WKN 932790 !!! o. T.
ALLOS THERAPEUT (RTM/ECN)
Symbol: ALTH
Last Trade: 4.00 8:13AM ET
After Hours Change: N/A
Today's Change: 2.05 (105.13%)
Bid: 4.00
Ask: 4.05
(?)
- Additional Clinical Data Requested to Support Approval -
WESTMINSTER, Colo., June 2 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that it has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for RSR13 (efaproxiral) for the treatment of patients with brain metastases originating from breast cancer.
In the letter, the FDA indicated that before the NDA may be approved, it will be necessary for Allos to complete its ongoing Phase III clinical trial of RSR13 in patients with brain metastases originating from breast cancer and submit the results as an NDA amendment for the FDA's review. The ongoing Phase III trial, called ENRICH (ENhancing Whole Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases), will seek to enroll approximately 360 patients at up to 50 cancer centers across North America. In the letter, the FDA stated, "if the study shows effectiveness in this population (increased survival) using the pre-specified analysis, and the study is otherwise satisfactory, we believe it would, together with the subset result in RT-009, support approval".
No other specific deficiencies were noted in the approvable letter. However, the FDA indicated that additional general comments from Clinical Pharmacology, Pharmacology/Toxicology and Chemistry would be forwarded separately. The FDA also noted that it has not completed its inspection of the manufacturing and controls facilities listed in the NDA, which remains a prerequisite to approval of the NDA.
"We are pleased that the FDA has determined that RSR13 is approvable, assuming a favorable outcome of our ENRICH study," said Michael Hart, President and Chief Executive Officer of Allos. "We remain focused on completing the enrollment of the ENRICH study as soon as possible, and will continue to work with the FDA with the goal of advancing RSR13 toward approval."
About RSR13 (efaproxiral)
RSR13 (efaproxiral) is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors prior to radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy in the treatment of cancer. By increasing tumor oxygenation at the time of treatment, we believe RSR13 (efaproxiral) has the potential to enhance the efficacy of standard radiation therapy.
Oder hat jemand eine Seite , auf dem der Wert aufgefürht wird?
gruß
GS
02.06.2004 16:31:00
Die Allos Therapeutics Inc. erhielt von der US-Gesundheitsbehörde FDA eine bedingte Marktzulassung für sein Medikament RSR13 zur Behandlung von Patienten mit einem Gehirntumor, der sich von der Brust her ausgeweitet hat.
Voraussetzung für die endgültige Zulassung sei ein erfolgreicher Abschluss der laufenden Phase-III-Studie sowie eine befriedigende Inspektion der Produktionsanlagen.
Dieser FDA-Beschluss kam überraschend, da das Beratergremium der FDA keine Empfehlung für das Produkt ausgesprochen hat. Das Präparat war in einer Studie nicht erfolgreich, lediglich in einer Untergruppe der Probanten stellte sich ein Erfolg ein. Deshalb beantragte Allos nicht die Zulassung zur Behandlung von allgemeinem Gehirntumor, sondern nur für solchen Gehirntumor, der in der Brust entstanden ist.
greetz joker
Ich habe verstanden es handele sich um ein Präparat zu Behandlung von Brustkrebs!!
Wer aber Brustkrebst hat und dann noch einen Gehirntumor, da frage ich mich, welche Chance der noch hat??
gruß
gs
13:05 25.09.09
WESTMINSTER, Colo.--(BUSINESS WIRE)--
Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). FOLOTYN is the first and only drug approved by the FDA for this indication and represents a new treatment option for patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. Allos expects to make FOLOTYN available to patients in the U.S. in October.
http://www.ariva.de/news/...actory-Peripheral-T-cell-Lymphoma-3083927
Time Ex Price ChangeVolume
§
§08:36:17 Q 9.16 +1.01 200
§08:36:01 Q 9.17 +1.02 1,000
§08:36:01 Q 9.17 +1.02 200
§08:36:01 Q 9.17 +1.02 100
§08:36:01 Q 9.17 +1.02 200
§08:36:01 Q 9.17 +1.02 200
§08:35:56 Q 9.13 +0.98 200
§08:35:50 Q 9.15 +1.00 200
§08:35:50 Q 9.14 +0.99 100
§08:35:50 Q 9.14 +0.99 200
§
Bin zwar nicht dabei, aber trotzdem nett zu sehen.
mc
Recent Trades - Last 10
Time Ex Price Change Volume §
§08:51:27 Q 9.09 +0.94 100
§08:51:27 Q 9.09 +0.94 200
§08:51:26 Q 9.09 +0.94 100
§08:51:26 Q 9.09 +0.94 100
§08:51:25 Q 9.10 +0.95 100
§08:51:25 Q 9.10 +0.95 100
§08:51:25 Q 9.10 +0.95 500
§08:51:25 Q 9.10 +0.95 759
§08:51:22 Q 9.11 +0.96 400
§08:51:21 Q 9.11 +0.96 1,000
mc