Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Texas Biotech (TXB) -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (815)	7/6/2001 10:40:13 AM
From: keokalani'nui	Respond to of 834

Speedel Starts Human Testing With SPP 301, Its Endothelin A Receptor Antagonist BASEL, Switzerland, and BRIDGEWATER, N.J., July 6 /PRNewswire/ -- The Speedel Group, a cardiovascular and metabolic drug development company based in Basel, Switzerland, announced today the initiation of Phase I testing of SPP 301, an optimized endothelin A receptor antagonist. This first phase I study is based on a randomized, double blind, placebo-controlled design. Ascending oral doses of SPP 301 are to be given to healthy male volunteers and tolerability and drug levels are assessed. ``This first study with SPP 301 in man becomes possible only a few months after an exclusive option agreement was signed with Roche for this interesting development candidate,'' states Thierry Briand, M.D., Speedel's Project Director for SPP 301. ``Speedel has been able to complete within a few months all necessary pre-clinical activities, elaborate comprehensive documentation, establish the Phase I protocol and obtain the Ethical Review Committee approval, demonstrating again its fast-track development capabilities. Hence, we can start the first human study swiftly, and explore stepwise the potential of this compound in man.'' Alice Huxley, President and CEO commented: ``Initiation of the first human study with SPP 301 is a significant event for Speedel. It means that Speedel now has two compounds in active clinical and technical development: the oral renin inhibitor SPP 100, licensed from Novartis Pharma AG and brought by Speedel into Phase II, and SPP 301, an optimized oral endothelin A receptor antagonist from Roche, now promoted by Speedel into Phase I. In both cases, Speedel was able to honor the confidence received from its partners and translate its ambitious plans into action and progress.'' The clinical potential of combined (A and B) as well as of selective (either A or B) endothelin receptor antagonists is currently being evaluated by several pharmaceutical companies. Evidence from in vitro and animal testing, as well as from clinical studies suggests that endothelins may play a pivotal role in several cardiovascular diseases. Speedel has the opportunity to benefit from Roche's pioneering position in the research/drug discovery of selective and optimized endothelin receptor antagonists, and is excited to contribute to the clinical investigation and development of a selective endothelin A receptor antagonist. Speedel was established in 1998 in Basel, Switzerland, and focuses on the development of drugs for the treatment of cardiovascular and metabolic diseases.

To: keokalani'nui who wrote (815)	8/10/2001 3:44:02 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 834

Friday August 10, 3:13 pm Eastern Time Press Release SOURCE: Actelion Ltd FDA Advisory Committee Votes Unanimously to Recommend Approval of Tracleer for Treatment of Pulmonary Arterial Hypertension ALLSCHWIL, Switzerland--(BUSINESS WIRE)--Aug. 10, 2001--Actelion Ltd. (SWX:ATLN) today announced that the Cardiovascular and Renal Drugs Advisory Committee voted unanimously to recommend to the U.S. Food and Drug Administration (FDA) the approval of the oral dual endothelin receptor antagonist Tracleer(TM) (bosentan) for the treatment of pulmonary arterial hypertension (PAH). PAH is a life-threatening chronic condition that can severely compromise the function of the lungs and heart. While the FDA is not bound by the recommendation, it traditionally follows the Committee's advice. ``We will continue to work closely with the FDA to ensure that we can bring Tracleer, the first oral therapy for pulmonary arterial hypertension, to patients in an expeditious manner,'' said Jean-Paul Clozel, CEO of Actelion. ``The FDA Advisory Committee recommendation validates our belief in the therapeutic potential of endothelin receptor antagonism.'' The Committee based their recommendation to approve Tracleer on two successfully concluded pivotal trials, the larger of which is known as the BREATHE-1 (Bosentan: Randomized Trial of Endothelin Receptor Antagonist THErapy) trial. BREATHE-1 principle investigator Lewis Rubin, MD, Professor of Medicine and Director, Pulmonary and Critical Care Medicine, University of California at San Diego commented: ``We are nearing a milestone in the treatment of pulmonary arterial hypertension. For the first time, patients and their families can have realistic hope that an oral treatment demonstrating very promising results may soon be made available.'' In the 213-patient BREATHE-1 trial, twice-daily Tracleer (125 mg b.i.d. and 250 mg b.i.d.) demonstrated -- in both primary and secondary PAH -- statistically significant improvements versus placebo in the primary efficacy endpoint of the study, exercise capacity. The overall treatment effect for both doses of Tracleer combined was a 44 meter improvement in walking distance as measured by a six-minute walk test, compared to placebo (p=0.0002). Treatment with Tracleer also was associated with a significant delay in the time to clinical worsening as defined as death, hospitalization, worsening PAH or initiation of intravenous therapy (p=0.0015) and a significant improvement in functional status (p<0.05). Tracleer was well tolerated overall. In BREATHE-1, the incidence of liver enzyme elevations, defined as above three times the upper limit of normal (ULN), was 13 percent in the 125 mg b.i.d. group and 14 percent in the 250 mg b.i.d. group. These dose-related elevations were usually transient in nature and returned to normal in all patients upon dose-reduction or discontinuation. No patient in the 125 mg group discontinued treatment due to elevated liver enzymes, in contrast to three patients on 250 mg whose liver enzyme values returned to normal following permanent drug discontinuation. Approximately 100,000 people in the U.S. and Europe are afflicted with either primary pulmonary arterial hypertension or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus and HIV/AIDS and the use of certain appetite suppressants. The first signs of the disease, such as mild shortness of breath, fatigue and difficulty exercising, are so subtle that the disease is often either misdiagnosed or not diagnosed until the patient's condition is far advanced. The survival rate for PAH in untreated patients is only 40 to 55 percent at two years from the onset of symptoms. Once patients reach more advanced stages of PAH (WHO Class III and IV), they often have no choice but to go on prostacyclin therapy, which requires a 24-hour infusion pump and an intravenous line implanted through the chest directly into the patient's heart. Ultimately, many patients require lung transplantation. Actelion submitted a New Drug Application (NDA) for Tracleer in pulmonary arterial hypertension to the U.S. Food and Drug Administration in November 2000 and to the European Authorities in February 2001. Tracleer also is currently under review in Switzerland, Canada and Australia. U.S., European and Australian regulatory authorities have granted Tracleer Orphan Drug status in pulmonary arterial hypertension. The company is further studying Tracleer for children suffering from PAH, as well as the concomitant use of Tracleer in patients who receive intravenous prostacyclin therapy. Tracleer is currently also in Phase III trials for the treatment of chronic heart failure (CHF). Upon successful completion of this program, Genentech Inc. has the option to become a co-promotion partner for Tracleer in both indications (CHF and PAH) in the United States. Actelion Ltd, a biopharmaceutical company headquartered in Allschwil/Basel, Switzerland, is a leading player in creative science related to the endothelium -- the single layer of cells separating every blood vessel from the blood stream. Actelion concentrates on developing and bringing innovative drugs to patients. Tracleer(TM) and Veletri(TM) are in development for several cardiovascular disorders, including chronic and acute heart failure as well as pulmonary arterial hypertension. In addition, Actelion is conducting drug discovery programs in cardiovascular diseases, malaria, Alzheimer's disease and cancer. Actelion is quoted on the SWX Swiss Exchange (SWX New Market: ATLN). NOTE TO EDITORS: In the fifth paragraph, there is a ``less than'' symbol between (p and 0.05). This symbol may not appear properly in some systems. Contact: Actelion Ltd, Allschwil Roland Haefeli, +1 202 302 47 38