While many migraine sufferers experience traditional symptoms such as nausea or sensitivity to light and sound, migraine attacks can also involve symptoms like neck pain or sinus pain that are not traditionally associated with migraine headaches. New data show that significantly more patients using the investigational migraine treatment Trexima early in their migraine attacks were pain free at two hours and experienced relief from both traditional and non-traditional symptoms, compared to patients taking placebo. These data were presented today at the 59th Annual Meeting of the American Academy of Neurology.

In these studies, more than 1,100 patients treated more than 3,300 migraine attacks. At the beginning of the studies, many patients experienced traditional migraine symptoms: nausea (27-33 percent), sensitivity to light (69-74 percent) and sensitivity to sound (62-69 percent). Additionally, many patients also reported the non-traditional migraine-associated symptoms of sinus pain/pressure (39-44 percent) or neck pain/discomfort (59-61 percent).

"One of the challenges in migraine treatment is helping patients get relief for the specific symptoms associated with each attack," said Robert Kaniecki, MD, director of the Headache Center at the University of Pittsburgh. "These data are important because for the first time we have evidence of efficacy in treating both traditional and non-traditional migraine-associated symptoms across multiple migraine attacks."

Trexima, the proposed brand name for a single tablet containing sumatriptan 85 mg formulated with RT Technology(TM) and naproxen sodium 500 mg, is currently under review by the US Food and Drug Administration for the acute treatment of migraines in adults.

Understanding the Multiple Mechanisms of Migraine

Migraine pain is believed to be induced not only by the widening of the blood vessels, or vasodilation, but also involves neurochemical release and prostaglandin production. These mechanisms lead to inflammation, resulting in increased pain perception and sensitization of nerves. Understanding the multiple mechanisms of migraine may also explain why migraine sufferers often experience a variety of non-traditional migraine symptoms in addition to head pain, nausea or vomiting, and sensitivity to light and sound. Stimulation of the main sensory nerve may cause referral of pain to any of the nerve's three branches, resulting in sinus or facial pain; it may also cause referral of pain to the sensory nerves of the posterior head and neck, resulting in neck pain.

Relief from Non-Traditional and Traditional Migraine Symptoms

The data are from two identical multi-center, double-blind, placebo- controlled cross-over studies of adult migraine sufferers. The study incorporated an early intervention model, in which patients were instructed to treat while migraine pain was mild and within one hour of onset. Endpoints included post-treatment incidence of traditional symptoms, defined as nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to noise); and non-traditional symptoms, defined as sinus pain/pressure and neck pain/discomfort. Response to these symptoms was measured at two and four hours. This is the first study to evaluate traditional and non-traditional migraine-associated symptoms in a controlled early intervention setting across multiple attacks.

In both studies, patients taking Trexima reported a significantly lower incidence of traditional and non-traditional migraine-associated symptoms compared to placebo at two and at four hours.

-- The approximate difference between Trexima and placebo at two hours for each symptom was as follows: nausea (6 percent), sensitivity to light (22 percent), sensitivity to sound (18 percent), sinus pain/pressure (14 percent) and neck pain/discomfort (10 percent).

-- The approximate difference between Trexima and placebo at four hours for each symptom was as follows: nausea (12 percent), sensitivity to light (26 percent), sensitivity to sound (24 percent), sinus pain/pressure (16 percent) and neck pain/discomfort (16 percent).

In more than 1,100 patients treating more than 3,300 attacks, adverse events reported in at least 2 percent of patients within 72 hours of taking Trexima were nausea, dizziness, dry mouth, somnolence and fatigue.

About Imitrex(R) (sumatriptan succinate) Tablets

Imitrex is a prescription medication indicated for the acute treatment of migraine in adults. Imitrex should only be used when a clear diagnosis of migraine has been established. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or smoking, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.

About Naproxen Sodium

Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in Anaprox(R), Anaprox DS(R), Naprelan(R), Aleve(R) and in a number of over-the-counter medications. Naproxen sodium is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendinitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea. Naproxen-containing products should not be used by patients who have had allergic reactions to any product containing naproxen, nor in patients with asthma and nasal polyps in whom aspirin or other NSAIDs induce an exacerbation of asthma. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing medications. NSAIDs may cause increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke. This risk may increase with duration of use and in patients with cardiovascular disease or risk factors for cardiovascular disease. Serious gastrointestinal toxicity such as bleeding, ulceration and perforation can occur at any time in patients treated chronically with NSAID therapy and physicians should remain alert for such effects even in the absence of previous GI tract symptoms. Patients who are pregnant or are nursing should consult a physician before use of a naproxen-containing medication.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For detailed company information, see GlaxoSmithKline's website: gsk.

About POZEN

POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. Since its inception, POZEN has focused its efforts primarily on the development of pharmaceutical products for the treatment of acute and chronic pain, migraine and other pain related conditions. POZEN is also exploring the development of product candidates in other pain-related therapeutic areas. POZEN has a development and a commercialization alliance with GlaxoSmithKline. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN".

For detailed company information, including copies of this and other press releases, see POZEN's website: pozen.

Pozen Inc. sponsored and GlaxoSmithKline supported these studies.

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View drug information on Imitrex.

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) announced that it was notified by the U.S. Food and Drug Administration (FDA) that the company's premarket approval application (PMA) for the LightTouch™ Cervical Scanner, for patients at risk for cervical cancer, is "suitable for filing."

"Receiving the 'suitable for filing' letter from the FDA is a significant milestone in the regulatory review process and means that our application was sufficiently complete and is ready for substantive review," said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics. "This brings us one step closer to realizing our goal of improving the early detection of cervical disease and reducing the false positives and unnecessary biopsies that result with the current standard of care."

The FDA notification sets September 23, 2010 as the date of acceptance of the filing and states that FDA will schedule the Obstetrics and Gynecology Devices Panel meeting to review the PMA at a date to be determined.

More than $6 billion is spent each year in the U.S. alone to diagnose cervical cancer. The chance for successful treatment is greatly increased by early detection, according to the National Cancer Institute. Each year about 55 million Pap (Papanicolau) tests are performed in the U.S. to detect cervical abnormalities that could lead to cancer. Of these tests, approximately six percent are abnormal, requiring additional medical evaluation, such as a biopsy. However, the majority of biopsies reveal no cervical disease, meaning that a significant number of potentially avoidable procedures are performed every year.

In the pivotal trial to support the PMA filing, more than 1,600 women at risk for cervical disease were tested with the LightTouch™. Results of the trial showed that:

- LightTouch detected cervical disease up to two years earlier than Pap test, HPV (human papillomavirus) test, colposcopy and biopsy.

- LightTouch detected 86.3% of cervical disease cases that had been missed by Pap, HPV tests and biopsy.

- LightTouch would have reduced the number of avoidable biopsies by about 40 percent.

Additionally, Guided Therapeutics' clinical trial indicated that women aged 16-20 were just as likely to have cervical disease as women 21 and older and current methods of early detection, such as HPV testing, are not recommended for this age group. LightTouch detected cervical disease equally well in both adolescent and adult women.

About The LightTouch™

The LightTouch, which consists of a base unit and single-patient-use calibration disposable, scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively. Guided Therapeutics' patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and serious virus infections, provided an update on progress in the company's clinical program for Cotara(R), 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.

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. 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.

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(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc.

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.

Scientists from Biodel Inc. (Nasdaq: BIOD) reported new findings from the company's Linjeta™, insulin glargine, "smart" basal insulin and stabilized glucagon development programs in poster presentations yesterday and at the Tenth Annual Diabetes Technology Meeting in Bethesda, MD.

Dr. Frank Flacke presented results of a Phase 1 single-center, double-blind, randomized crossover trial in 13 subjects with type 1 diabetes who received a once-daily injection of Linjeta™ or one of two modified formulations of Linjeta™, each on a separate day ("Characterization of Pharmacokinetics and Toleration of Three Variant Formulations of Linjeta™"). The purpose of the study was to compare the pharmacokinetic characteristics and toleration of Linjeta™ to the two modified formulations. The study found that the modified formulations were associated with improved toleration profiles and lower maximal insulin concentrations compared to Linjeta. Modified formulation BIOD-102 was associated with a similar rate of absorption as Linjeta.

Dr. Roderike Pohl reported results of in vitro and preclinical testing of a modified form of insulin glargine in diabetic miniature swine to assess its duration of activity and pharmacokinetic profile compared to insulin glargine ("A New Formulation of Insulin Glargine with an Extended Release Profile"). The study found that certain excipients, when combined with insulin glargine, reduced the drug's solubility and could prolong its duration of action to greater than 24 hours compared to an average 18.5 hours for insulin glargine.

Nandini Kashyap described results of in vitro and in vivo studies in diabetic swine which showed that a "smart" basal insulin formulation can release insulin in response to changing glucose concentrations ("Smart Basal Insulin Formulation That Releases Insulin in Response to Changing Blood Glucose Concentrations"). This suggests that a modified form of basal insulin can be regulated based on insulin need, which would be expected to result in fewer hyper- and hypoglycemic excursions.

Dr. Solomon Steiner announced progress in the development of a stable form of glucagon for potential use in automated bihormonal pumps that deliver insulin and glucagon ("A Stabilized Glucagon Formulation For Bihormonal Pump Use"). Although generally unstable, glucagon can be used to prevent the hypoglycemia which occurs as a result of low or falling glucose concentration when too much insulin is administered. Biodel's glucagon was found to be chemically and physically stable beyond seven days and physiologically active after three days of exposure in diabetic miniature swine, suggesting its utility for use in a bihormonal pump.

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the complete response letter regarding the company's new drug application for Linjeta™; the company's response to the complete response letter; the importance of the complete response letter; and the company's focus, goals, strategy, research and development programs, and ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to respond to the complete response letter regarding our new drug application for Linjeta™ in a timely manner and the possibility that information we provide in response to the letter may not be accepted by the FDA; our ability to secure FDA approval for Linjeta™ and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel™ technology; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA's findings regarding data anomalies observed in India in our Phase 3 clinical trial of Linjeta™ for patients with Type 1 diabetes; the possibility that patients taking Linjeta™ may experience more injection site discomfort than they experience with competing products; unexpected data that may result from our clinical trials and our research and development activities; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent quarterly report on Form 10-Q for the quarter ended June 30, 2010. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

Chemical "relaxers" used to straighten hair are not associated with an increased risk of developing breast cancer among African-American women, say researchers who followed 48,167 Black Women's Health Study participants.

In the May issue of Cancer Epidemiology, Biomarkers & Prevention, researchers from Boston University and Howard University Cancer Center found no increase in breast cancer risk due to the type of hair relaxer used or the frequency and duration of use. Women who used relaxers seven or more times a year over a 20 year span or longer had the same risk as women who used the chemicals for less than a year, researchers say.

"This is good news," said the study's lead investigator, Lynn Rosenberg, Sc.D., professor of epidemiology at Boston University School of Public Health. "The present study is definitive that hair relaxers don't cause breast cancer, as much as an epidemiologic study can be."

Previous research shows that breast cancer incidence is higher among African-American women age 40 or younger than among Caucasian women of the same age, and this increased risk is not fully explained by known risk factors, such as race and family history. At all ages, African-American women are more likely to die of breast cancer than are Caucasian women. To shed light on these findings and to study potential causes of breast cancer and other serious illnesses that affect black women, the Black Women's Health Study was launched across the United States in 1995. More than 59,000 women completed an initial questionnaire and more than 80 percent have answered follow-up questions every two years since, including questions about use of hair relaxers.

Hair relaxers can enter the body through cuts or lesions in the scalp. These products are not fully monitored by the Food and Drug Administration, and thus could contain potentially harmful compounds, Rosenberg said. Manufacturers of hair relaxers and hair dyes are not required to list all ingredients of their products on the packages, as some may be considered trade secrets, she said.

"Because hair relaxers are more widely used by younger African-American women than they are used by older African-American women, a connection with increased risk of breast cancer in younger women seemed possible," Rosenberg said. "Also, millions of African-American women use hair relaxers, and substances that are used by millions of women over a span of many years should be monitored for safety."

The researchers found that younger women used hair relaxers more than older women did. They also discovered that the majority of women used hair relaxers before age 20 and a third used the chemicals at least seven times a year. But when they examined the association between use of hair relaxers and breast cancer, based on 574 newly diagnosed cases of breast cancer identified during the follow-up period, they found no connection between use of relaxers and breast cancer incidence overall or among the younger women, even if use had been frequent and of long duration.

The study was funded by the National Cancer Institute. Co-authors include Julie Palmer, Sc.D., and Deborah Boggs, M.S., of Boston University School of Public Health, and Lucile Adams-Campbell, Ph.D., of Howard University Cancer Center.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes nearly 26,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.

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