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GRAUENHAFT.
kann man vergessen.
Alternativ: man steigt 10% unter deren StopLoss erst ein...
so wie bei Hana heute!
SL bei 0,83, dann
Ziel 0,83 und SL bei 0,829
????
Sorry, aber kannst Du lesen?
es ist nun wirklich nicht damit getan, kurz "Verzeihung" zu schreiben, nachdem Du ganz bewußt hier Lügen platziert hast (Posting 172, 174 und 176). Es gibt keine solche Mitteilung im Aktionär! Also alles nur Lügen!
Du solltest gesperrt werden!
Nun endlich mal tolle Neuigkeiten, und zwar von der Studie, die Vincristine in Form von Marqibo an rückfälligen erwachsenen ALL-Patienten testet: Acht von 53 Probanden zeigen "complete remission", andere zumindest teilweise Rückbildung. Bei allen Patienten war eine Vincristine-Therapie vorher erfolglos geblieben. Ich denke, diese ermutigenden Zwischenergebnisse, das Bemühen, Marqibo auch gegen andere Krebsarten einzusetzen ( relativ neu: Aderhautmelanom, Phase II begonnen ) sowie, falls Marqibo reüssiert, die berechtigte Hoffnung auf beschleunigte Zulassung durch die FDA aufgrund des bereits verliehenen Orphan drug status des Medikaments wird jetzt Bewegung in die Aktie bringen.
Marqibo hat wegen seiner Alleinstellung für bestimmte Patientengruppen sowie seiner erhofften vielfältigen Einsatzmöglichkeiten vermutlich mehr Potential als das Anti-Brechmittel Zensana je hatte ( davon abgesehen: auch dessen Auslizensierung kann ja noch
Einkünfte bescheren ).
Ich war bei Hana sehr früh investiert, bin daher nicht allzuweit im roten Bereich und habe in den vergangenen Wochen nachgekauft, da ich einen dauerhaft noch niedrigeren Kurs als den momentanen für schlicht unmöglich halte: mindestens eine drug hat enormes Potential und beginnt nun auch endlich damit, dieses zu beweisen ( man sehe sich auf der Homepage übrigens nur mal die beteiligten Krankenhäuser und Universitäten an - Hausnummern! ).
Allen an HanaBiosciences verzweifelten wünsche ich jedenfalls schöne Feiertage - auf unseren kleinen Drugmaker aus Kalifornien bezogen werden diese womöglich bald anbrechen!
Date: 12/8/2007 9:00:00 AM
For a complete listing of our news releases, please click here
SOUTH SAN FRANCISCO, Calif., Dec. 8, 2007 (PRIME NEWSWIRE) -- Hana
Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on
strengthening the foundation of cancer care, presented results
today from both clinical and non-clinical studies of Marqibo(r)
(vincristine sulfate injection, OPTISOME(tm)) at the 49th Annual
Meeting of the American Society of Hematology (ASH). In an oral
session, Deborah A. Thomas, M.D. from the University of Texas M. D.
Anderson Cancer Center presented clinical data showing that Marqibo
with or without pulse dexamethasone appears to have clinically
meaningful activity in heavily pre-treated adults with Acute
Lymphoblastic Leukemia (ALL).
Dr. Thomas presented publication No. 858, "Safety and Efficacy of
Marqibo (Vincristine Sulfate Liposomes Injection, OPTISOME(tm)) for
the Treatment of Adults with Relapsed or Refractory Acute
Lymphoblastic Leukemia (ALL)." during the session entitled Acute
Lymphocytic Leukemias: Therapy, excluding Transplantation.
Data from two clinical trials were integrated for the presentation:
a Phase 2 trial of single agent Marqibo given at 2 mg/m2 (no dose
capping) every two weeks; and a multi-center dose-escalation Phase
1 trial of Marqibo in combination with pulse dexamethasone
administered on a weekly schedule. In total, 52 adult patients with
relapsed or refractory ALL were treated in the two studies
combined, and all patients had previously received and failed
conventional vincristine containing therapy. There were no
restrictions on the number of prior therapies. Out of the 52
patients, eight complete remissions and three partial remissions
were observed for an overall response rate of 21 percent. An
additional 12 patients (23 percent) achieved hematological
improvements such as clearance of marrow blasts and platelet
transfusion independence. Five responders were able to undergo
allogeneic stem cell transplantation following therapy with
Marqibo. The maximum-tolerated dose was established in the Phase 1
trial as 2.25 mg/m2 without dose-capping.
"The data presented today by Dr. Thomas provides support and
validation for our ongoing rALLy study, a Phase 2
registration-enabling clinical trial of single-agent Marqibo in
adults with ALL in second relapse," stated Steven R. Deitcher,
M.D., President and CEO of Hana Biosciences. "Marqibo has
demonstrated clinical benefit among an extremely sick patient
population for whom there is no approved treatment regimen. We are
pleased to be working with outstanding clinical investigators to
advance this promising new agent."
Hana Biosciences also presented non-clinical data for Marqibo
during the Lymphoma: Pre-Clinical: Chemotherapy and Biologic
session under publication No. 1403, "Marqibo (Vincristine Sulfate
Liposomes Injection, OPTISOME(tm)) Concentrates Vincristine in
Tumor Tissue and Lymphoid Malignancy Oriented Tissues in
Tumor-Bearing Mice." The study showed that Marqibo's
Optisome(tm)-encapsulation of vincristine resulted in targeted
delivery and concentration of vincristine in tumor tissue, bone
marrow, lymph nodes, liver and spleen, and maintenance of
significant tissue drug concentrations for an extended period of
time compared to conventional vincristine. Specifically, lymphoid
malignancy-oriented tissue and intra-tumor vincristine
concentrations were greater in Marqibo-treated mice compared to
conventional vincristine-treated mice resulting in greater
vincristine exposure. Marqibo administration resulted in a
three-fold increased concentration of vincristine in bone marrow at
48 hours and maintained significant tissue concentrations for
several days compared to conventional vincristine. The ability of
Marqibo to target these tissues and organs makes it particularly
attractive as a treatment for hematologic malignancies such as
leukemia, myeloma and lymphoma.
SOUTH SAN FRANCISCO, Calif., Feb. 12, 2008 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the company has completed patient enrollment in its Phase 1 dose-escalation clinical trial of Alocrest(tm) (vinorelbine liposomes injection, OPTISOME(tm)). This trial was designed to assess the safety, tolerability and preliminary efficacy of Optisomal encapsulated vinorelbine, or Alocrest. Preliminary results show that Alocrest was generally well tolerated with acceptable and predictable toxicities and had a maximum tolerated dose comparable to that of un-encapsulated vinorelbine. In this first human study of Alocrest, the drug produced a disease control rate of 46 percent across a broad range of doses and tumor types. Hana Biosciences anticipates submitting these data for presentation at a major medical conference in Europe this summer.
"We are pleased to have achieved this milestone in the clinical development of our second Optisome-encapsulated product candidate. In this Phase 1 clinical trial, Alocrest was well-tolerated and showed promising anti-tumor activity with no new toxicity relative to conventional vinorelbine," said Steven R. Deitcher, M.D., President and CEO of Hana Biosciences. "We are also encouraged to see such positive response data in heavily pre-treated patients. With these data in hand, we believe we are well positioned to seek out an enthusiastic partner with whom we can advance Alocrest as we focus our near-term efforts on the clinical development of Marqibo and Menadione."
The Phase 1 clinical trial enrolled adult subjects with confirmed solid tumors refractory to standard therapy or for which no standard therapy was known to exist, or with relapsed and/or refractory non-Hodgkin's lymphoma. Patients received Alocrest via a 60-minute IV infusion on days 1 and 8 every 21 days at various dose levels. Reversible neutropenia was the most common dose limiting toxicity. The study was conducted at the Cancer Therapy and Research Center and the START facility in San Antonio and McGill University, Montreal.
Marqibo Currently in Phase 2 Clinical Trial for Metastatic Uveal Melanoma
SOUTH SAN FRANCISCO, Calif., June 30, 2008 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) for the treatment of adult patients with metastatic uveal melanoma. Orphan drug designation offers significant benefits to Hana Biosciences, including financial incentives and market exclusivity for a period of seven years.
"We are pleased to have received orphan designation from the FDA for Marqibo in metastatic uveal melanoma, a cancer with a clear unmet medical need. We believe this recognizes the need to pursue these difficult disease indications," said Anne E. Hagey, M.D., Vice President and Chief Medical Officer. "We look forward to working with the Agency on our ongoing program in uveal melanoma to find a safe and efficacious therapy that can help these patients."
Fast-Track-Status für Marqibo jetzt auch bei Patienten mit Aderhautmelanom
Hana is currently conducting a Phase 2 clinical trial to assess the efficacy of Marqibo as determined by Disease Control Rate (complete response (CR), partial response (PR), durable stable disease) in patients with metastatic malignant uveal melanoma. Secondary objectives are to assess the safety and anti-tumor activity of Marqibo as determined by response rate (CR, PR), progression-free survival, and overall survival. The patient population is defined as adults with uveal melanoma and confirmed metastatic disease that is untreated or that has progressed following one prior therapy. The Phase 2 trial is currently being conducted at the University of Texas MD Anderson Cancer Center.
SOUTH SAN FRANCISCO, Calif., July 14, 2008 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the European Commission has granted orphan medical product designation to Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) for the treatment of adult acute lymphoblastic leukemia (ALL). This designation was granted based on the recommendation of the European Medicines Evaluation Agency (EMEA) following a positive opinion from the Committee for Orphan Medicinal Products.
Orphan designation in the European Union offers significant benefits to Hana Biosciences, including market exclusivity for a period of ten years, financial incentives such as fee reductions or exemptions, EMEA scientific advice on product development, and direct access to the EMEA centralized procedure for the application for marketing authorization.
"Receipt of orphan designation for Marqibo from the European Commission reinforces the importance of developing novel medicines for the treatment of rare disease indications such as ALL," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We look forward to working with the EMEA on the future development of Marqibo for patients with relapsed leukemia who currently have few treatment options."
Hana Biosciences is currently enrolling patients in its registration-enabling Phase 2 "rALLy" clinical trial of Marqibo in patients with relapsed ALL. The company expects to report a futility analysis from the Phase 2 trial during the second half of 2008. Hana has received orphan drug and fast track designations for Marqibo for the treatment of ALL from the U.S. Food and Drug Administration.