling, with recent research showing that exposed PS can have an immunosuppressive effect and dampen the body's normal response to cancer. By binding to and blocking PS, bavituximab is believed to boost the body's ability to combat cancer via this second immunostimulatory mechanism. Further information on the role of exposed PS in the tumor environment can be found in the Anti-PS Technical Backgrounder posted at www.peregrineinc.com.


About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing three separate clinical programs in cancer and hepatitis C virus infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside 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 rate of objective tumor response for the expansion stage of the Phase II trial will not be consistent with the objective tumor responses experienced in the first stage of the Phase II trial. 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 or otherwise adversely impact the company's ability to obtain regulatory approval for its product candidates 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 the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2008 and the quarterly report on Form 10-Q for the quarter ended January 31, 2009. 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.


   Contacts:
   GendeLLindheim BioCom Partners
   Investors                                 Media
   info@peregrineinc.com                     Barbara Lindheim
   (800) 987-8256                            (212) 918-4650



SOURCE Peregrine Pharmaceuticals, Inc.  

der Dollar ist geknackt.  

komme später wieder  

http://www.n-tv.de/panorama/Meldungen/...demie-aus-article349097.html  

Meldungen
Sonntag, 14. Juni 2009

Schweinegrippe
Erster Todesfall in Europa
Erstmals ist in Europa ein Patient an den Folgen der Schweinegrippe gestorben. Das bestätigte die schottische Regierung. In Deutschland stieg die Zahl der Infizierten auf 170. Ein erster bestätigter Fall in Berlin verlaufe mit schwachen Symptomen, hieß es.

In Europa gibt es den ersten Toten wegen der Schweinegrippe. Nach Angaben der schottischen Regierung ist ein Patient an dem Grippevirus H1N1 gestorben. Das teilte ein Regierungssprecher in Glasgow mit. Der Patient erlag nach den Angaben in einem Krankenhaus dem Virus. "Der Patient war grundlegend erkrankt", teilte der Sprecher mit. Er ist der erste Schweinegrippe-Tote außerhalb des amerikanischen Kontinents, wo die Grippeform zuerst aufgetreten war.

Neun weitere Menschen werden in Schottland in einer Klinik an dieser Grippeform behandelt, insgesamt sind derzeit 498 Menschen an Schweinegrippe erkrankt. In ganz Großbritannien sind es insgesamt mindestens 1250 Fälle. Die WHO hatte am Donnerstag die Schweinegrippe zur Pandemie erklärt. Seit Bekanntwerden der ersten Fälle in Mexiko infizierten sich weltweit fast 30.000 Menschen, mehr als 145 starben.

Erste Erkrankung in Berlin
In Deutschland sind nach Angaben des Robert-Koch-Instituts (RKI) derzeit 170 Erkrankungen bestätigt. Dazu zählt auch der erste Fall in Berlin: Es handele sich um eine 23-Jährige aus dem Berliner Bezirk Treptow-Köpenick, teilte die Gesundheitsverwaltung des Senats mit. Sie sei von einem eintägigen Aufenthalt in Düsseldorf zurückgekehrt. Sie weise keine schweren Symptome auf, hieß es.

Deshalb befinde sie sich auch nicht in der Klinik, sondern sei zusammen mit ihrem Lebensgefährten in der gemeinsamen Wohnung unter Quarantäne. Die Infektionsschutzbeauftragte Berlins, Marlen Suckau, riet der Bevölkerung zur Anschaffung eines Mundschutzes: "Jetzt ist ein guter Zeitpunkt, sich einen zu kaufen." Sie wies darauf hin, dass die Stadt auf eine mögliche Ausbreitung der Grippe gut vorbereitet sei.

In Düsseldorf stieg die Zahl registrierter Fälle derweil nach Angaben der Stadt auf 82. Unter den Neuinfizierten sind eine 24-Jährige, die aus New York zurückkehrte, und ein 29-Jähriger, der in Amsterdam war. In Brandenburg wurde die Erkrankung bei einem 33-Jährigen bestätigt, der von einer USA-Reise zurückgekehrt war. Auch in Niedersachsen wurde ein weiterer Fall registriert: Die Zehnjährige aus Hannover hatte sich bei ihrer Mutter angesteckt.

dpa  

Data Presented at Society of Nuclear Medicine 2009 Annual Meeting Supports Potential of Peregrine's Cotara(R) for the Treatment of Brain Cancer





- Dosimetry Study Results Show Greater Than 300-Fold More Radiation Delivered to Tumor as Compared to Other Normal Organs -


- All Patients in the First Two Cohorts Have Met or Exceeded the Expected Median Survival Time for Recurrent GBM Patients -


TORONTO and TUSTIN, Calif., June 16 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported that researchers will present data at the SNM 2009 Annual Meeting showing that its brain cancer agent Cotara(R) specifically localizes to brain tumors at high concentrations with minimal radiation exposure to other organs. Cotara is a targeted monoclonal antibody linked to a radioisotope being developed as a potential new treatment for glioblastoma multiforme (GBM), a deadly form of brain cancer. The results reported today from an ongoing dosimetry study at U.S. brain cancer centers show that in patients dosed in the first two cohorts of the study, the concentration of Cotara in brain tumors was on average more than 300-fold higher than in other normal organs. In addition, these patients have all either met or exceeded the expected median survival time of six months for recurrent GBM patients. Cotara is currently being tested in this Phase I dose response and dosimetry trial and in a Phase II clinical trial in recurrent GBM patients.


Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. In this study, lead author Sui Shen, Ph.D., associate professor of radiation oncology at the University of Alabama at Birmingham, and his colleagues assessed the concentration of Cotara in GBM patients' tumors and in their healthy brain tissue, as well as in their thyroid, stomach, heart and bone marrow. He found that Cotara was concentrated in the brain tumor with minimal exposure to the contralateral healthy brain. The thyroid, which can have active uptake of radioiodine, showed only minimal uptake of Cotara. Similarly, uptake of Cotara was very low in the stomach, heart and bone marrow, important potential sites for radiation toxicity. On average, the tumor received more than 300 times the dose of radiation compared to these normal organs.


"These findings confirming Cotara's potential to target its radioactive payload to brain tumors while minimizing radiation exposure to healthy organs, including the thyroid, are very encouraging," said Dr. Shen. "With a mean dose ratio showing 300-fold greater delivery of radiation to the tumor as compared to other organs, Cotara represents a potentially valuable new therapy for GBM patients."


The main objectives of the open label dosing and dosimetry study are to confirm the maximum tolerated dose of Cotara, to determine radiation dosimetry and to assess overall patient survival, progression free survival and the proportion of patients alive at six months following Cotara administration. In this study and in the ongoing Phase II trial, Cotara is delivered using convection-enhanced delivery (CED), a method developed by the U.S. National Institutes of Health that targets the specific tumor site in the brain. The final planned patient in the dosimetry study is currently being enrolled.


"These positive data analyzed by a leading dosimetry expert validate a key principle underlying the Cotara program, confirming its ability to specifically concentrate in and deliver a high radiation dose to brain tumors," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "In this trial and in our other Cotara clinical trials, Cotara has been well tolerated, and we continue to see longer- term survivors among the treated patients. We are very pleased to have the opportunity to share this promising data from our current U.S.

Cotara clinical trial with experts at this prestigious conference, and we look forward to reporting further data from this study and from our Phase II trial in patients with recurrent GBM."


More than 65 patients with recurrent GBM have received Cotara in the current and previous clinical studies. Localization and accumulation of the drug to the tumor have been excellent and longer-term survivors (greater than one year from the time of Cotara treatment) have been observed in all of the trials, with some GBM patients from early clinical studies now alive more than 8.5 years after treatment with Cotara. Expected survival for patients with GBM is approximately six months from the time of disease recurrence.


The Cotara data will be presented today at the 2009 Society for Nuclear Medicine (SNM) Annual Meeting in Toronto, Canada, in a session scheduled from 12:30 PM to 2:00 PM EDT in Room 701B.


Abstract No: 150240; Publication No: 445: S. Shen(1), R. Lustig(2), K. Judy(2), W. Shapiro(3), K. Spicer(4), S. Patel(4), J. Fiveash(1), J. Lai(5), J. Shan(5), "Dosimetry of phase I interstitial 131I-chTNT-1/B MAb (Cotara) for the treatment of recurrent glioma."


(1)U Alabama, Birmingham, AL; (2)U Penn, Philadelphia, PA; (3)BNI St. Joseph's MedCtr, Phoenix, AR; (4)Med U S Carolina, Charleston, SC; (5)Peregrine Pharma Inc, Tustin, CA


About Cotara(R)

Cotara is an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody designed to bind to the DNA histone complex that is exposed by dead and dying cells found at the center of solid tumors. Cotara's targeting mechanism enables it to bind to the dying tumor cells, delivering its radioactive payload to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue. In a previous clinical study, a subset of patients with recurrent glioblastoma treated with Cotara achieved a median survival of 38 weeks, a 58% increase over the historical median survival time of 24 weeks for patients treated with standard of care therapy. In this study, 25% of 28 recurrent patients survived for more than a year post-treatment and 10% of patients survived for more than three years. These data are considered a promising development in this deadly disease. Cotara has been granted orphan drug status and fast track designation for the treatment of glioblastoma multiforme and anaplastic astrocytoma by the U.S. Food and Drug Administration. A Phase I dosimetry trial in GBM patients in the U.S. is in the final stages of patient enrollment and a Phase II safety and efficacy trial in GBM patients in India is ongoing. For more information on the trials, visit www.clinicaltrials.gov.


About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing three separate clinical programs in cancer and hepatitis C virus infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside 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 dose-limiting toxicities may be experienced in future stages of the trial that will use higher doses of Cotara or the risk that results from larger trials may not be consistent with the results of earlier stage 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 the company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2008 and the quarterly report on Form 10-Q for the quarter ended January 31, 2009. 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.


   Contacts:
   GendeLLindheim BioCom Partners
   Investors                              Media
   info@peregrineinc.comBarbara Lindheim
   (800) 987-8256                         (212) 918-4650



SOURCE Peregrine Pharmaceuticals, Inc.  

http://news.prnewswire.com/.../story/09-02-2009/0005086855&EDATE=  

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42502816  

Peregrine Pharma's (PPHM) 1-for-5 Stock Split to Take Effect on 10/19

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that a previously approved reverse split of its common stock will take effect at the start of NASDAQ trading on Monday, October 19, 2009 on a 1-for-5 split-adjusted basis. Peregrine's shares will continue to trade on the NASDAQ Capital Market under the symbol "PPHM," with the letter "D" added to the end of the trading symbol for a period of 20 trading days to indicate the reverse stock split has occurred. The Company's symbol will revert back to its original symbol "PPHM" on November 16, 2009. A new CUSIP number will be assigned to Peregrine's common stock when the split becomes effective.  

Tustin, Kalifornien, 21. Oktober / PRNewswire / - Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHMD) gab heute positive Ergebnisse aus der Phase-II-Studie zur Evaluierung bavituximab in Kombination mit Docetaxel bei Patienten mit fortgeschrittenem Brustkrebs.


http://www.sunherald.com/prnewswire/story/1690404.html  

Wollte 13:30 Uhr welche für 0,38 Euro ordern... hat nicht geklappt! Naja, ich stehe bereit und hoffe, dass intrady das Gap geschlossen wird!

 

 

sell  

 

http://de.advfn.com/...ASDAQ:PPHM&p=0&t=24&dm=4&vol=1

 

http://www.ariva.de/...aceuticals-aktie/chart?t=year&boerse_id=40  

 

in de merkt es  

Peregrine Pharmaceuticals Announces Significant Progress in Advancing Its Cotara Program Into a Pivotal Phase III Trial / Agreement Reached With FDA on Pivotal Trial Design for Its Novel Targeted Therapy Cotara for the Treatment of Recurrent Brain Cancer
TUSTIN, CA -- (Marketwire) -- 12/05/12 -- Peregrine Pharmaceuticals (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced that it has made significant progress in advancing its Cotara program into late-stage development through its agreement with the U.S. Food and Drug Administration (FDA) on the design of a single registration trial for Cotara in patients with recurrent glioblastoma multiforme (GBM). The FDA has agreed with the company's proposed randomized trial design comparing two dose levels of Cotara in up to 300 patients. The trial design allows for multiple interim data analyses with the potential to stop patient accrual early based on predicted success or futility. Cotara has been granted orphan drug status and Fast Track designation for the treatment of GBM and anaplastic astrocytoma by the U.S. Food and Drug Administration (FDA) and orphan drug designation by the European Medicines Agency (EMA).

"We appreciate the input that the FDA has provided to us during the course of our discussions in order to arrive at this mutually agreed upon design, that, if successful, should be sufficient to support a full marketing submission," said Robert Garnick, Ph.D., Peregrine's head of regulatory affairs. "Our next steps include the engagement of other regulatory agencies, where we plan to run the trial as part of a global registration study."

Cotara is a targeted loco-regional therapy that delivers a high dose of radiation directly into the brain tumor while sparing radiation exposure to healthy brain tissue. Cotara is being studied as a one-time treatment that in previous clinical trials has shown promising overall survival in patients with recurrent GBM.

"Our goal going into these discussions with the FDA was to agree upon a clinical trial design that would be appropriate for this orphan indication and one which we could enroll within a two-year timeframe," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "Having achieved this goal, we are now beginning to plan for this global registration study while continuing partnering discussions."

"Having established a clear clinical path forward for this novel and targeted delivered drug candidate, we can now escalate our business development activities to secure a partnership, recognizing the great interest by companies in drug candidates within the orphan and rare disease space," said Steven W. King, president and chief executive officer of Peregrine. "Cotara and our lead oncology therapeutic candidate, bavituximab both represent significant opportunities. With key data from Phase II bavituximab clinical trials in several oncology indications set to read out in the coming months and the opportunity to advance Cotara into a pivotal trial, we have number of potentially significant value drivers on the horizon. We look forward to updating you further as we continue to make progress in our late stage clinical programs."

http://www.finanznachrichten.de/...agreement-reached-with-fda-256.htm  

Geht's weiter rauf oder wird erstmal der Gewinn mitgenommen?  

Zockmeute ist erst mal weg? das ist gut... kommt benötigte Ruhe rein

wäre schön, wenn sie dann mal wieder starten könnte...? schaunmamal...  

Events & Presentations

2013 ASCO Annual Meeting
May 31 - June 4, 2013
Location: McCormick Place, Chicago, IL

http://ir.peregrineinc.com/eventdetail.cfm?EventID=129371  

http://www.peregrineinc.com/images/stories/pipeline/pipeline_03-13.jpg