SangStat Announces Key Scientific and Clinical Trial Data Accepted for Presentation At Major Transplant Meetings; 20 Papers Including New Clinical Data On Thymoglobulin and Cyclosporine.MENLO PARK Menlo Park. 1 Residential city (1990 pop. 28,040), San Mateo co., W Calif.; inc. 1874. Electronic equipment and aerospace products are manufactured in the city. Menlo College and a Stanford Univ. research institute are there. 2 Uninc. , Calif.--(BW HealthWire)--April 29, 1998--SangStat, The Transplant Company(R) (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :SANG), announced today that 20 peer-reviewed, scientific and clinical papers from SangStat researchers, clinicians and co-investigators will be presented at the ASTP ASTP Apollo Soyuz Test Project ASTP Army Specialized Training Program ASTP Advanced Space Transportation Program (NASA) ASTP Association of European Science & Technology Transfer Professionals ASTP American Society of Transplant Physicians and ASTS ASTS American Society of Transplant Surgeons ASTS Aeromedical Staging Squadron ASTS Asbestos in Schools Tracking System ASTS Advanced Surveillance & Tracking System ASTS Advance Supplement Testing Systems, Inc. annual meetings to be held next month. Most of these papers describe the results of several studies utilizing SangStat's drug candidates, and advance the Company's position as a leader in transplantation research. The annual meetings of the American Society of Transplant Physicians (ASTP) and Transplant Surgeons (ASTS) are being held in Chicago, May 9-16 and are the principal scientific meetings for transplant professionals in the U.S. with attendance expected in excess of 3,000. The ASTP and ASTS follow a stringent peer-review process involving transplant physicians, scientists, and surgeons from leading transplant centers in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , for selecting papers for presentation at these meetings. Of 26 papers submitted by SangStat researchers, clinicians and co-investigators, 20 have been accepted of which 9 will be oral podium podium In architecture, a pedestal on a large scale. It may be any of various elements that form the base of a structure, such as the platform forming the floor and substructure of a Classical temple, a low wall supporting columns, or the structurally or decoratively presentations. Data on several product candidates and technologies will be presented including CYCLOSPORINE cyclosporine /cy·clo·spor·ine/ (-spor´en) a cyclic peptide from an extract of soil fungi that selectively inhibits T cell function; used as an immunosuppressant to prevent rejection in organ transplant recipients and to treat severe , THYMOGLOBULIN(R), CELSIOR(R) and ALLOTRAP(R) peptides. "We are very pleased to see that SangStat's scientific and clinical research has received this high degree of recognition from prominent members of the transplant community," said Philippe Pouletty, M.D. Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "It is this growing reputation for quality research and product candidates that is helping us establish collaborations for research, clinical trials and our Transplant Pharmacy, and build loyalty amongst our future customers." -0-
CYCLOSPORINE
i) SangStat investigators will make an oral presentation on the
first clinical trial results with the Company's proprietary
CYCLOSPORINE candidate, Sang-35, in liver transplant recipients.
The transplant community has emphasized the value of reproducible
bioequivalence data in different patient populations and liver
recipients offer a stringent model for evaluation of cyclosporine
pharmacokinetics.
ii) Results of an additional trial assessing cyclosporine metabolites
for Sang-35 and Neoral(R) will be reviewed in an oral podium
presentation. Cyclosporine metabolites are an important parameter
of drug clearance in patients. The Company continues to plan and
conduct trials in different populations of organ transplant
recipients, such as heart transplant and pediatric recipients,
and expects to present the results of these trials at future
scientific meetings.
iii) SangStat researchers are also presenting the first proof of
principle results with its novel home blood collection device,
CycloStat(TM), for CYCLOSPORINE blood level monitoring.
SangStat filed an application (AADA) for market clearance of its
Neoral-bioequivalent CYCLOSPORINE with the FDA in November, 1996 and
the application is now under late stage review at the agency. Neoral
is the leading formulation of cyclosporine, an immunosuppressive drug
used in human organ transplantation to prevent graft rejection.
Worldwide sales of Novartis' cyclosporines in 1997 are reported at
$1.3 billion.
Key presentations will include:
-- Comparative Pharmacokinetics of Sang-35 Cyclosporine Versus
Neoral(R) in Stable Adult Liver Transplant Recipients; Shi-Hui
Pan, et al., National Institute of Transplantation
-- Bioequivalence of Sang-35 and Neoral for Cyclosporine Metabolites
in Stable Renal Transplant Recipients; Rita R. Alloway, et al.,
University of Tennessee
-- Extraction and Quantification of Cyclosporine From Whole Blood
Samples Collected With the CycloStat(TM) Collection Device; Jeff
Regan, et al., SangStat Medical Corporation
THYMOGLOBULIN
i) New data on the long-term follow-up (mean 16.5 months, range
12-22 months) of the first U.S. double blinded trial evaluating
THYMOGLOBULIN (anti-thymocyte globulin, rabbit) vs. ATGAM(R)
(anti-thymocyte globulin, horse) for induction therapy, at the
time of transplant, to prevent acute graft rejection in kidney
transplant patients will be presented at the ASTP. The
presentation will include key results on graft and patient
survival as well as the longer-term follow-up of the earlier
reported endpoints of graft rejection, event free survival and
adverse events at 12 months.
ii) Twelve month results of SangStat's U.S. pivotal Phase III trial
at 28 centers with THYMOGLOBULIN for the treatment of acute
rejection episodes in kidney transplant recipients will also be
presented at the joint plenary session of the two meetings.
Based on the results of the induction trial, SangStat intends to
conduct further studies with THYMOGLOBULIN for the prevention of
rejection, as part of its development program for this new indication
in the United States. An application for market clearance of
THYMOGLOBULIN for the treatment of rejection is currently in late
stage review at the U.S. Food and Drug Administration (FDA).
Key presentations will include:
-- A Randomized Double Blinded Comparison of Thymoglobulin vs. Atgam
for Induction for Adult Renal Transplant Recipients; D. Brennan,
et al., Washington University, St. Louis
-- 12 Month Intent to Treat Analysis of the Double Blind Randomized
Multicenter Thymoglobulin vs. Atgam Trial for the Treatment of
Acute Rejection Following Renal Transplantation; E. Steve Woodle,
for the U.S. Multicenter Thymoglobulin Study Group
-- Correlation Between Banff Criteria and Outcome at 12 Months
Following Acute Rejection In Multicenter Randomized Trial; L.
Moore, et al., SangStat Medical Corporation
CELSIOR
This week SangStat completes patient enrollment in its North
American multicenter clinical trial comparing CELSIOR to the local
standard of care in heart preservation. In an oral presentation, a
principal investigator will review the study design and preliminary
results. Pending the final results of this study, a 510(k) will be
prepared for submission to the FDA later in the year.
Key presentations will include:
-- Prospective, Randomized Multicenter Trial Comparing Celsior to
Standard Cardiac Preservation Solutions; D. Vega, et al., Emory
University
ALLOTRAP PEPTIDES
SangStat continues to advance its development of the novel
ALLOTRAP peptides for the promotion of graft acceptance. Several
presentations focus on recent research into the mode of action of
these peptides and the rational drug design of improved peptides.
Key presentations will include:
-- Prolongation of Rat Allograft Survival Following Therapy With
Rationally Designed Immunosuppressive Peptides: Analysis of the
Mechanism of Action; Cristina Cuturi, et al., University of
Nantes
-0-
COMPLIANCE Earlier this month over 300 people attended the First International Symposium on Transplant Recipient Compliance held in Arlington, VA. A multidisciplinary group of transplant professionals, including physicians and surgeons Physicians and surgeons are medical practitioners who treat illness and injury by prescribing medication, performing diagnostic tests and evaluations, performing surgery, and providing other medical services and advice. , nurse coordinators and social workers, as well as transplant recipients made presentations on topics including: critical issues influencing transplantation compliance; measuring compliance rates in different transplant environments; impact of compliance on transplant outcomes; and intervention strategies for increasing transplant recipient compliance. SangStat was proud to support this meeting with an unrestricted educational grant. Co-chairman Robert S Robert, Henry Martyn 1837-1923. American army engineer and parliamentary authority. He designed the defenses for Washington, D.C., during the Civil War and later wrote Robert's Rules of Order (1876). Noun 1. . Gaston, M.D. has been invited to speak on The Impact of Patient Compliance in a satellite symposium on Risk Factors and Determinants of Long-Term Graft graft, in surgery: see transplantation, medical. graft In horticulture, the act of placing a portion of one plant (called a bud or scion) into or on a stem, root, or branch of another (called the stock) in such a way that a union forms and the Outcome at the ASTP annual meeting. His presentation will highlight some of the key issues that came out of this landmark symposium. "The ASTP and ASTS meetings are important forums for scientific exchange and dialog with members of the transplant community," said Philippe Pouletty, M.D. Chairman and CEO. He continued, "With our diverse research and clinical development programs, the growing number of centers participating in our Transplant Pharmacy Program, and the mounting anticipation of the potential near term approval of our two lead therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. , we continue to strengthen our reputation as The Transplant Company(R)." SangStat is a specialty pharmaceutical company applying a disease management approach to improve the outcome of organ transplantation The transfer of organs such as the kidneys, heart, or liver from one body to another. The transplantation of human organs has become a common medical procedure. Typical organs transplanted are the kidneys, heart, liver, pancreas, cornea, skin, bones, and lungs. . SangStat has a total of 12 monitoring and therapeutic product and product candidates to address the pre-transplant, acute care and chronic phases of transplantation. SangStat is in Menlo Park, California Menlo Park is a city in San Mateo County, California in the United States of America. It is located at latitude 37°29' North, longitude 122°9' East. Menlo Park had 30,785 inhabitants as of the 2000 U.S. Census. , and operates The Transplant Pharmacy(R), a comprehensive pharmacotherapy pharmacotherapy /phar·ma·co·ther·a·py/ (-ther´ah-pe) treatment of disease with medicines. phar·ma·co·ther·a·py n. Treatment of disease through the use of drugs. management program, and wholly-owned subsidiaries, SangStat Atlantique S Atlantique may refer to:
base air base, air station - a base for military aircraft army base - a large base of operations for an army in Nantes, France, SangStat Canada, Ltd. in Mississauga, Ontario For the First Nation, see . Mississauga (pronounced: [ˌmɪsɪˈsɑgə] listen , Canada and XenoStat, Inc., in Menlo Park, California. This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that involve risks and uncertainties. Forward-looking statements reflect SangStat's current views with respect to future events. Actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated. Important factors common to the regulatory review and approval process could cause actual results to differ materially with regard to the approvability and possible market acceptance of SangStat's finished CYCLOSPORINE drug product and THYMOGLOBULIN. These factors include, without limitation: (1) that data obtained from clinical trials are subject to varying interpretations, and there can be no assurance that the agencies (or the agencies' panel of experts) will agree with SangStat's assessment of clinical trial results or proposed labels; (2) that there can be no assurance that the agencies will not issue new guidelines, guidance documents, policies, or regulations or otherwise have new, different or previously unknown requirements that may materially affect the approvability of the products, (3) that there can be no assurance that final labeling can be agreed upon Adj. 1. agreed upon - constituted or contracted by stipulation or agreement; "stipulatory obligations" stipulatory noncontroversial, uncontroversial - not likely to arouse controversy in a timely manner; (4) that there can be no assurance that any manufacturing or control issues will be adequately resolved to the agencies' satisfaction; (5) that there can be no assurance that any current or future questions relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the FDA's review of the AADA AADA American Academy of Dramatic Arts AADA American Academy of Dermatology Association AADA Association for Adult Development and Aging AADA Australian Antique Dealers' Association AADA Abbreviated Antibiotic Drug Application AADA Academy of American Doll Artists , PLA (Programmable Logic Array) A type of programmable logic chip (PLD) that contained arrays of programmable AND and OR gates. PLAs are no longer used. See PLD. (language, music) Pla - A high-level music programming language, written in SAIL. or ELA Noun 1. ELA - an extreme leftist terrorist group formed in Greece in 1971 to oppose the military junta that ruled Greece from 1967 to 1974; a revolutionary group opposed to capitalism and imperialism and the United States Revolutionary People's Struggle applications or to the inspection of the THYMOGLOBULIN manufacturing facility can be adequately answered to FDA's satisfaction; and (6) that there can be no assurance of regulatory approval of either CYCLOSPORINE or THYMOGLOBULIN. Other factors that could cause actual results to differ materially include, without limitation, uncertainty related to the current or future manufacturing of commercial quantities of CYCLOSPORINE and THYMOGLOBULIN on commercially favorable terms, adequate and continuous supply of bulk CYCLOSPORINE drug substance, market acceptance, profitability, competition and potential litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . For a discussion of other factors that might result in different outcomes, see SangStat's 1997 Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , in particular "Risks Associated With CYCLOSPORINE" set forth therein, and the Company's filings on Forms 10-Q with the Securities and Exchange Commission. -0- You can find copies of our latest press releases on the web at www.biospace.com/sangstat. CONTACT: SangStat Maree Wall, 650/688-2331 (Investors) or BMC (BMC Software, Inc., Houston, TX, www.bmc.com) A leading supplier of software that supports and improves the availability, performance, and recovery of applications in complex computing environments. / Trout Brad Miles, 212/477-9007 x17 (Media) |
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