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WCTF.org Transplant NewsTransplant news, links, and other general medical news -- updated regularly.Thursday, May 8, 2008New group for organ donors enhances transplant chances (KTAR 92.3 Phoenix)
New group for organ donors enhances transplant chances (KTAR 92.3 Phoenix)
There's now an organ donor program that claims to give you a better job at getting a transplant if you ever need one. It's called lifesharers.org. It's as easy as signing up, says Lifesharers Executive Director Dave Undis. Australia kidney specialist sparks organ sales row (AFP via Yahoo! News)
An Australian kidney specialist sparked a bitter medical ethics row Monday by calling for organ sales to be legalised to stop patients travelling overseas to buy them on the black market. [full story]
New group for organ donors enhances transplant chances (KTAR 92.3 Phoenix)
There's now an organ donor program that claims to give you a better job at getting a transplant if you ever need one. It's called lifesharers.org. It's as easy as signing up, says Lifesharers Executive Director Dave Undis. [continued]
Novadaq Technologies Notice of Annual Meeting
Novadaq Technologies Notice of Annual Meeting
TORONTO, May 8 /PRNewswire-FirstCall/ -- Novadaq(R) Technologies Inc. (TSX: NDQ), a developer of real-time imaging and image guidance systems for use in the operating room, will be holding its annual meeting, hosted by Dr. Arun Menawat, President and Chief Executive Officer and Mr. Roger Deck, Chief Financial Officer. DATE: May 15, 2008 TIME: 9:30 am, Eastern Daylight Time LOCATION: Saint Andrews Club WEBCAST: A live audio webcast of the call will be available at Webcast attendees are welcome to listen to the Please connect to this website at least 15 minutes About Novadaq Technologies Novadaq Technologies Inc. commercializes real-time imaging and image guidance systems for use in the operating room. With one set of proprietary core technologies, Novadaq's products have multiple applications. Novadaq's SPY System enables cardiac surgeons to diagnose intra-operatively by visually assessing coronary vasculature and bypass graft functionality during the course of heart bypass surgery. The SPY System is also indicated for use during other surgeries, such as cardiovascular, plastic, reconstructive, organ transplant and urological procedures. SPY can be used to visualize blood vessels, tumors, tumor margins and the lymphatic system. Novadaq introduced PINPOINT, its first minimally invasive imaging system for autofluorescence in October 2007. PINPOINT allows surgeons to differentiate between healthy and cancerous tissue in the lung and other hollow organs. Further expanding its portfolio of minimally invasive products, Novadaq is developing SPYscope which combines the typical features of a standard endoscope with the additional capabilities of SPY imaging. Novadaq is the exclusive United States distributor of PLC Medical's CO2 HEART LASER System, used in the same cardiac procedures as the SPY System. Novadaq also offers the OPTTX(R) System, which leverages the company's core imaging technology and is designed for the diagnosis, evaluation and treatment of wet Age-related Macular Degeneration (AMD). For more information, please visit the company's website at www.novadaq.com. Forward looking Statements Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Novadaq's current beliefs as well as assumptions made by and information currently available to Novadaq and relate to, among other things, results of future clinical tests of PINPOINT and the SPY System, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Novadaq in its public securities filings actual events may differ materially from current expectations. Novadaq disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: visit our website at www.novadaq.com, or contact: Arun Menawat,
Astellas Faces Setback Over Approval of Organ Transplant Drug (Bloomberg.com)
May 7 (Bloomberg) -- Astellas Pharma Inc. , Japan's second- largest drugmaker, faced more delays in the U.S. over the approval of a new version of its immunosuppressant Prograf. [read more]
The 29th Annual DC101 Chili Cook-Off Benefiting the National Kidney Foundation
The 29th Annual DC101 Chili Cook-Off Benefiting the National Kidney Foundation
WASHINGTON, May 8 /PRNewswire-USNewswire/ -- The following is being issued by the National Kidney Foundation of the National Capital Area: Who: Musical acts including headlining sets from Staind and Live, as well as Seether, Finger 11, Chevelle, Deaf Pedestrians and the winner of DC 101's Last Band Standing Contest, The Blackjacks; top chili chefs from around the area and local celebrity chili judges including America's Next Top Model finalist Sara Albert. What: 29th Annual DC101 Chili Cook-Off Benefiting the National Kidney Foundation of the National Capital Area When: Saturday, May 10 Where: Site of the former Washington Convention Center Why: The Washington, DC area leads the nation in the prevalence of kidney disease with more than 500,000 people affected, 4,800 on dialysis, and 1,700 waiting for a life-saving kidney transplant. The DC101 Chili Cook-Off raises funds to support medical research, patient and community services, professional education, and organ donation awareness. Additional Information: The mission of the National Kidney Foundation is to prevent kidney and urinary tract diseases, improve the health and well being of individuals and families affected by these diseases, and increase the availability of all organs for transplantation. For additional media and event information contact Michele Anthony or Nicole Hawkins at 202-244-7900. For band information, contact Cruze at DC101, 301-587-7128. First Call Analyst:
CONTACT: Michele Anthony or Nicole Hawkins, both of National Kidney
Leading Plastic Surgeons at Duke Adopt SPY
Leading Plastic Surgeons at Duke Adopt SPY
SPY Used to Plan and Optimize Reconstruction Surgery TORONTO, May 8 /PRNewswire-FirstCall/ -- Novadaq(R) Technologies Inc. (TSX: NDQ), a developer of real-time imaging and image guidance systems for use in the operating room, announced today that plastic surgeons at Duke University Hospital in Durham, North Carolina are routinely using the SPY(R) Imaging System in plastic reconstructive surgical procedures. Since beginning to use SPY near the end of 2007, L. Scott Levin, M.D. and Michael R. Zenn, M.D., have completed 50 SPY procedures during a variety of muscle, bone and free tissue or "perforator flap" plastic reconstructive surgeries for the treatment of traumatic injuries, congenital deformities and various cancers. Use of a patient's own tissue to create a new body part is rapidly gaining popularity. In these surgeries, tiny vessels called perforators provide the blood supply to a tissue "flap" known as a "perforator" flap. These flaps can be transferred from numerous donor sites to almost any other part of the body. During the procedure, these microscopic sized vessels are co-joined to recipient vessels to supply blood to the reconstructed tissue. Locating the most appropriate perforator vessel is critical to achieving successful outcomes, but is often a lengthy process for the surgeon and OR team. In the past, surgeons have used doppler ultra-sound and most recently computer tomography (CT) scanning to assist the identification process. However, since perforator vessels are so small, doppler ultra-sound has often been ineffective and CT cannot be performed in the operating room. The SPY System is the only fluorescent imaging system that enables plastic surgeons to visually assess blood flow in co-joined vessels, micro-vasculature and related tissue perfusion in real-time. Drs. Levin and Zenn were the first to use SPY to intra-operatively locate and assess the quality of perforator vessels. Drs. Levin and Zenn are in the process of completing an independent clinical study using SPY to identify perforator vessels prior to flap harvest and are comparing SPY intra-operative imaging to pre-operative CT. Drs. Levin and Zenn intend to submit the results of their study to a peer reviewed scientific journal in the near future. "Our initial experience indicates that SPY has great potential to improve the technical performance and results of perforator flap reconstructive surgery," said Dr. Levin, Professor and Chief of Plastic Surgery at Duke. "If, as we believe today, the results of our study find SPY to be equally as effective in identifying perforator vessels in the OR as pre-op CT, there is no doubt that the clinical benefits and cost savings will lead toward establishing SPY as a standard of care in our specialty." "The goal of any plastic reconstructive surgery is to restore a patient's body to the most anatomically normal and cosmetically satisfying state as possible. In the majority of cases, these goals are challenging because no two surgeries are exactly alike," said Dr. Michael Zenn, Associate Professor of Plastic Surgery at Duke. "SPY provides us the instant visual imaging feedback we need to confidently make decisions in the OR to achieve the best possible results for each individual patient." About Novadaq Technologies Novadaq Technologies Inc. commercializes real-time imaging and image guidance systems for use in the operating room. With one set of proprietary core technologies, Novadaq's products have multiple applications. Novadaq's SPY System enables cardiac surgeons to diagnose intra-operatively by visually assessing coronary vasculature and bypass graft functionality during the course of heart bypass surgery. The SPY System is also indicated for use during other surgeries, such as cardiovascular, plastic, reconstructive, organ transplant and urological procedures. SPY can be used to visualize blood vessels, tumors, tumor margins and the lymphatic system. Novadaq introduced PINPOINT(TM), its first minimally invasive imaging system for autofluorescence in October 2007. PINPOINT allows surgeons to differentiate between healthy and cancerous tissue in the lung and other hollow organs. Further expanding its portfolio of minimally invasive products, Novadaq is developing SPYscope which combines the typical features of a standard endoscope with the additional capabilities of SPY imaging. Novadaq is the exclusive United States distributor of PLC Medical's CO(2) HEART LASER System, used in the same cardiac procedures as the SPY System. Novadaq also offers the OPTTX(R) System, which leverages the company's core imaging technology and is designed for the diagnosis, evaluation and treatment of wet Age-related Macular Degeneration (AMD). For more information, please visit the company's website at www.novadaq.com. Forward looking Statements Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Novadaq's current beliefs as well as assumptions made by and information currently available to Novadaq and relate to, among other things, results of future clinical tests of PINPOINT and the SPY System, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Novadaq in its public securities filings actual events may differ materially from current expectations. Novadaq disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: visit our website at www.novadaq.com, or contact: Arun Menawat,
Vion Pharmaceuticals Announces Initiation of Clinical Trial of Cloretazine(R) (VNP40101M) in Combination with Cytarabine
Vion Pharmaceuticals Announces Initiation of Clinical Trial of Cloretazine(R) (VNP40101M) in Combination with Cytarabine
NEW HAVEN, Conn., May 8 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (NASDAQ:VION) today announced the start of an investigator-sponsored Phase I/II clinical trial of its lead anticancer agent Cloretazine(R) (VNP40101M) in combination with cytarabine in elderly patients with previously untreated acute myelogenous leukemia (AML) and high-risk myelodysplastic syndromes (MDS). The trial is being conducted under the direction of Ellen K. Ritchie, M.D. at The Weill-Cornell Medical College in New York City. Co- investigators for the study are Eric Feldman, M.D. and Gail Roboz, M.D. The objectives of the trial are: (i) to define the maximum tolerated dose (MTD) of Cloretazine(R) (VNP40101M) when given in combination with cytarabine to AML and high-risk MDS patients over the age of 60, and (ii) to evaluate this combination further for safety and efficacy in a larger cohort of patients. Cloretazine(R) (VNP40101M) will be given as a 30 - 60 minute infusion on day 1 approximately 3-4 hours after the start of the cytarabine infusion. Cytarabine will be administered as a continuous infusion of 100 mg/m2/day for 7 days. In the Phase I portion of the study, dose escalation will be done in cohorts of at least 3 patients and the maximum tolerated dose (MTD) identified in the Phase I segment will be used in the Phase II segment of the study. Ann Cahill, Vice President, Clinical Development, commented, "It is important for us to continue to study Cloretazine(R) (VNP40101M) in combination with different doses and schedules of cytarabine, the most widely used drug in the treatment of AML. In addition, we want to evaluate Cloretazine(R) (VNP40101M) in a broader group of elderly patients than are currently being studied in our pivotal trial of Cloretazine(R) (VNP40101M) as a single agent." Ms. Cahill concluded, "Cloretazine(R) (VNP40101M) has shown activity in AML and MDS, warranting further study in the treatment of these devastating conditions as both a single agent and in combination with other therapies." Dr. Ritchie commented, "We are enthusiastic to begin exploring this regimen for AML and MDS patients that are over the age of 60. As standard therapies for these individuals have shown to be inadequate, there exists a need for our continued attention to research and development of new treatment options. Preliminary clinical trials using Cloretazine(R) (VNP40101M) in combination with cytarabine have demonstrated favorable activity and compelling evidence for further study. The knowledge gained from this research study will bring us closer to our goal of finding the best possible treatment for our patients that will extend the length as well as improve the quality of their lives." Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is being evaluated in a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Clinical trials of Cloretazine(R) (VNP40101M) with temozolomide in brain tumors, and with stem cell transplantation in advanced hematologic malignancies, are also being conducted. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com. This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's potential inability to obtain regulatory approval for its products, particularly Cloretazine(R) (VNP40101M), delayed or unfavorable results of drug trials, the possibility that favorable results of earlier preclinical studies or clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, the inability to manufacture product, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forward-looking statements included under Item 1A, "Risk Factors" in Vion's Form 10-K for the year ended December 31, 2007. In particular, there can be no assurance as to the results of any of the Vion's clinical trials, that any of these trials will continue to full accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. COMPANY CONTACT: Vion Pharmaceuticals, Inc.
CONTACT: Alan Kessman, Chief Executive Officer, or Howard B. Johnson, Web site:
Nationwide Survey Shows Women With Osteoporosis Expect to be Active as They Age but are not Doing Enough to Stay 'Strong to the Bone'
Nationwide Survey Shows Women With Osteoporosis Expect to be Active as They Age but are not Doing Enough to Stay 'Strong to the Bone'
Lack of action prompts nationwide campaign to encourage better bone health PHILADELPHIA, May 8 /PRNewswire/ -- A new nationwide survey conducted by Harris Interactive of over 1,000 women with postmenopausal osteoporosis found that about one in three women had not currently been prescribed medication and more than half reported they do not know enough about this potentially serious disease.(1) The survey was released today by the American Medical Women's Association (AMWA), a leading national advocate for women's health made up of over 3,500 female physicians. Women surveyed also reported that they do not want to slow down as they age, yet nearly half believe they are not doing enough to maintain their physical health.(1) Fifty-seven percent of the respondents reported they do not consistently do weight-bearing exercise, such as walking or dancing, which helps to keep bones strong.(1) The lack of knowledge and action related to bone health revealed by the survey could have consequences(2) because one in two women older than 50 is predicted to break a bone due to osteoporosis in her remaining lifetime.(2) Fractures could be directly or indirectly responsible for potential pain and disability. To address the disconnect between women's expectations and actions, AMWA and Pam Peeke, M.D., an international health and fitness expert, have launched Strong to the Bone, a nationwide awareness campaign to urge better bone health and encourage women to take steps to avoid fractures. The campaign kicks off during the month of May, National Osteoporosis Awareness Month, and is sponsored by Novartis Pharmaceuticals Corporation. "More than 80 percent of the surveyed women diagnosed with postmenopausal osteoporosis feared loss of independence.(1) One bad break can have personal, social and economic consequences,(2)" said Diana Galindo, M.D., a geriatrician and immediate past president of AMWA. "The survey also shows a direct relationship between knowledge and action; those who are the most knowledgeable about postmenopausal osteoporosis are the most likely to follow a healthy diet, do regular weight-bearing exercise, and have regular bone density testing.(1)" To help women learn more about staying Strong to the Bone, the campaign website (www.strongtothebone.com) includes a five-minute assessment to help evaluate women's personal osteoporosis risk and provides recommendations for better bone health. "Women should take the online osteoporosis assessment to empower themselves with information that can help them keep their bones strong," said Dr. Peeke, author of the bestselling book, Fit to Live. "They should then use this knowledge to speak to their healthcare professional about a personalized treatment plan that may work best for them. There are postmenopausal osteoporosis treatments that can help to manage the condition effectively.(3)" Osteoporosis is a disease characterized by low bone mass and deterioration of bone structure resulting in reduced bone strength and increased risk of fracture, particularly at the hip, spine, and wrist.(2) About the Survey(1) The survey was conducted by Harris Interactive and commissioned by Novartis Pharmaceuticals Corporation in partnership with the American Medical Women's Association (AMWA), a leading national advocate for women's health made up of more than 3,500 female physicians. The survey was conducted online between February 28 and March 10, 2008. Of the 3,563 invitations delivered, a total of 1,539 responses were received, resulting in a 43 percent participation rate. Among those who responded, 1,010 completed surveys were received from respondents who met the screening criteria of being a U.S. postmenopausal woman aged 55+ diagnosed with osteoporosis. The data have been weighted to reflect age, race/ethnicity, education, region and household income. Propensity score weighting was also used to adjust for respondents' propensity to be online. The data include women from urban (29 percent), suburban (39 percent) and rural (32 percent) locales as well as from every region of the country. Highlights of survey results include: -- 30 percent of women diagnosed with postmenopausal osteoporosis About AMWA
About the Sponsor Novartis Pharmaceuticals Corporation is a New Jersey based pharmaceutical company that produces prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions. The company recently launched a treatment for postmenopausal osteoporosis. (1) Novartis Pharmaceuticals Corporation. Postmenopausal Osteoporosis Media Contacts Rebecca Mathis First Call Analyst:
CONTACT: Sarah Vellozzi of Fleishman-Hillard, +1-212-453-2477 (office), Web site: http://www.amwa-doc.org/
Growing a new organ (CNN Money)
Some 15,000 Americans are on a waiting list for a liver transplant, and it is a grueling - and ghoulish - vigil. Most organs available for transplant come from someone who has died in an accident. And more than 6,000 patients will die waiting for a transplant each year. [more]
Vion Pharmaceuticals to Appeal Nasdaq Delisting
Vion Pharmaceuticals to Appeal Nasdaq Delisting
Company to Request Hearing with Listing Qualifications Panel NEW HAVEN, Conn., May 8 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (NASDAQ:VION) today announced that it had received a letter, dated May 7, 2008, from The Nasdaq Stock Market Inc. (Nasdaq) stating that the Company's common stock will be delisted from the Nasdaq Capital Market as of the opening of business on May 16, 2008 because the Company does not comply with Marketplace Rule 4310(c)(3) which requires the Company to have a minimum of $2,500,000 in stockholders' equity, or $35,000,000 market value of listed securities, or $500,000 of net income from continuing operations for the most recently completed fiscal year or two of the three most recently completed fiscal years. The Company has the right to appeal the Nasdaq Staff determination to a Nasdaq Listings Qualifications Panel. If the Company requests a hearing no later than May 14, 2008, the request for a hearing will automatically stay the delisting of the Company's common stock until the Panel reaches a decision. The Company intends to request a hearing before May 14, 2008. There can be no assurance that the Panel will grant the Company's request for continued listing. Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is being evaluated in a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Clinical trials of Cloretazine(R) (VNP40101M) with temozolomide in brain tumors, and with stem cell transplantation in advanced hematologic malignancies, are also being conducted. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com. This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's potential inability to obtain regulatory approval for its products, particularly Cloretazine(R) (VNP40101M), delayed or unfavorable results of drug trials, the possibility that favorable results of earlier preclinical studies or clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, the inability to manufacture product, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forward-looking statements included under Item 1A, "Risk Factors" in Vion's Form 10-K for the year ended December 31, 2007. In particular, there can be no assurance as to the results of any of the Vion's clinical trials, that any of these trials will continue to full accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. COMPANY CONTACT: Vion Pharmaceuticals, Inc. Source: Vion Pharmaceuticals, Inc. CONTACT: Alan Kessman, Chief Executive Officer, or Howard B. Johnson, Web site:
BioCryst Reports First Quarter 2008 Financial Results and Clinical Update
BioCryst Reports First Quarter 2008 Financial Results and Clinical Update
BIRMINGHAM, Ala., May 8 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the quarter ended March 31, 2008. The Company reported revenues of $10.8M in the first quarter of 2008, compared to $9.2M in the first quarter of 2007. The net loss for the quarter ended March 31, 2008 was $13.1M, or $0.34 per share, compared to a net loss for the quarter ended March 31, 2007 of $8.8M, or $0.30 per share. Research and development (R&D) expenses were $21.9M in the first quarter of 2008, compared to R&D expenses of $16.2M in the first quarter of 2007. The increase is primarily attributable to costs associated with the advancement of clinical programs, the costs related to manufacturing lead drug candidates and the increase in personnel related costs, which included an increase in the non-cash share-based compensation charge. General and administrative (G&A) expenses for the first quarter of 2008 were $2.9M compared to G&A expenses of $2.4M for the same quarter in 2007. The higher G&A expenses were primarily due to an increase in professional fees and personnel related costs. As of March 31, 2008, the Company had cash, cash equivalents and investments of $81.2 million. "Our financial flexibility and stability will allow us to pursue all of the significant milestones we have set forth for our pipeline candidates," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "2008 will be a very active year in the clinic for BioCryst, and we are fortunate to have the financial basis to advance our drug candidates in order to deliver the greatest value to both patients and our shareholders." Recent Corporate Highlights Forodesine HCl cutaneous T-cell lymphoma (CTCL) trial update and chronic lymphocytic leukemia (CLL) trial initiation The forodesine HCl CTCL pivotal trial is enrolling as planned. This trial has been reviewed under a Special Protocol Assessment (SPA) from the United States Food & Drug Administration (FDA) to support regulatory approval. BioCryst has also initiated a second clinical trial for patients with CLL based upon data presented at the December 2007 ASH meeting, which demonstrated the potential of forodesine HCl as a treatment for CLL, both as a single agent and in combination with bendamustine. This second CLL trial is a single-arm study evaluating single agent forodesine HCl as a treatment for patients with CLL; response rate is the primary endpoint. The first patient was dosed during the first quarter 2008, and BioCryst will provide a trial update by year end. Intramuscular (i.m.) peramivir clinical development update BioCryst initiated a Phase III i.m. peramivir trial early this year and voluntarily discontinued it after 82 of the planned 600 patients had enrolled because of a decision to pursue higher doses in a Phase II setting. Patients with influenza A and B were treated with either placebo or 300mg of i.m. peramivir. Although only 14% of the planned patients were enrolled in the study, results supported the activity of 300mg peramivir. The study was designed to show a difference within the influenza A subgroup, where preliminary clinical data showed a 30 hour reduction in time to alleviation of symptoms in patients that received peramivir compared to those who received placebo. Preliminary results from the overall population showed a reduction in time to alleviation of symptoms of approximately 14 hours. Because the trial was not carried out to completion, the sample size was small; the observed treatment effect was not statistically significant. These results are consistent with data from previous clinical trials:
"We are encouraged by the signs of activity of i.m. peramivir and are prepared to move forward and evaluate a higher dose. The consistency seen between the results of our recent clinical trials gives us confidence that i.m. peramivir has the potential to be an effective treatment for influenza," stated Dr. Thomas J. Simon, Interim Chief Medical Officer. BCX-4208 development update Following review of a planned interim analysis of the ongoing Phase IIa trial of BCX-4208 in psoriasis, Roche has terminated its license agreement for the development of BCX-4208 for autoimmune diseases and transplant. As a result, BioCryst will regain worldwide rights to BCX-4208. Roche and BioCryst have agreed to complete the ongoing Phase IIa trial. The planned interim analysis showed that BCX-4208 was safe and well-tolerated; clinical efficacy was not demonstrated. The ongoing Phase IIa trial is a randomized, double blind, placebo controlled, dose ranging study in 66 patients with moderate to severe plaque psoriasis. BCX-4208 is administered once a day for 6 weeks at a dose of either 20mg or 120mg. The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetic profile of BCX-4208. Secondary objectives include assessment of pharmacodynamic measures and clinical response. The planned interim analysis of the Phase IIa trial included 30 patients divided evenly across the three study arms. The safety analysis includes follow-up on all 30 patients. Of the 30 patients evaluated for efficacy, 18 patients completed all 6 weeks of dosing. The 12 patients who discontinued prior to completing 6 weeks of dosing were equally distributed across the three arms of the study. In an ongoing Phase I multiple ascending dose study, BCX-4208 showed a dose response effect on reducing lymphocyte counts at doses up to 1040mg administered once daily for 7 days. Interim data from the ongoing Phase IIa study at 20mg and 120mg showed similar dose-dependant effects on reduction of peripheral blood lymphocyte counts. Affected lymphocyte subsets in the Phase II study included CD4+, CD8+, CD56+, and CD20+ cells. "While Roche's decision is disappointing, we are very encouraged by the effects on lymphocyte counts that we are seeing with BCX-4208. Similar activity with other experimental and marketed drugs has been associated with clinical efficacy in the treatment of various autoimmune diseases. Together with the good safety and tolerability profile of BCX-4208 observed to date, these data provide a strong scientific rationale for continuing to explore the activity of BCX-4208 in the treatment of autoimmune diseases," Mr. Stonehouse commented. "We look forward to evaluating the final data from the full cohort of 66 subjects later this year." Conference Call and Webcast The Company will sponsor a conference call at 8:30 a.m. Eastern Time on May 8, 2008 to discuss the financial results and the status of each of our programs in more detail. This call is open to the public and can be accessed live either over the Internet from www.biocryst.com or by dialing 1-800-860-2442 (U.S.). No passcode is needed for the call. About BioCryst BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The Company is advancing multiple internal programs toward potential commercialization including forodesine HCl in oncology, BCX-4208 in psoriasis and peramivir in seasonal and life-threatening influenza. BioCryst is collaborating with Mundipharma for the development and commercialization of forodesine HCl in markets across Europe, Asia, Australia and certain neighboring countries. In January 2007, the U.S. Department of Health and Human Services (HHS) awarded a $102.6 million, four-year contract to BioCryst to advance development of peramivir to treat seasonal and life-threatening influenza. In February 2007, BioCryst established a partnership with Shionogi & Co. to develop and commercialize peramivir in Japan. For more information about BioCryst, please visit the Company's web site at http://www.biocryst.com/. Forward-looking statements This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include that our belief that many subjects in the Phase II clinical trials of peramivir did not receive adequate dosing by intramuscular injection may not be correct, that HHS and the Food & Drug Administration (FDA) may not agree with our analysis, that HHS may further condition, reduce or eliminate future funding of the peramivir program, that the peramivir program may not be successful, that the pivotal trial with forodesine HCl in cutaneous T-cell lymphoma (CTCL) may not meet its endpoint, that the Phase II trial of BCX-4208 for psoriasis may not be successfully completed, that development and commercialization of forodesine HCl in CTCL may not be successful, that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed, that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates, that our product candidates may not receive required regulatory clearances from the FDA, that ongoing and future preclinical and clinical development may not have positive results, that we or our licensees may not be able to continue future development of our current and future development programs, that our development programs may never result in future product, license or royalty payments being received by BioCryst, that BioCryst may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or it may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of its product candidates, that our projected burn rate may not be consistent with our expectations, that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, most recent Registration Statement on Form S-3 (File No. 333-145638), Quarterly Reports on Form 10-Q, current reports on Form 8-K which identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements. BIOCRYST PHARMACEUTICALS, INC. Statements of Operations (Unaudited) Expenses: Total expenses 24,784 18,567 Loss from operations (14,016) (9,408) Interest and other income 918 583 Net loss $(13,098) $(8,825)
Balance Sheet Data (in thousands) Cash, cash equivalents and securities $81,166 $85,009
CONTACT: Stuart Grant, Senior Vice President, Chief Financial Officer of Web site:
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