Euthymics Bioscience, Inc., a clinical-stage company developing next-generation antidepressants, today announced that Pierre Trân, M.D., and Joan Manthis have been appointed as Chief Medical Officer and Director of Clinical Operations, respectively. These new additions to Euthymics’ senior management team bring the company a wealth of drug development experience to support development of EB-1010, its novel antidepressant drug candidate. Also joining the management team is William T. Pappafotopoulos as Vice President of Finance and Administration. He brings extensive experience in finance and accounting operations.

EB-1010 is a novel, broad-spectrum monotherapy antidepressant intended for use by the estimated two-thirds of major depression patients who do not respond adequately to current treatments. Euthymics is preparing to initiate a Phase II/III clinical trial of EB-1010 in the first half of 2011.

“The additions of Pierre and Joan to the Euthymics clinical team mark an important step in Euthymics’ development, as we move forward as a clinical development-stage company,” said Anthony A. McKinney, President, CEO and Co-Founder of Euthymics. “Pierre’s and Joan’s proven success and impressive backgrounds in developing innovative CNS therapeutics will be invaluable as we focus on the implementation of the clinical development plan for EB-1010. We believe this novel drug candidate has great potential to serve the millions of patients with major depression who do not respond adequately to currently available medications.”

Mr. McKinney continued, “Bringing Bill into our company with his depth of experience in finance and accounting with both private industry and the U.S. government further strengthens our management team. Together, these three appointments provide Euthymics with the experience and expertise to develop our lead product candidate and move ahead with our clinical program. We welcome Pierre, Joan and Bill to our team.”

Dr. Trân, who joins Euthymics as Chief Medical Officer, brings years of experience developing some of the most recognizable drugs in the antidepressant field. Dr. Trân served as Global Medical Director, Joint Antidepressant Group at Eli Lilly and Company where he was involved in the life-cycle management of fluoxetine (Prozac®). Importantly, Dr. Trân oversaw the clinical development effort that resulted in the successful regulatory approval of duloxetine (Cymbalta®) for the treatment of major depressive disorder and painful diabetic neuropathy. He was also involved in late-stage development and registration of Zyprexa® that led to its successful worldwide commercialization. After Lilly, he was Senior Vice President and Chief Medical Officer at XenoPort, and most recently, he served as Chief Medical Officer and Vice President, Clinical Development at Cortex Pharmaceuticals, where he led development efforts for several drug candidates targeting CNS disorders. Dr. Trân received an M.D. from the Université de Franche-Comté in France and a Masters in Medical Management (M.M.M.) from Tulane University. He completed his residency training at Duke University and holds an academic appointment as Assistant Consulting Professor in the Department of Psychiatry and Behavioral Sciences at Duke University Medical Center.

Ms. Manthis joins Euthymics as Director of Clinical Operations, bringing the company over 25 years of research and clinical trial management. Prior to joining Euthymics, Ms. Manthis served as Director of Clinical Operations at Orexigen Therapeutics. There, she was responsible for clinical operations for Contrave®, an investigational CNS drug for the treatment of obesity. Earlier in her career, Ms. Manthis worked at Eli Lilly and Company as Senior Clinical Development Associate, where she developed clinical programs in support of the Neuroscience Program Teams. Previously, Ms. Manthis held positions as Manager of Post-Marketing Research at MGI Pharma and as Senior Clinical Trial Leader and Clinical Research Supervisor at Medtronic, and she began her commercial career with positions of increasing responsibility at 3M Pharmaceuticals. She received an M.A. and a B.A. from the University of Minnesota.

Mr. Pappafotopoulos has been President and CEO of the Milton Financial Group, founded in 1985, serving venture capital, bioscience and financial firms, among others. Prior to forming the Milton Financial Group, Mr. Pappafotopoulos held financial, accounting and management positions in Fortune 100 companies, including Johnson & Johnson and Raytheon, and in the government, at the Internal Revenue Service. Mr. Pappafotopoulos received a B.S. in Accounting from Salem State University and an M.B.A. from Suffolk University.

About Euthymics Bioscience, Inc.

Euthymics Bioscience, Inc. is a neuroscience-focused clinical-stage company developing next-generation treatments for depression. Euthymics’ initial focus is on patients who do not respond adequately to selective serotonin reuptake inhibitors (SSRIs), which represent the majority of prescriptions for the antidepressant market. EB-1010 for depression is intended to improve efficacy as a single drug while reducing the leading side effects associated with poor adherence to standard antidepressants including weight gain and sexual dysfunction. Euthymics is a private Delaware corporation with headquarters in Cambridge, Massachusetts. Additional information can be found on the company’s website at www.euthymics.com.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN – News) announced today that it has acquired ZyStor Therapeutics, Inc. (ZyStor), a privately-held biotechnology company developing enzyme replacement therapies (ERT) for the treatment of lysosomal storage disorders. ZyStor’s lead product candidate is ZC-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for Pompe disease.

Under the terms of the agreement, BioMarin acquired ZyStor for $22 million upfront and up to an additional $93 million if certain development, regulatory and commercial milestones are achieved. There are no royalties owed. The FDA has accepted an investigational new drug (IND) application for ZC-701, investigational product has been manufactured and a clinical study is expected to start in Q1 2011.

In vitro studies demonstrate that ZC-701 has more than ten times higher affinity for the mannose-6-phosphate receptor compared to Myozyme, which enables delivery of higher levels of enzyme to the lysosomes of muscle cells of Pompe patients. Studies in the Pompe mouse model indicate that ZC-701 clears glycogen to lower levels in skeletal, heart and diaphragm muscle compared to Myozyme and at similar levels compared to second generation compounds that have been tested. Many experts believe that an enzyme with more efficient uptake into muscle cells would lead to more effective treatment of the disease. Over the next several months BioMarin plans to recruit clinical research hospitals that can conduct clinical studies and finalize the clinical protocol and expects the first patient dosed in the first quarter of 2011.

“The acquisition of ZyStor gives us the opportunity to introduce a superior product to fulfill an unmet medical need and is a perfect fit in our core business. It not only provides us with a promising product candidate for Pompe disease but also an exciting new platform technology,” said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. “ZC-701 has been shown to be more effective in the Pompe mouse model than commercially available replacement enzymes for Pompe disease. In addition, ZyStor’s proprietary Glycosylation Independent Lysosomal Targeting (GILT) technology is applicable to other ERTs and has the potential to deliver more enzyme to lysosomes compared to traditional mannose-6-phosphate targeted approaches. Also, relative to our internal candidate for Pompe, BMN-103, ZC-701 has a faster clinical development timeline, lower development costs, significantly lower cost of goods and lower capital investment.”

Mr. Bienaime continued, “As for the potential market opportunity, the incidence of Pompe is 1 in 40,000 births. The total market for Pompe is estimated at more than $1.0 billion, assuming 3,000 to 6,000 patients have access to high value therapeutics and an average cost of therapy that is comparable to other enzyme replacement therapies. We look forward to keeping you updated on this and other programs in our pipeline.”

Loren Peterson, President and Chief Executive Officer of ZyStor said, “We are very pleased to conclude this transaction with BioMarin for the development of ZC-701. BioMarin has a proven track record of successfully and expeditiously developing value-added therapies for orphan diseases, with particular strength in the field of enzyme replacement therapies for lysosomal storage disorders. Using our proprietary GILT technology, we believe that ZC-701 has the potential to be a more potent therapy for the treatment of Pompe disease.”

Conference Call Details

BioMarin will host a conference call and webcast today, Tuesday, August 17, at 5:00 p.m. ET. This event can be accessed on the investor section of the BioMarin website at www.BMRN.com.

Date: August 17, 2010

Time: 5:00 p.m. ET

U.S. / Canada Dial-in Number: 866.783.2143

International Dial-in Number: 857.350.1602

Participant Code: 81596241

Replay Dial-in Number: 888.286.8010

Replay International Dial-in Number: 617.801.6888

Replay Code: 32632590

About Pompe Disease

Pompe disease, a lysosomal storage disorder, is a progressive degenerative disease of the heart muscle, diaphragm and skeletal muscle. It is caused by a deficiency in the lysosomal enzyme acid alpha glucosidase which leads to the accumulation of glycogen in myocyte lysosomes and results in cell death. The incidence is one in 40,000 births. There are two main forms of Pompe disease: adult onset with an incidence of one in 57,000 births and infantile onset with an incidence of one in 138,000 births. The current standard of care is Genzyme’s Myozyme and Lumizyme. Prognosis with standard of care is stabilization of the disease or minor improvements for the majority of adult onset patients.

About BioMarin

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company’s product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine phosphate), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Other product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in clinical development for the treatment of MPS IVA and PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU. For additional information, please visit www.BMRN.com. Information on BioMarin’s website is not incorporated by reference into this press release.

About ZyStor Therapeutics, Inc.

ZyStor Therapeutics, Inc. is a privately held biotechnology company based in Milwaukee, Wisconsin developing a novel class of targeted protein therapeutics incorporating the company’s proprietary Glycosylation Independent Lysosomal Targeting (GILT) technology. Instead of using mannose-6-phosphate (M6P) containing oligosaccharides to target the mannose-6-phosphate receptor and deliver proteins to lysosomes, this proprietary technology uses a peptide tag to target the M6P receptor with high affinity. ZyStor’s lead product, ZC-701, has a much higher affinity for the M6P receptor compared to commercially available enzymes for Pompe disease and has been shown to be substantially more effective in clearing glycogen storage in the Pompe mouse model. In addition, preliminary studies indicate that GILT-tagged proteins actually induce more M6P receptor to appear on the cell surface compared to conventional replacement lysosomal enzymes, which may be particularly important for tissues that do not normally express high levels of M6P receptor, like skeletal muscle. GILT also offers substantial manufacturing advantages over making highly mannose-6-phosphorylated proteins. ZC-701 is a new molecular entity with unique composition of matter and claims to at least 2025, as well as 12 years of data exclusivity under the new healthcare reform. BMO Capital Markets acted as financial advisor to ZyStor in this transaction.

Forward-Looking Statement

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the expectations of the development and efficacy of ZC-701, an enzyme replacement therapy for the treatment of Pompe disease. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities, results and timing of current and planned preclinical studies and clinical trials related to such product; our ability to successfully manufacture the product; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s 2009 Annual Report on Form 10-K, and the factors contained in BioMarin’s reports on Form 10-Q. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.

BioMarin®, Naglazyme® and Kuvan® are registered trademarks of BioMarin Pharmaceutical Inc.

Firdapse™ is a trademark of BioMarin Huxley Ltd.

Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.

BioMarin has agreed to pay $22 million initially for privately held Zystor, based in Wauwatosa. BioMarin will pay as much as $93 million more if certain development, regulatory and commercial milestones are achieved, the company said.

The first of those additional payments would be for $13 million when the first patient is enrolled in a Phase III clinical trial for Zystor’s primary drug candidate, said Hank Fuchs, BioMarin’s chief medical officer, in a conference call.

The acquisition could give investors on the coasts a “more substantial appetite for deals in the Midwest because it shows them deals can go through the full life cycle, including harvesting their investment,” said George Arida, a managing director at Venture Investors, and Zystor’s chairman.

“We considered a number of strategic alternatives over the last couple of years, and I couldn’t be more pleased with this outcome,” Arida said.

Zystor develops enzyme replacement therapies for people suffering from disorders known as lysosomal storage diseases. There are more than 40 such disorders, which involve enzyme deficiencies. These rare diseases, which occur only when both parents are carriers, can be fatal unless enzyme therapy is delivered.

Zystor’s lead product candidate is intended to treat Pompe disease, a progressive degenerative disease of the heart muscle, diaphragm and skeletal muscle that occurs in one out of every 40,000 births. Zystor has received approval from the FDA to begin clinical trials for the drug. BioMarin expects to start the trials in the first quarter of 2011, Jean-Jacques Bienaime, BioMarin’s chief executive officer, said in the conference call.

Zystor’s compound is potentially more effective and safer than the candidate for treating Pompe disease that BioMarin has been developing, Bienaime said. It also has significantly lower manufacturing costs, a shorter development timeline, and a stronger patent position, he said.

Bienaime estimated the total market for Pompe to be about $1 billion.

The acquisition provides an exit for Zystor’s investors and “the funding that’s necessary in order to get this product to the market,” said Loren Peterson, the company’s president and chief executive officer.

It would have taken as much as $100 million of additional investment to bring Zystor’s first drug to market, Peterson said. Unless a company is located in Boston or on the west coast, it’s difficult to raise that kind of money, he said.

“This is what’s supposed to happen. You fund promising ideas with venture capital and develop them to a point where you can ultimately find a larger pharmaceutical company that funds the technology for further development,” Peterson said.

BioMarin will keep Zystor’s operations here until the end of the year. The deal has closed and Tuesday was Peterson’s last day with Zystor. Seven other employees will remain with the company, and some may be offered positions when the operations are moved to California, Peterson said.

Zystor’s technology was developed in St. Louis. The company moved to Wisconsin in early 2005 as a condition of an $8.5 million funding round led by Venture Investors and Milwaukee-based Mason Wells. It has raised a total of $14.5 million from investors, Peterson said.

The State of Wisconsin Investment Board was among the seven groups that invested in Zystor, said Tom Still, president of the Wisconsin Technology Council. Zystor is one of six companies the board has invested in since it began in 2000 making direct investments in state companies, Still said.

“This demonstrates those kinds of investments can pay off for major investors,” Still said.

NanoBio Corporation announced today that it has been awarded a seventh U.S. patent covering its novel nanoemulsion technology. The new claims encompass methods of treating Herpes Simplex I infections, including herpes labialis (commonly referred to as cold sores), using NanoBio’s proprietary anti-infective nanoemulsion product candidates.

“The issuance of this patent further demonstrates the novelty of NanoBio’s nanoemulsion platform for use in treating dermatological conditions”

This new patent covers NanoBio’s NB-001, a novel topical therapy for the treatment of cold sores that has been licensed to GlaxoSmithKline plc (GSK) in the United States and Canada for over-the-counter (OTC) use. NanoBio and GSK are currently preparing to initiate two Phase 3 clinical trials to confirm the efficacy and safety of 0.3% NB-001 and are targeted to launch the product in 2013 – 2014.

“The issuance of this patent further demonstrates the novelty of NanoBio’s nanoemulsion platform for use in treating dermatological conditions,” said James R. Baker, Jr., MD, chief executive officer and founder of NanoBio. “Given the remarkable safety profile of NB-001 and the clear efficacy demonstrated in our prior clinical trials, we expect NB-001 will make a meaningful contribution to the well being of the millions of people who suffer from cold sores.”

The development of the nanoemulsion platform began in the 1990s at the University of Michigan, and has since been supported by over $110 million in grants, investments and partnership funding. The newly issued patent (U.S. #7,767,216) is licensed from the University of Michigan to NanoBio Corp. on an exclusive, worldwide basis. With this new patent, NanoBio now holds seven U.S. patents and has filed over 30 additional U.S. and International applications.

Shares of TomoTherapy Inc. rose Wednesday after a Baird analyst upgraded the stock, citing the company’s niche position in the radiation therapy market.

THE SPARK: Analyst Jeff D. Johnson upgraded shares to “Outperform” from “Neutral” and boosted his price target to $5. He said market trends have improved for the company in recent months and TomoTherapy ( TTPY – news – people ) will likely maintain its current small share of the market. He said orders for radiation therapy systems could top 55 systems and installs could top 50 systems in 2010.

TomoTherapy makes radiation systems designed to target tumors while reducing exposure to surrounding healthy tissue.

THE ANALYSIS: “With our field checks improved, we’re incrementally comfortable TomoTherapy can maintain its status as a niche provider in the $3.6 billion worldwide radiation therapy market and that risk of a draconian fall-off in demand for the company’s products has fallen,” Johnson said, in a note to investors.

SHARE ACTION: Up 16 cents, or 5.1 percent, to $3.28 in morning trading. The stock has traded between $2.59 and $4.67 over the last 52 weeks.

Euthymics Bioscience, Inc., a clinical-stage company developing next-generation antidepressants, today announced the completion of a Series A financing — led by Novartis Venture Funds and Venture Investors – for a total investment commitment of $24 million in milestone-conditioned tranches. Hambrecht & Quist Capital Management, LLC, GBS Venture Partners and the State of Wisconsin Investment Board also participated in the financing. The initial Series A proceeds were used to complete the acquisition of DOV Pharmaceutical, Inc. and allow for the continued development of DOV’s unique antidepressant, EB-1010 (formerly known as DOV 21,947), for patients who do not respond adequately to selective serotonin reuptake inhibitors, or SSRIs. The merged company will operate as a privately held corporation with headquarters in Cambridge, Massachusetts.

“The antidepressant prescription market is among the largest, with an excess of 200 million prescriptions dispensed annually in the U.S. and a value exceeding $20 billion worldwide”

“This impressive commitment speaks to the potential of our clinical-stage entry into the antidepressant market,” said Anthony A. McKinney, President, CEO and co-founder of Euthymics. “We are addressing a significant unmet medical need, we have convincing Phase II proof-of-concept efficacy in major depression and we anticipate the start of a Phase II/III trial in the first half of 2011.”

Euthymics’ lead product, EB-1010, is intended for the estimated two-thirds of major depression patients who do not respond adequately to SSRIs. This segment is the single largest group of patients with depression and represents a major unmet medical need. EB-1010 is a novel unbalanced triple reuptake inhibitor which modulates serotonin, norepinephrine and dopamine. By “tuning” the affinity for each of these neurotransmitters in one molecule, EB-1010 is designed to improve efficacy and reduce side effects of current antidepressants, including weight gain, sexual dysfunction and cognitive impairment without the need for multiple prescriptions or complex titrations. The EB-1010 ratio of serotonin, norepinephrine and dopamine modulation is very similar to the triple combination given as multiple medications that was shown to improve outcomes in STAR*D, the large federally funded trial in major depression. EB-1010 has demonstrated proof-of-concept efficacy and attractive tolerability in patients with major depression.

“The antidepressant prescription market is among the largest, with an excess of 200 million prescriptions dispensed annually in the U.S. and a value exceeding $20 billion worldwide,” said Campbell Murray, M.D., Managing Director of Novartis Venture Funds, who will serve as Euthymics’ Chairman. “Euthymics enters this field with a ready-made market of underserved patients, a clinical-stage drug and an executive team with an impressive track record. In short, we have all the ingredients for success for our company and for our patients.”

Euthymics is led by an experienced management team. President and CEO Anthony McKinney was one of the original executives at Orexigen, where, as Chief Operating Officer, he helped take the company public and move its lead products into the clinic. He was also a member of the founding management team at Novazyme, and was Senior Vice President and General Manager at Genzyme after it acquired Novazyme for $137 million. Euthymics was co-founded by Franklin P. Bymaster, who will serve as Chief Scientific Officer. Bymaster spent over 33 years at Lilly and was involved with many of its successful CNS drugs including Prozac, Zyprexa, Strattera and Cymbalta.

Joining the Euthymics Board along with Dr. Murray are Paul Weiss, Ph.D., of Venture Investors, Frank Gentile, Ph.D., of Hambrecht & Quist Capital Management, LLC and Andrew Baker, Ph.D., of GBS Venture Partners.

When clinical trials begin next year, Maurizio Fava, M.D., Professor of Psychiatry at Harvard Medical School, Executive Vice Chair of the Department of Psychiatry at Massachusetts General Hospital and one of the leading depression experts worldwide, will serve as principal investigator.

In addition to EB-1010 for depression, the DOV acquisition gives Euthymics a pipeline of monoamine reuptake inhibitors for other CNS disorders including ADHD, obesity, anxiety, obsessive compulsive disorder and drug addiction.

First Patients With Stage 3 and 4 Chronic Kidney Disease Dosed at Two Sites

Akebia Therapeutics, Inc., a pharmaceutical discovery and development company focused on anemia and vascular disorders, today announced that it has initiated dosing in patients for a phase 2a single dose clinical trial of AKB-6548, an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) in development for anemia. Akebia recently completed a phase 1b study of AKB-6548 which demonstrated a dose-dependent increase in erythropoietin (EPO), reticulocytes (immature red blood cells) and hemoglobin with no significant adverse events.

“We recently successfully completed phase 1 studies, and are pleased to now begin testing AKB-6548 in patients with late-stage kidney disease seeking treatment for anemia,” said Joseph Gardner, Ph.D., president and chief executive officer of Akebia. “Patients with chronic kidney disease often suffer from anemia, and the current treatment approach involves injectable products to increase a patient’s level of EPO. AKB-6548 is an orally bioavailable product designed to naturally increase EPO, and we believe it will offer many advantages over current approaches including safety, dosing convenience and cost-effectiveness.”

The phase 2a study is designed to evaluate the safety, tolerability and pharmacokinetics of a single dose of AKB-6548 in stage 3 and 4 chronic kidney disease patients. In addition, the efficacy of AKB-6548 will be ascertained by measuring EPO and other biomarker responses including VEGF, hepcidin, transferrin and ferritin. The trial will involve up to 28 patients and will be conducted at two sites in the United States. The study is expected to be completed by January 2011.

About HIF-PH

Hypoxia-inducible factors (HIFs) are transcription factors that regulate the body’s response to decreases in oxygen, or hypoxia, in the cellular environment. HIF-PHs are the hypoxia-inducible factor prolyl hydroxylase enzymes that normally regulate the levels of HIF in bodily tissues. By inhibiting HIF-PH enzymes, HIFs can be stabilized or up-regulated, allowing the body to better respond to reduced oxygen, injury and infection. The ability to stabilize HIFs may lead to treatments for many conditions including anemia, fractures, wounds and other conditions where the HIF mechanism is not functioning optimally.

About AKB-6548

AKB-6548 is an orally bioavailable HIF-PH inhibitor designed to increase natural production of EPO, a glycoprotein hormone that controls red blood cell production. Inadequate EPO production by the kidney is a common cause of anemia. Akebia will initially target patients with chronic renal disease and pre-dialysis patients, two patient populations that are currently undertreated for anemia. AKB-6548 potentially promises to be a safe, cost effective, orally dosed drug that delivers the efficacy of injectable EPO stimulating agents.

The market for chronic anemia drugs, which generates over $10 billion in worldwide sales, is dominated by injectable forms of recombinant EPO. There are currently no orally dosed small molecule drugs for the treatment of chronic anemia.

About Akebia Therapeutics

Akebia Therapeutics is a discovery and development company focused on anemia and vascular disorders. Akebia’s lead program, AKB-6548, an orally bioavailable HIF-prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia, is in phase 2 clinical trials. AKB-6548 potentially promises to be a safer, less expensive, orally dosed pharmaceutical to stimulate endogenous EPO production. Additionally, Akebia has a novel HPTP beta inhibitor / Angiopoietin 2 modulator, AKB-9778, for the treatment of vascular leak syndrome and critical limb ischemia which is scheduled to commence phase 1 clinical trials in early 2011.