PPHM - Sector: Healthcare - Industry: Biotechnology & Drugs

[rdemp52572]

You gotta love this PR because big pharma is on the prowl and things like this will catch a few eyes:

"...Total revenues for the current quarter increased 286% to $1,625,000 versus $421,000 for the comparable quarter last year. Avid Bioservices, the company's wholly-owned contract manufacturing subsidiary, contributed $1,621,000 in contract manufacturing revenue versus $398,000 recorded in the similar prior year period..."

We're looking mighty cheap here with all this good news lately and should see a POP soon!

[boatguy]

Picked up some more

Peregrine Pharmaceuticals May Be On To Something-Seeking Alpha

http://seekingalpha.com/article/47860-peregrine-pharmaceuticals-may-be-on-to-something?source=yahoo

[boatguy]

Breakout

News

- Immunocytokine Combining Peregrine's Anti-PS Antibodies and IL-2 Protected 80% of Animals From a Lethal Challenge With a Highly Aggressive Form of Cancer

http://biz.yahoo.com/prnews/071005/laf038a.html?.v=1

[setravis]

ANNOUNCES FIRST PATIENT DOSED IN TRIAL: Peregrine Pharmaceuticals (PPHM) announced
that the first patient has been dosed in a clinical trial designed to evaluate the safety
and pharmacokinetics of bavituximab in patients co-infected with HCV and the human immunodeficiency
virus (HIV). This open-label, dose escalation study will be conducted in approximately
24 patients chronically infected with HCV and HIV.

[stock-kitty]

I am with you guys on this one also. GLTA


Cheers

[boatguy]

Well I was wrong on this one

I let my gain turn into a loss and bailed at .59.

Still watching though and just saw that someone has some hilarious vids on youtube.

Enjoy!

http://www.youtube.com/watch?v=-Dw2iH79IGg&feature=user

http://www.youtube.com/watch?v=xeSfmjjWaMA

[setravis]

Press Release Source: Peregrine Pharmaceuticals, Inc.


Peregrine Pharmaceuticals' Bavituximab Achieves Primary Endpoint in First Stage of Phase II Lung Cancer Study
Wednesday February 4, 8:00 am ET


-Preliminary Data Show Seven of 17 Evaluable Patients Achieved an Objective Tumor Response by End of Four Treatment Cycles-
TUSTIN, Calif., Feb. 4 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM - News) today reported that its lead product candidate bavituximab achieved the primary efficacy endpoint in the first stage of its ongoing Phase II clinical trial in patients with non-small cell lung cancer (NSCLC). The open-label, Simon two-stage study is designed to evaluate the safety and efficacy of the combination of bavituximab with the chemotherapy drugs carboplatin and paclitaxel in NSCLC patients. Seventeen of the 21 patients enrolled in Stage A were deemed evaluable for tumor response by the end of four treatment cycles, with six patients achieving partial tumor responses and one patient achieving a complete tumor response, according to RECIST criteria. These preliminary results exceed the pre-specified benchmark criteria established for enrolling an additional 28 patients in Stage B of this trial, up to a total of 49 patients.


"We are very pleased with the promising early results from this pilot Phase II lung cancer trial and will now move forward to initiate the second stage of the study," said Steven W. King, president and CEO of Peregrine. "We are encouraged by the number of tumor responses seen at this early time point of approximately 12 weeks in patients with NSCLC, a leading cause of cancer deaths that responds poorly to current treatments. As these patients continue on treatment, we will be assessing them for further signs of anti-tumor activity, and we look forward to sharing more data from this study as patient treatment and follow-up progress."

The primary objective of the multi-center Phase II clinical trial in patients with previously untreated locally advanced or metastatic NSCLC is to assess the overall tumor response rate. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters. All tumor responses in the trial are being evaluated using RECIST criteria. Patients may continue to receive bavituximab alone after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. The trial is being conducted in India according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.

Lung cancer is a major cause of cancer deaths worldwide. According to the American Cancer Society, in the U.S. lung cancer is the second most commonly diagnosed cancer in men and women and is the leading cause of cancer deaths. It estimates that in the U.S. in 2008, there were approximately 215,020 new cases of lung cancer and an estimated 161,840 lung cancer deaths. NSCLC is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases.

Bavituximab is a monoclonal antibody that binds to the cellular membrane component phosphatidylserine (PS) that is usually located inside cells, but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. By binding to PS, bavituximab is believed to help mobilize the body's immune system to destroy the tumor and the tumor blood vessels. Bavituximab currently is in two separate Phase II combination therapy trials for the treatment of advanced breast cancer and a Phase II combination therapy trial for the treatment of non-small cell lung cancer. A Phase I bavituximab monotherapy trial in advanced solid cancers is also continuing.

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and bio-manufacturing 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 company will experience delays or difficulties in enrolling patients in the study, the risk that the standard carboplatin and paclitaxel response rate will not be improved as a result of the combination therapy and the risk that the results of the subsequent stage for this trial will not be consistent with the results of the first stage. 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 October 31, 2008. 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
    [email protected]              Barbara Lindheim
    (800) 987-8256                     (212) 918-4650




--------------------------------------------------------------------------------
Source: Peregrine Pharmaceuticals, Inc.

[setravis]

updated chart look...

[setravis]

Press Release Source: Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals Reports Progress in Cotara(R) Brain Cancer Clinical Program
On Thursday May 28, 2009, 7:59 am EDT

Data from Ongoing Glioblastoma Dosimetry Trial Accepted for Oral Presentation at 2009 Society of Nuclear Medicine Annual Meeting --

--Over 65 Recurrent GBM Patients in Phase I and Phase II Clinical Trials Have Received Cotara to Date, with a Good Safety Profile and Longer-Term Survivors Seen in All Studies--

TUSTIN, Calif., May 28 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and serious virus infections, today provided an update on progress in the company's clinical program for Cotara®, a targeted monoclonal antibody-based therapy being tested in a Phase II trial as a potential new treatment for recurrent glioblastoma multiforme (GBM), a deadly form of brain cancer. The company also reported that patient enrollment in the final cohort of a second Cotara GBM trial, a dose confirmation and dosimetry study, is nearing completion and that interim data from this trial has been accepted for an oral presentation at the Society of Nuclear Medicine Annual Meeting to be held June 13-18, 2009.

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 time of disease recurrence.

In the ongoing Phase II safety and efficacy trial, over half of the 40 planned GBM patients have been dosed with Cotara and patient follow-up is continuing. Screening for the anticipated final patient in the dose confirmation and dosimetry trial is underway and patient follow-up in that trial also is continuing. Data from this trial continues to support the superior targeting properties of Cotara and the resulting accumulation of high doses of radiation specifically in the tumor.

"We are encouraged at the continuing progress in the Cotara clinical program, with screening for the anticipated final patient in the dosing and dosimetry trial now underway, more than half of the planned GBM patients enrolled in the Phase II trial, and acceptance of our oral presentation at the upcoming Society of Nuclear Medicine Annual Meeting," said Steven W. King, president and CEO of Peregrine. "Patients have tolerated the Cotara regimen well and we continue to see longer-term survivors among the treated patients, consistent with our experience in previous Cotara clinical studies."

Overall, Cotara has been administered to a total of more than 115 patients with brain, colon or liver cancer. Promising data from these studies support Cotara's ability to specifically target solid tumors and its anti-tumor activity, as well as its acceptable safety profile.

Mr. King added, "We continue to actively explore partnering opportunities and options for expanding the accessibility of Cotara to GBM patients in the U.S. and other territories, to ensure continued development of this drug candidate that we believe may offer a positive treatment option for patients with this devastating disease."

The primary objective of the open label, multi-center Phase II trial is to confirm the maximum tolerated dose of Cotara in GBM patients at first relapse. Secondary objectives include estimates of overall patient survival, progression free survival and the proportion of patients alive at six months. Patients in the trial are receiving a single infusion of Cotara by convection-enhanced delivery (CED), a technique that delivers the agent to the tumor with great precision. Brain scans are administered at eight-week intervals post-treatment. Cotara has been generally well tolerated with an acceptable safety profile in clinical studies completed to date.

The main objectives of the open label Phase I dosing and dosimetry study at U.S. brain cancer centers are to confirm the maximum tolerated dose, 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. Dosimetry data presented at the 2008 ASCO Annual Meeting showed that Cotara delivered 100-fold more radiation to the tumor as compared to other organs. Expanded data from this study has been accepted for an oral presentation at the Society of Nuclear Medicine Annual Meeting on June 16, 2009 in Toronto, Canada.

Cotara Presentation Details:

Reference #: 150240

Publication No.: 445

Abstract Title: Dosimetry of phase I interstitial 131I-chTNT-1/B MAb (Cotara) for the treatment of recurrent glioma

Accepted to: ISRTRD Integrated Session (Oral)

Session Info: Dosimetry/Radiobiology IV: Targeted, Diagnostic and Therapeutic Agents

Tuesday, June 16

12:30 PM - 2:00 PM

Room 701B

About Cotara®

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. Cotara is delivered using convection-enhanced delivery (CED), an NIH-developed method that targets the specific tumor site in the brain. 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. has completed 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 product candidates in clinical trials for the treatment of cancer and serious virus infections. The company is pursuing three separate clinical programs in cancer and hepatitis C virus (HCV) infection with its lead product candidates bavituximab and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com/), which provides development and bio-manufacturing 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 company will experience delays or difficulties in enrolling patients in the study and the risk that the survival results from future trials will not be consistent with historical survival results. 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
    [email protected]                        Barbara Lindheim
    (800) 987-8256                              (212) 918-4650

[setravis]

Small Caps Wave Systems, Biodel: Small-Cap Winners
01/13/11 - 12:37 PM EST

NEW YORK (TheStreet) -- Shares of biotech company Biodel(BIOD) were topping the small-cap space on Thursday, jumping 27% to $2.49.
Biodel, a development stage biopharmaceutical company is focused on the diabetes market. The company will be presenting an update at the J.P.Morgan Heatlhcare Conference at 9:30 a.m PST. The update will include information about the development of new follow-on formulations of its lead product, Linjeta including milestones and timelines, according to its press release.
Nearly 5 million shares were changing hands on Thursday afternoon against an average trading volume of 900,000.

Wave Systems(WAVX) was also riding on heavy volumes, soaring 14% to $5.03. Over 4 million shares were changing hands on Thursday. The Obama Administration is working on a cybersecurity ID program that would allow users to log onto different sites without having to remember different passwords for each one. That has led to a pop in the shares of Wave Systems, which offers software that enables hardware encryption and the ability to do away with multiple passwords

Canada'sEXFO (EXFO) which provides services for the telecommunications industry, was soaring after it reported higher-than-expected profits .
The company earned $14.1 million, or 23 cents a share, for the three months ended Nov. 30 with total sales rising almost 50% year-over-year to $67.6 million. EXFO's outlook called for
earnings of 17 to 21 cents a share and sales ranging from $61 million to $66 million. Earnings growth was helped by the sale of the Life Sciences and Industrial Division for $23 million in cash.
EXFO forecast earnings of 3 to 7 cents a share and sales of between $70 million and $75 million. Shares were gaining 21% to $9.14 on volume of over 2 million on Thursday's trading, much higher than its average trading volume of 28,000.

Other stocks rising on higher volumes include TTM Technologies(TTMI), Peregrine Pharmaceuticals(PPHM) and China Media Express(CCME).


Among the losers, SemiLEDS(LEDS) was shedding about a third of its value Thursday after it issued a weak revenue outlook for the next quarter. The LED market player went public in December and has risen 25% since its IPO.
Shares of Canadian communications equipment maker DragonWave (DRWI) tumbled 16% to $8.75 after it reported a loss for the latest quarter and forecast a steeper sequential drop on the topline.
 

[setravis]

Trial News Make Peregrine Pharmaceuticals Worth Watching...

Day's Range: 2.73 - 3.09
52wk Range: 1.25 - 4.30
Volume: 2,580,748
Avg Vol (3m): 779,128
Market Cap: 190.52M
P/E (ttm): N/A
EPS (ttm): -0.46
Div & Yield: N/A (N/A)

Technicals
Percentage Gainer

Last Price Quote is:
20.45%above 13-day EMA
48.25%above 50-day EMA
RS Rating: 97 

[setravis]

Trial News Make Peregrine Pharmaceuticals Worth Watchingat Seeking Alpha(Tue, Jan 11)

Recently, Peregrine Pharmaceuticals, Inc. (PPHM) announced that it has initiated several trials in oncology and viral infections. They seem poised to garner attention from the Street over the coming months.

Yesterday, we just got news they started another trial, this one is a Phase II clinical trial in patients with previously untreated genotype-1 hepatitis C virus (HCV) infection. Just days earlier, PPHM announced that it has initiated a randomized Phase 2 trial in patients with previously untreated stage IV pancreatic cancer. This is the second trial that PPHM has started since December, the other being a Phase I/II in advanced liver cancer. We like their approach and diversification. We believe this could be a top stock to follow in 2011.

Bavituximab is an extremely interesting molecule which has created a lot of buzz over the past two years; not just in oncology but also as a potent anti-viral. As PPHM's novel anti-phosphatidylserine (anti-PS) antibody candidate, bavituximab has shown considerable promise in preclinical animal models showing it can cure lethal virus infections. It is a broad-spectrum drug, which means it could potentially be used to treat many different viruses. This is because it improves the cell's defense against all viruses rather than attacking a specific type of virus directly.

Today's trial news builds on this antiviral research. This open-label Phase 2 trial will determine the early virologic response rate of patients after 12 weeks of therapy with Bavituximab, in combination with the antiviral drug ribavirin versus standard of care, pegylated interferon alpha 2a and ribavirin. PPHM also announced they expect to complete enrollment soon in an ongoing Phase Ib HCV trial and report data by mid-year.

Both trials in liver and pancreatic cancer are being conducted in combination with other chemotherapy agents in hopes of synergistic activity between the two to produce better results. This trial is being conducted in combination with the chemotherapeutic agent gemcitabine versus gemcitabine monotherapy. Prior research has shown that "combining the PS-targeting antibody bavituximab with gemcitabine (shown to increase PS exposure on tumor blood vessels) enhances anti-tumor effects and controls metastatic growth without added toxicity over gemcitabine alone in animal models of pancreatic cancer." In the liver cancer trial, they are hopeful that the "growth-blocking mechanisms of sorafenib with the vascular-targeting and immune-reactivation mechanisms of bavituximab offers additive anti-tumor effects for patients with HCC."

They are also investigating bavituximab in 2 Phase IIb clinical trials in non-small cell lung cancer (NSCLC), one of which is looking at the front-line setting with interim data expected sometime in mid-2011. Recently, they also announced that the last patient had been treated in their Phase 2 trial using Cotara in brain cancer (GBM). 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.

Joseph S. Shan, VP of clinical and regulatory affairs at Peregrine said, "We expect top-line data to be available by mid-year 2011 and plan to meet with the FDA to define the optimal registration pathway for Cotara." To us, it sounds like PPHM will have something in store for investors at ASCO 2011, on both the GBM and NSCLC fronts.

We also like their other business venture into bioprocessing, in which they just recently secured a development agreement for in the biosimilars arena. They also have a government contract to evaluate its phosphatidylserine-targeting antibodies for viral hemorrhagic fever which "provides up to $24.7 million in funding for the base period ending March 2011 for a total of up to $36.3 million in funding during the five-year potential duration of the contract," according to the company. Peregrine seems to have a highly diversified pipeline that is utilising external funding sources to help validate and explore some of their clinical candidates.

Roth Capital has high expectations for PPHM in 2011, with several upcoming data releases (Cotara and NSCLC Phase 2 results) as catalysts for partnering talks. Roth has them rated as a "BUY" with a $10 price target. At the end of 2010, PPHM entered into an At Market Issuance Agreement with MLV to the tune of $75 million. We view this deal positively, since it allows them to raise capital as share price increases and it is not selling them at a discount to a fund.They have one of the best unpartnered pipelines amongst small-cap biotechs and we are excited about the potential over at Peregrine.