Altus Pharmaceuticals Reports Last Patient Visit Of Trizytek(TM) Phase 3 Efficacy Trial.Trizytek Clinical Program Demonstrates Commitment to Advancing Enzyme Replacement Therapy Enzyme replacement therapy is a medical treatment replacing an enzyme in patients in whom that particular enzyme is deficient or absent. Usually this is done by giving the patient an intravenous (IV) infusion containing the enzyme. Options for Cystic Fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. Patients CAMBRIDGE, Mass. -- Altus Pharmaceuticals Inc. (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 : ALTU), a biopharmaceutical company focused on oral and injectable protein therapeutics for gastrointestinal and metabolic disorders, announced today the completion of the last patient visit of the Trizytek Phase 3 efficacy trial. In this trial, Altus is evaluating the efficacy of an oral, non-porcine enzyme replacement therapy for cystic fibrosis patients with exocrine pancreatic insufficiency Exocrine pancreatic insufficiency (EPI) is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. This disease is found frequently in dogs. EPI is also found in humans afflicted with cystic fibrosis. . Derived from recombinant technology, Trizytek [porcine-free enzymes] is a consistent, stable and pure combination of three active enzymes in a fixed-ratio that is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. "Completing the last patient visit of the Phase 3 efficacy trial marks an important milestone in the development of Trizytek. This news confirms that we are on track to report top-line Trizytek efficacy data in the third quarter of 2008," stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. "We are pleased to report that 134 patients completed the efficacy trial, of which approximately 30 percent were in the severe malabsorption malabsorption /mal·ab·sorp·tion/ (mal?ab-sorp´shun) impaired intestinal absorption of nutrients. mal·ab·sorp·tion n. Defective or inadequate absorption of nutrients from the intestinal tract. group, with baseline CFAs below 40 percent. We believe that both the total number of patients completing the trial and the number in the severe malabsorption group are consistent with the special protocol assessment that was discussed and agreed upon between Altus and the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ." The DIGEST trials - - Determining the efficacy and safety of an Innovative GastrointESTinal enzyme complex - - are Altus Pharmaceuticals' Phase 3 clinical program. The DIGEST efficacy trial tested a one capsule per-meal dosing regimen and will study fat, protein and carbohydrate absorption in cystic fibrosis patients with exocrine pancreatic insufficiency. In parallel with the efficacy trial, Altus is conducting a long-term safety study to evaluate Trizytek following one year of open-label treatment. Dr. Gemayel continued, "Our Phase 3 Trizytek clinical program is the largest and most scientifically robust ever conducted to evaluate the efficacy and safety of enzyme replacement therapy and it demonstrates our commitment to advancing enzyme replacement therapy options for both cystic fibrosis patients and others who suffer from pancreatic insufficiency pancreatic insufficiency A relative or absolute lack of pancreatic enzymes, a finding typical of cystic fibrosis. See Cystic fibrosis. ." Dr. Gemayel concluded, "Because of the uncertainties that exist with therapeutics that contain animal-derived ingredients, we believe there is a need, now more than ever, for new products that are derived from recombinant technology such as Trizytek." About Trizytek [porcine-free enzymes] Trizytek has the potential to be the first porcine-free enzyme replacement therapy for patients with pancreatic insufficiency. Pancreatic insufficiency is a condition that affects most cystic fibrosis patients, as well as many patients with chronic pancreatitis chronic pancreatitis Chronic relapsing pancreatitis GI disease Recurrent pancreatitis linked to alcohol abuse or hemochromatosis, which may worsen with time. See Pancreatitis. . In these diseases, a deficiency of pancreatic enzymes causes poor absorption of essential nutrients, which often leads to malnutrition, impaired growth and reduced survival. Trizytek is intended to replace missing digestive enzymes Digestive enzymes Molecules that catalyze the breakdown of large molecules (usually food) into smaller molecules. Mentioned in: Heartburn digestive enzymes with one capsule per-meal to promote and maintain proper digestion and growth in affected patients. Altus is developing Trizytek to enhance health outcomes by offering significant patient advantages such as improved and more consistent dosing that we expect will drive better long-term compliance. About The Current Pancreatic Enzyme Replacement Market The existing animal-derived pancreatic enzyme replacement products have been marketed since before the enactment of the Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. in 1938 and are not marketed under new drug applications, or NDAs, approved by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. , or FDA. In April 2004, the FDA issued a notice that manufacturers of existing pancreatic enzyme replacement products will be subject to regulatory action if they do not obtain approved NDAs for those products by April 28, 2008. In October 2007, the FDA issued an update to the 2004 notice and announced that it has extended the deadline for unapproved un·ap·proved adj. Not approved or sanctioned: an unapproved vaccine; an unapproved protest march. pancreatic enzyme drug products from April 28, 2008 to April 28, 2010, but only if the manufacturers have investigational new drug applications on active status on or before April 28, 2008 and have submitted NDAs on or before April 28, 2009. According to IMS Health, global prescription sales of existing pancreatic enzyme replacement products were approximately $858 million in 2007. About Altus Pharmaceuticals Inc. Altus Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders. The Company's website is http://www.altus.com. Trizytek[TM] is a trademark of Altus Pharmaceuticals. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Certain statements in this news release concerning Altus' business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements include, but are not limited to, those relating to our Trizytek clinical trials, including the expected time for reporting and filing of results, and the ultimate outcome or results in our Trizytek clinical trials and development program. Any or all of the forward-looking statements in this press release may turn out to be wrong. No forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in Altus' reports to the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2008. However, Altus undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. |
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