Eli Lilly and Company (NYSE:LLY) today announced it will begin enrolling patients in a second Phase III study of LY450139, a gamma-secretase inhibitor being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The study, called IDENTITY 2, is expected to enroll 1,100 patients from 22 countries. When its results are evaluated along with findings from the first Phase III trial, IDENTITY, a more complete understanding of dosing strategies will be available from a truly global sample of patient data. Because of the study design, IDENTITY 2 will give additional insights into how LY450139 might be dosed in a real-world clinical setting. Patients or caregivers interested in learning more about how to enroll in either IDENTITY study are encouraged to visit www.lillytrials.com or call 1-877-CTLilly (1-877-285-4559).
 

While the precise cause of Alzheimer's disease is not known, current theory is that subtypes of amyloid beta, a type of sticky protein, clump together and eventually kill brain cells, causing the symptoms of the disease. LY450139 is a once-daily oral agent that is believed to slow the progression of Alzheimer's disease by inhibiting gamma secretase, an enzyme that can create amyloid beta. By blocking gamma secretase, there is less amyloid beta formed and potentially less brain cell death.
 

"We are proud to begin a second global trial of our gamma-secretase inhibitor in patients suffering from the devastating effects of Alzheimer's disease," said Eric Siemers, M.D., medical director, Alzheimer's disease research for Eli Lilly and Company. "IDENTITY 2 is a study that we believe will give us additional insights into how LY450139 might best be given to patients in real clinical situations, information that is often not learned until a medicine is approved and prescribed in clinical practice. The start of this key trial is an important landmark for Lilly, especially considering the ongoing IDENTITY study, and the planned initiation of a Phase III study of our other investigational treatment for Alzheimer's disease, an anti-amyloid beta monoclonal antibody, next year. Lilly has a strong commitment to Alzheimer's disease -- we have an extensive early research program and are the only pharmaceutical company with two of its own Alzheimer's disease molecules in active late-stage development."

Alexza Pharmaceuticals, Inc. (NASDAQ:ALXA) announced today that it has initiated its second Phase 3 clinical trial with AZ-004 (Staccato(R) loxapine). AZ-004 is an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. Alexza believes the novel, non-invasive nature and rapid pharmacokinetic (PK) properties resulting from inhaled loxapine administration via the Staccato system have the potential to make AZ-004 a viable product to treat acute agitation. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC.
 

"We are excited to be advancing our AZ-004 NDA plan with the start of the second Phase 3 clinical trial this year. We look forward to enrolling this Phase 3 clinical trial as quickly as possible, and also releasing the initial results from our first Phase 3 study before the end of September," said Thomas B. King, Alexza President and CEO. "This year is a transitional year in our history, as we move into the commercial planning for the manufacturing, quality systems, regulatory submissions, and potential sales and marketing of AZ-004."
 

AZ-004 Second Phase 3 Clinical Trial Design
 

The second AZ-004 Phase 3 clinical trial is designed to enroll approximately 300 patients diagnosed with bipolar I disorder and acute agitation at 18 U.S. clinical centers. The trial is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study and will test AZ-004 at two dose levels, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. Patients eligible for the study include those who are admitted through an emergency department and those who are already in-patients in a hospital setting, as long as they have acute agitation at the time of patient randomization. This study is the first AZ-004 study enrolling bipolar disorder patients. Alexza projects that this second Phase 3 clinical trial will take approximately 12 months to complete patient enrollment.
 

The primary endpoint for the study is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, measured at 2 hours after the first dose. Various assessments of a patient's agitation state will be conducted at serial time points using standard agitation scales over the first 4-hour post-dose time period, with follow-up assessments at the end of the 24-hour study period. Side effects will be recorded throughout the 24-hour period.

CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system, today announced plans to advance its lead candidate Tyrima(TM) into Phase II trials for the treatment of depression and anxiety. This milestone is based on the positive results of the Tyrima Phase I program reported earlier this year and the recent completion of PET brain imaging studies showing that Tyrima penetrates the CNS and exhibits excellent pharmacokinetic and pharmacodynamic properties. Tyrima is a selective and reversible member of a novel class of drugs known as RIMAs, or reversible inhibitors of monoamine oxidase A (MAO-A).
 

"Tyrima has the potential to be the first triple-action antidepressant with a safety profile capable of treating a broad patient population, and we are very pleased with the promising properties Tyrima exhibited in these PET imaging studies," said Barry Brand, Chief Executive Officer of CeNeRx. "These encouraging results support our plans to initiate Phase II Tyrima trials in patients with major depression later this year."
 

"This innovative study used state-of-the-art PET imaging technology to demonstrate that Tyrima is penetrating and being eliminated from the brain in a consistent, predictable fashion," said Dr. Daniel Burch, Executive Vice President of R&D and Chief Medical Officer of CeNeRx. "Furthermore, the study has shown that plasma levels of Tyrima correlate extremely well with the action of Tyrima on MAO-A in the brain. This excellent pharmacokinetic/pharmacodynamic correlation has further increased our level of confidence in dose selection and the ability to demonstrate clinical efficacy as we move Tyrima into Phase II trials."
 

Like conventional MAOI agents, the triple-action mechanism of Tyrima elevates the levels of three key neurotransmitters (serotonin, norepinephrine and dopamine) that positively affect mood and anxiety. In contrast, most current antidepressant drugs affect only a single neurotransmitter. However, unlike these older MAOIs, the selectivity and reversibility of Tyrima should enable patients to benefit from the efficacy advantages of the class while avoiding the food-associated cardiovascular side effects of conventional MAOIs that have greatly restricted their use.
 

In January 2008, CeNeRx reported the successful completion of its Phase I program for Tyrima that included acute dose, repeat dose and fed-fasted studies. The Phase I studies showed that Tyrima was safe and well tolerated and exhibited good pharmacokinetic properties.
 

"This study is an excellent example of how PET imaging is both revolutionizing our ability to understand key CNS pathways and facilitating drug development," said Dr. Joanna Fowler, Director of the Center for Translational Neuroimaging at the U.S. Department of Energy's Brookhaven National Laboratory and Principal Investigator of the Tyrima PET imaging study. "Rather than relying on extrapolations from indirect measures, PET studies enable researchers to view exactly what happens when drugs are administered, enabling us to determine if the drug is doing what is intended and to identify optimal dosing levels. Results from this study confirm that Tyrima acts in the CNS as researchers had hypothesized and also gives greater assurance that the Phase II trial design will provide an accurate assessment of Tyrima's potential as a novel anti-depressant."
 

The first Tyrima Phase II trial is a double-blind, placebo-controlled, multi-center study expected to enroll over 270 patients with major depressive disorder. The study is expected to start before the end of this quarter.
 

"Tyrima is an investigational drug with promising antidepressant properties and CeNeRx has collaborated with leading PET imaging experts at Brookhaven National Laboratory to produce comprehensive data on how plasma levels of Tyrima affect pathways in the brain," said K. Ranga Krishnan, MD, Professor and Chairman, Department of Psychiatry and Behavioral Sciences at Duke University Medical Center, and CeNeRx SAB member. "An agent such as Tyrima with proven MAOI activity in the CNS and a good tolerability profile could be a valuable new therapy for patients affected by depression. Successful completion of this PET imaging study, coupled with the positive results from the Phase I program, support progression of Tyrima into Phase II trials."
 

PET, or positron emission tomography, is a nuclear imaging technology that produces three-dimensional depictions of metabolic states in the human body, allowing researchers to view the path and amount of drug accumulation in study participants. The PET imaging study showed that Tyrima entered into and left the brain, achieved high plasma concentrations and exhibited a favorable pharmacokinetic half-life. Further results will be submitted for presentation at a future scientific meeting or for inclusion in a peer-reviewed medical publication.
 

CeNeRx has worldwide rights to develop and commercialize Tyrima. This compound, which could be the first RIMA antidepressant available in the U.S. market, has patent protection beyond 2027.

Hyperion Therapeutics, Inc. today announced that it has completed patient enrollment in its Phase 1/2 clinical trial to evaluate the safety, tolerability and ammonia scavenging effects of HPN-100 (formally called GT4P) versus BUPHENYL(R) (sodium phenylbutyrate) in patients with urea cycle disorders (UCD).  The company plans to announce top-line results in the fourth quarter of this year.

"Completing enrollment in this Phase 1/2 study is an important milestone in our development program," said Bruce Scharschmidt, Chief Medical Officer of Hyperion Therapeutics. "This represents the first trial of HPN-100 in patients with UCDs and the results will be important in assessing its potential to improve care for these patients."

About Urea Cycle Disorder

UCDs are inherited, inborn errors of metabolism present in an estimated 1 in 10,000 births in the US.  Patients with UCDs lack or are deficient in one of the key enzymes that comprise the urea cycle, the body's primary vehicle for removing ammonia, a potent neurotoxin, from the bloodstream.  UCDs often present in the neonatal period, but onset can occur at any age depending on the severity of the disorder.  Left untreated, UCDs can cause dangerously heightened levels of ammonia in the bloodstream (hyperammonemia) resulting in brain damage, coma, and/or death.

About HPN-100

HPN-100 is a pro-drug of phenylbutryrate and a pre-pro-drug of phenylacetic acid (PAA), the active moiety of BUPHENYL(R), the only therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle disorders -- carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), and argininosuccinic acid synthetase (AS). HPN-100, which is dosed orally in liquid form, provides an alternative pathway to the urea cycle for the disposal of waste nitrogen through the renal excretion of phenylacetylglutamine, which is formed from PAA and glutamine.

About BUPHENYL(R)

BUPHENYL(R) is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). BUPHENYL(R) should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation. The most common adverse reactions associated with BUPHENYL(R) were amenorrhea dysfunction, decreased appetite, body odor (probably caused by its metabolite phenylacetate) and bad taste or taste aversion. Patients with urea cycle disorders should not take valproic acid, haloperidol, or steroids as these drugs have been reported to increase blood ammonia levels, and probenecid may affect the kidneys' excretion. Use with great care, if at all, in patients with congestive heart failure or severe renal insufficiency, and in clinical states where there is sodium retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established.
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Dendreon Corporation (NASDAQ:DNDN) today announced that the Company has initiated a Phase 2 trial of PROVENGE(R) (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of prostate cancer, in men with localized prostate cancer who are scheduled to undergo a radical prostatectomy. The single-center trial called NeoACT (NEOadjuvant Active Cellular immunoTherapy), or P07-1, which is being conducted at UCSF Helen Diller Family Comprehensive Cancer Center, has begun enrolling approximately 40 patients. NeoACT is the first of two new Phase 2 trials of PROVENGE being initiated this year.
 

Each patient will receive a complete course of active treatment over a one-month period beginning six to seven weeks prior to the patient's radical prostatectomy. The course of treatment will consist of three infusions of PROVENGE-two weeks apart. Multiple safety and efficacy endpoints will be evaluated including the immune response in the prostatectomy specimens and in the peripheral blood. Following radical prostatectomy, patients will be randomized to receive either a booster of PROVENGE or no booster. Patients interested in additional information about this trial may visit http://www.clinicaltrials.gov/ and use the search term "NeoACT."
 

"I am pleased to help lead the NeoACT clinical trial, given the therapeutic potential of immunotherapy for prostate cancer," stated Lawrence Fong, M.D., principal investigator of the NeoACT trial and associate professor of medicine at UCSF Helen Diller Family Comprehensive Cancer Center. "This study will provide a unique opportunity to examine the immune response to PROVENGE in actual prostate cancer tissue and to examine the correlation between immune responses in the tissue versus those in the circulating blood."
 

"Given the evidence of a survival benefit seen in our previous Phase 3 trial, D9901, in patients with advanced prostate cancer, we believe PROVENGE may also have applicability to men with earlier stages of the disease. This trial will help us better understand the mechanism of action and biology of PROVENGE, as well as evaluate the potential of PROVENGE in patients at high-risk for recurrence of their cancer following radical prostatectomy," stated Mark Frohlich, M.D., senior vice president, clinical affairs and chief medical officer of Dendreon. "We are highly focused on taking the steps necessary to get PROVENGE through the FDA approval process in order to get this important immunotherapy to prostate cancer patients with advanced disease who do not have any other reasonable options. We are on track to complete the interim analysis of our ongoing Phase 3 IMPACT trial during the latter half of this year."

Spherix Incorporated (NASDAQ:SPEX) reported that the Phase 3 clinical trial of its potential type 2 diabetes drug, Naturlose(R), will expand outside of the United States. Several countries with high prevalence of treatment-naive type II diabetics are being considered. "This expansion abroad should allow us to finish enrollment in the first quarter of 2009, which is consistent with the timeline reported at the recent Shareholders Meeting. What makes the sites we are considering so attractive is their ability to gain regulatory approval and recruit a large number of patients in a very short period of time," said Randy W. Brown, Chief of Operations. Mr. Brown reported that, as of June 30, 2008, 155 subjects of the required 450 have been randomized into the trial and are under study.
 

Recent media reports in the U.S. about the Phase 3 trial have accelerated inquiries by prospective patients who would like to participate in the trial. Stories appeared in Maryland's Baltimore Sun and on Pittsburgh, Pennsylvania's KDKA following publication of a report in the peer-reviewed journal Diabetes, Obesity And Metabolism(1-3). Thomas Donner, M.D., medical director of University of Maryland's Joslin Diabetes Center, said that if the drug works on diabetes, there could be more trials to show efficacy in weight reduction. Dr. Donner has noted that people in previous smaller trials also lost weight.
 

The Company also announced that it has successfully petitioned the FDA to eliminate the need for pre-mixed solutions for the delivery of study medicine to participants. "This convenient form of dosing reflects the expected delivery method of Naturlose once it gains approval. The change is expected to enhance recruitment and compliance in the trial. This is a significant advancement for the Company, our investigators and their patients," said Mr. Brown.
 

1. Yongming Lu, Gilbert Levin, Thomas Donner. "Tagatose, a New Anti-Diabetic and Obesity-Control Drug." Diabetes, Obesity and Metabolism. 10, 2008, 109-134.
 

2. Meredith Cohn, "Sweet Hope, The natural sugar tagatose, once a Slurpee sweetener, could help diabetes patients control blood glucose levels." Baltimore Sun, March 27, 2008.
 

3. Sugar Treatment Could Help Diabetes Patients, Jun 30, 2008 8:21 pm US/Eastern, http://kdka.com/health/sugar.diabetes.Tagatose.2.760164.html (click on "Related" to watch the video).
 

Certain statements contained herein are "forward looking" statements as defined in the Private Securities Litigation Reform Act of 1995. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied. Factors that could cause actual results to differ materially from those expressed or implied include, but are not limited to, those discussed in filings by the Company with the Securities and Exchange Commission, including the filing on Form 8-K made on October 10, 2007.
 

Spherix's mission is to create value and increase shareholder wealth through innovations that benefit our clients and the human condition. Spherix offers innovations in biotechnology, and provides technical and regulatory consulting services to biotechnology and pharmaceutical companies.

MAP Pharmaceuticals, Inc. (NASDAQ:MAPP) today announced it has initiated its Phase 3 clinical program to evaluate MAP0004 as a potential treatment for migraine.

MAP0004 is orally inhaled and self-administered at home using MAP Pharmaceuticals' proprietary Tempo(R) inhaler.  In the company's prior Phase 2 efficacy study, MAP0004 provided pain relief in as fast as 10 minutes, with relief sustained through at least 24 hours.  The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia, the other key measurements in treating migraine.

This randomized, double-blind, placebo-controlled Phase 3 trial is designed to evaluate the efficacy and safety of MAP0004 in treating acute migraine.  The primary efficacy endpoints will be pain relief, and freedom from nausea, photophobia and phonophobia as measured at two hours after dosing.  MAP will also evaluate earliest onset of pain relief and sustained relief to 24 and 48 hours.  The multi-center efficacy trial will include approximately 850 patients, who will also be followed for 12 months in an open-label study to confirm long-term safety.

"We believe that MAP0004 has the potential to be a first-line therapy for migraine patients," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals.  "Based on our initial clinical studies, we believe that MAP0004 offers an alternative to triptans that may provide patients with the benefits of rapid onset and long-lasting pain relief, in an easy-to-use, non-invasive, at-home therapy.  In our Phase 2 trials, MAP0004 was well tolerated with no effect on pulmonary function, including in asthmatic subjects."

The therapeutic agent in MAP0004 is dihydroergotamine (DHE), which has a long history of use as a safe and effective migraine treatment.  Many headache specialists consider DHE administered by injection to be the standard of care in treating chronic migraine and debilitating migraines that last more than 72 hours.  MAP Pharmaceuticals is seeking to expand the use of this compound to treat migraines early, non-invasively and with a fast onset of action.

MAP Pharmaceuticals is initiating the first Phase 3 trial of its MAP0004 product candidate pursuant to a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration.  The SPA is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application.  In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.

Edison Pharmaceuticals, Inc., a privately held biotechnology company located in San Jose, CA, announced today that EPI-A0001 (A0001) has entered clinical development, triggering a milestone payment from Penwest Pharmaceuticals, Edison's development partner. Penwest has begun dosing in a Phase 1a clinical trial of A0001, a 2nd generation coenzyme Q10 (CoQ10) analog. It differs from CoQ10 in that it possesses more favorable oral absorption and electron transfer properties.
 

CoQ10 is a first-line therapy for many rare diseases of energy metabolism. Efforts to improve CoQ10 have centered on improving its oral absorption properties. Edison's focus is on building next-generation CoQ10 analogs through improving its electron transfer, otherwise known as redox, properties. Edison is a leader in the design and development of redox drugs.
 

Edison's initial therapeutic focus is on rare inherited mitochondrial diseases. Today, there are no FDA- approved treatments for these diseases. CoQ10, and closely related analogs, have been deployed with real, but limited clinical results. Edison's strategy is to improve upon CoQ10's biological activity by optimizing its redox properties. A0001 is the first redox-optimized CoQ10 analog in Edison's clinical development pipeline.
 

Edison's technical focus is on redox drugs targeting metabolic control and energy metabolism. Children with inherited mitochondrial defects clinically present with many conditions commonly associated with aging. Edison believes that inherited mitochondrial diseases may be genetic roadmaps to deciphering the biochemical basis of metabolic control and aging. Given CoQ10's known role in mitochondrial disease and aging, as well as its redox activity, Edison's initial investigations are focusing on the development of CoQ10 based drugs.
 

"Today we have reached a key milestone in transforming Edison from a discovery to development-stage company," stated Guy Miller, M.D., Ph.D., Chairman and CEO of Edison. "A0001's entry into Phase 1 is the first step in validating Edison's platform and providing needed therapies for patients suffering from rare mitochondrial diseases. As we look toward the future, we expect to focus our energies on refining our approach to treating rare mitochondrial diseases, and expanding our investigation of redox drugs for the treatment of diseases of aging."

Rib-X Pharmaceuticals, Inc. ("Rib-X" or the "Company"), a development-stage company focused on the discovery and development of novel antibiotics for the treatment of antibiotic-resistant infections, today announced the initiation of a Phase 2 clinical trial for an intravenous form of antibiotic compound RX-3341 in the treatment of complicated skin and skin structure infections (cSSSIs). The safety and efficacy study will be conducted at 35 sites across the United States. As a precursor to this news the Company also announced positive results of a two-part Phase 1 study with the same candidate.
 

"We have made significant progress in advancing this next-generation broad spectrum antibiotic further toward clinical use," said Dr. Susan Froshauer, President and CEO of Rib-X. "We intend to rapidly move forward with the development of our IV dosage form to meet the need for a broad-spectrum antibiotic in the hospital setting, particularly one that is active against quinolone-resistant MRSA. We also hope to further progress our oral dosage form to ensure a greater diversity of use in the treatment of serious infections in a number of settings."
 

Phase 2 Study Design
 

This Phase 2 double-blind study (study RX-3341-201) will evaluate the safety and efficacy of RX-3341 at two different doses administered intravenously to hospitalized cSSSI patients every 12 hours for 5 to 14 days, as compared to tigecycline (Tygacil(TM)). The study's primary endpoint is the assessment of RX-3341 efficacy, safety and tolerability at the two different doses compared to that of tigecycline's standard dosing regimen. A secondary endpoint for the study is the assessment of clinical efficacy of RX-3341 compared to tigecycline in patients with cSSSIs caused by methicillin- resistant Staphylococcus aureus (MRSA).
 

Phase I Results
 

The two-part Phase 1 study (RX-3341-103) compared the safety, tolerability and pharmacokinetics of two intravenous formulations of RX-3341. Part 1 of the study was designed to compare the safety and pharmacokinetics of the two IV formulations, with the purpose of optimizing the formulation of the IV dosage form. Twelve individuals received one dose of each of the formulations in a cross-over design. The two formulations were thus shown to be comparable in terms of exposure.
 

Part 2 of the study was designed to assess the safety, tolerability and pharmacokinetics of the optimized intravenous RX-3341 formulation. Results showed that the chosen intravenous RX-3341 formulation was well tolerated using multiple doses for 14 days.
 

About RX-3341
 

RX-3341 is a novel, broad spectrum fluoroquinolone antibiotic which has shown increased activity against gram-positive organisms compared to other quinolones, and similar or better activity to that of ciprofloxacin against gram-negative organisms in in-vitro studies and twelve Phase I and two Phase 2 clinical trials of the oral dosage form.
 

About Rib-X Pharmaceuticals, Inc.
Rib-X Pharmaceuticals, Inc. is a product-driven small molecule drug discovery and development company focused on the structure-based design of new classes of antibiotics. The Company's underlying drug discovery engine capitalizes on its proprietary high-resolution crystal structure of the ribosome, which performs an essential role in the fundamental process of protein synthesis. Many known, commercially valuable antibiotics bind to the ribosome, including those used to treat both community-acquired and hospital- acquired pathogens. The Company's integrated research strategy, which combines state of the art, proprietary computational analysis, X-ray crystallography, medicinal chemistry, microbiology and biochemistry, allows it to rapidly synthesize new agents designed to avoid typical antibiotic resistance mechanisms. Rib-X's iterative intelligent engine has yielded several distinctive new antibiotic classes. The Company currently has two programs in human clinical trials, the RX-1741 designer oxazolidinone program as an oral/IV agent to treat serious hospital Gram-positive infections and the RX- 3341 program, a next generation fluoroquinolone, active against a broad spectrum of bacteria, including methicillin-resistant Staphylococcus aureus. Additionally, the Company has multiple drug discovery programs. The first of these programs is focused on design and development of an orally active macrolide for community use for treatment of skin infections, including those caused by MRSA. The second discovery program is directed towards identifying a new chemical class of antibiotics active against multi-drug resistant Gram- negative bacteria.
 

For more information on the ribosome and the Rib-X mission, please visit the Company website at www.rib-x.com.

Sinovac Biotech Ltd. (AMEX:SVA) , a leading provider of vaccines in China, today announced the initiation of volunteer enrollment in its Phase II clinical trial for its split pandemic influenza vaccine. The preliminary results from this study are expected to be available in early 2009.
 

The randomized and double-blind trial is expected to enroll 210 adolescents, between the ages of 12 to 17, who will receive doses of 10ug, 15ug or 30ug, and 140 children, between the ages of 3 to 11, who will receive doses of 10ug or 15ug. Volunteers will be followed for two months with safety and immunogenicity data collected for the assessment of the vaccine.
 

Mr. Weidong Yin, Chairman, President and CEO, commented, ''Split influenza vaccine is believed to cause less adverse reactions in children compared to whole-viron influenza vaccine. Sinovac's split pandemic influenza vaccine aims at protecting the pediatric and adolescent population. Based on the positive safety results of the Phase I trial, the Phase II study will be conducted to further collect the vaccine's safety data in children and adolescents, as well as assessing the immunogenicity of different doses.''
 

Sinovac received approval from the China State Food and Drug Administration (SFDA) in April 2007 to conduct clinical trials for two types of the H5N1 vaccine, namely Phase Ib and II trials of the H5N1 whole viron vaccine and Phase I and Phase II trials of the H5N1 split vaccine. In December 2007, Sinovac reported positive top-line results from the completed Phase II clinical trial of Panflu(TM), its pandemic influenza (H5N1) whole viron inactivated vaccine. In April 2008, Panflu(TM) was granted a production license by the China State Food and Drug Administration (SFDA). Panflu(TM) is the first and only approved vaccine available in China against the H5N1 influenza virus.