Arqule (903396)..auch eine Perle wie psivida?
Es bleibt einem nichts anderes übrig als die definitiven Resultate der Phase 1 abzuwarten. Erste Aussagekräftige Resultate werden wohl erst mit der Phase 1a/2 kommen.
Das positive war, dass Roche ziemlich stark hinter Arqule steht. Die 15Mio $ werden Anfang nächstes Jahr also mit grosser Wahrscheinlichkeit ausbezahlt. Somit sinkt die Cash-Burn-Rate fast auf Null.
Sieht gut aus der Verlust pro Aktie wahr auf 0.52-0.56$ geschätzt für dieses Jahr und wird nun auf auf 0.35-0.38$ gesenkt. Das letzte Quartal hat es Arqule geschaft positiv abzuschliessen. Arqule sitzt immer noch auf 76Mio $ Cash.
Was auch immer, ist natürlich schön solche Zahlen zu sehen, aber ARQ501 wird es entscheiden. Kurz vor Jahresende startet die Phase 1b für die Combo-Trial ARQ501 und Gemcitabine. Nach erreichen der maximal erträglichen Dosis, wird die Phase 2 starten.
07:54 ARQL ArQule upgraded to Buy from Hold at Legg Mason (4.25 )
Legg Mason upgrades ARQL to Buy from Hold, as they believe that continued development of the co's E2F oncology program is a likely catalyst for share appreciation in the near-term. During the previous qtr, ARQL presented interim phase 1 data for ARQ 501, the co's only clinical cancer program, and they note that the co had previously formed a strategic alliance with Roche regarding this program. Importantly, there are initial signs of clinical activity, which given the evaluable patients' profile, is encouraging. Firm also notes other additional pipeline products, most notably ARQ 550RP (next generation ARQ 501), ARQ 650RP (non-E2F oncology program), and SIM-916 (in Phase I testing at Wyeth for rheumatoid arthritis).
http://secfilings.nasdaq.com/...pe=10%2DQ&RcvdDate=11%2F9%2F2004&pdf=
irgendwie wollte der Link nicht, darum halt noch so.
Der nächste Meilenstein wird die die Zahlung von 15Mio$ von Roche sein, die im Januar erwartet wird.
Als nächstes sollten die P1-Daten von ARQ-501 veröffentlicht werden, was im Frühling erwartet werden kann.
Nun das much-entscheidende werden dann die Daten aus den Combo-Trials sein. Wann die zu erwarten sind, weiss ich aber noch nicht.
Arqule liegt immer noch im Plan und wenn in den Combo-Trials die präklinischen Daten bestätigt werden, dann ist viel, viel Luft nach oben.
Wie aussagekräftig die P1-Daten sein werden, hängt davon ab, wie hoch die Dosen waren. Wurden genug Patienten mit den Dosen behandelt, bei welchen die Wirkung erwartet wird, kann eine Aussage gemacht werden. Wenn nicht muss man auf die Combo-Trials warten.
Dank diesen Meilensteinzahlungen kann Arqule nahe dem Breakeven forschen und die neuen Programme (Krebs) realisieren.
LINK
01-20-05 05:13 PM EST |
/PRNewswire-FirstCall/ -- ArQule, Inc. (Nasdaq: ARQL) is pleased to announce the appointment of Mr. William Messenger to its Board of Directors, effective immediately. Mr. Messenger brings a strong background in business leadership, strategy development and corporate governance. His business experience includes sales and marketing with IBM Corporation, and consultancy at McKinsey & Co. More recently he held senior positions at Advance Metabolic Systems. He is currently Managing Director of Lexington Sycamore Group, providing strategic consulting services to healthcare organizations, and is Director of the Mockler Center for Faith and Ethics in the Workplace at Gordon-Conwell Theological Seminary in Massachusetts.
Mr. Messenger holds a Bachelors degree in Physics from Case Western Reserve University, an MBA from Harvard Business School, and Masters degree in Divinity from Boston University.
"I am delighted to welcome Will Messenger to our Board of Directors," said Dr. Stephen A. Hill, ArQule's President and Chief Executive Officer. "His background and interest in strategic leadership, corporate governance and workplace ethics will match ArQule's strong commitment in these areas and will compliment the contribution of our current Board."
"ArQule is an exciting company with excellent people and technologies," said Mr. Messenger. "I am really pleased to have a chance in this role to help the company make a difference in people's lives."
About ArQule
ArQule, Inc. is a biotechnology company engaged in research and development of next-generation small-molecule cancer therapeutics based on its innovative Activated Checkpoint Therapy(SM) (ACT(SM)) platform. ACT(SM) compounds are intended to improve the way cancer patients are treated because they selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints that are defective in cancer. In addition to advancing its own programs, ArQule continues to advance the drug discovery efforts of pharmaceutical collaborators by providing high-quality library design and compound production, including collaborations with Pfizer and Novartis. For more information, please visit http://www.ArQule.com.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, which provides a safe harbor for forward-looking statements made by or on behalf of ArQule. Actual results may differ materially from those projected in the forward-looking statements or historical performance due to numerous risks and uncertainties that exist in ArQule's operations, development efforts and the business environment, including without limitation: the ACT(SM) platform may not improve efficacy or reduce toxicity and compounds resulting from the platform may not operate as intended; the preclinical efforts associated with the ACTSM pipeline may fail or prove disappointing; collaborators may terminate their agreements with ArQule because ArQule may fail to satisfy the collaborators' needs or for other reasons; and, the risks and uncertainties described in ArQule's Form 10- Q filed with the Securities and Exchange Commission on November 9, 2004, its Form 10-Q filed with the Commission on August 4, 2004, its Form 10-Q filed with the Commission on May 7, 2004 and its Form 10-K filed with the Commission on March 12, 2004. The forward-looking statements contained herein represent the judgment of ArQule as of the date of this report. ArQule disclaims any intent or obligation to update any forward-looking statement except to the extent required by law. SOURCE ArQule, Inc.
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Habe lange Zeit gemeint ich sei noch der einzige der In ARQ ist, bis sich plötzlich Saku wieder gemeldet hat mit einem Eintrag. Bin natürlich erfreut, dass es noch andere gibt.
Lest ihr auf Yahoo auch mit? Bin erfreut über die Qualität der Infos die man dort bekommt.
Habt Ihr das mit der Aktienplatzierung bei Institutionellen mitbekommen? Habe zuerst nicht so geschnallt um was es geht. Nun weiss ich es aber.
Heute werden Aktien im Wert von 30Mio $ bei Institutionellen platziert.
der Ausgabepreis ist 5.25$ also unter dem jetzigen gehandelten Wert.
Arq hatte schon Ende 2003 das Recht eingeräumt in den nächsten zwei Jahren (ab Ende 2003) Aktien im Wert von 50Mio $ zu platzieren. Die Aktien werden nicht im freien Handel übergeben sondern direkt den Instis übergeben. Als Vermittler tritt J.P. Morgan auf.
Die Leute auf Yahoo sind sich nicht so einig ob dies nun positiv oder negativ zu werten ist. Nun ich meine das die Verwässerung nicht so gross ist. Letztendlich entscheidet sowieso das Krebs-Programm. Und wenn das erfolgreich ist spielt diese minimale Verwässerung keine grosse Rolle.
Was mich positiv stimmt ist, dass überhaupt Instis einsteigen wollen, dies zeigt doch eine gewisse Glaubwürdigkeit gegenüber dem Produkt.
Arq hat nach der Ausgabe der Aktien Cash-Reserven von 113Mio $. Von soviel können die meisten Bio-Techs nur träumen und die Cash-Burn-Rate ist nahe dem Nullpunkt mit den Zahlungen von Roche.
Lasst uns also hoffen, dass ARQ-501 hält was es verspricht.
Nun noch zum Zeithorizont der ist doch sehr, sehr long. Ich weiss jetzt nicht mehr genau wie lange es gehen würde bis ARQ-501 eingeführt werden könnte. Ich meinte es seien 4-6 Jahre. Es bleibt also noch viel Zeit.
Einer auf Yahoo meinte auch es sei im Moment noch zu früh um investiert zu sein, man habe noch genug Zeit billig einzusteigen. Ich meinerseits bleibe aber drinnen solange die Erfolgsaussichten für ARQ-501 intakt sind.
Was mich noch beunruhigt hat, war das Anzeichen dass sich wieder Shorts an ARQ interessieren. Wir sahen ja was sie über den Sommer anrichteten.
Also dann wünsche uns viel Glück und gute Phase 1 Ergebnisse.
Greets Haschi-Baschi
WOBURN, Mass., May 16 /PRNewswire-FirstCall/ -- ArQule, Inc. (Nasdaq: ARQL - News) presented interim results for the ongoing phase 1 monotherapy trial of ARQ 501 at the annual meeting of the American Society of Clinical Oncology ("ASCO"). The data were presented by the Principal Investigator of the study, Dr. Geoffrey I. Shapiro of the Dana-Farber Cancer Institute/Harvard Medical School, and Dr. Chiang J. Li, ArQule's Chief Scientific Officer. Data reflects trial status as of March 24th, 2005.
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The poster presentation reports interim results that demonstrate clinical tolerability, favorable pharmacokinetics, and evidence of anti-tumor activity of ARQ 501 in patients with advanced solid tumors who had failed chemotherapy. Out of 16 patients who are evaluable for efficacy, 62.5% showed either tumor regression (1 partial response, 2 minor responses) or disease stabilization (7 patients).
"These results are very encouraging. With this update we have demonstrated further evidence of anti-cancer activity for ARQ 501 with an acceptable safety profile. We continue to experiment with dosing regimens in order to define the optimal regimen for ARQ 501," said Dr. Stephen A. Hill, ArQule's President and Chief Executive Officer.
ARQ 501 works through direct activation of checkpoint pathways, in a process known as ACT(SM). The phase 1 monotherapy study was designed to determine the clinical tolerability, recommended phase 2 dose and pharmacokinetics, when given intravenously to patients with advanced metastatic solid tumors. As of March 24, 2005, the study had enrolled a total of 32 patients who had failed prior regimens of chemotherapy, ranging from 1 to 15 courses per patient. Of the 26 patients who were evaluable for pharmacokinetic analysis, 20 patients had received ARQ 501 as a 1 hour infusion and 6 patients had received ARQ 501 on different infusion regimens. Adverse events have been mild or self-limited. Hemolytic anemia and hyperbilirubinemia were noted as drug-related serious adverse events, which were transient and clinically manageable.
Tumor evaluations were performed per RECIST criteria at study week 8 and every subsequent eight weeks. Evidence of anti-tumor activity was observed in 10 out of 16 (62.5%) evaluable patients as of March 24, 2005. This included 1 patient with a partial response (greater than 30% tumor reduction), 2 patients with minor responses, and 7 with disease stabilization ranging from 8 to 32 weeks. The partial response was observed in a sarcoma patient who has been on study for one year and eight months. The minor responses were seen in a patient with metastatic parotid cancer (21% reduction at 14 weeks) and a patient with metastatic adrenal carcinoma (18% reduction at 19 weeks). The patient with metastatic adrenal carcinoma remains on therapy.
The ARQ 501 monotherapy trial continues to enroll patients in dosing ranges of between 390 and 550 mg/m2, with infusion times between 1 and 3 hours. Once the optimal infusion time is identified, the maximal tolerated dose will be determined through dose escalation.
"Our goal is to reduce the overall risk and time involved in clinical development, rather than rushing into determining a maximum tolerated dose, as might be done for chemotherapeutic agents. We would like to complete Phase 1 with an optimized dosing regimen and biomarkers for patient selection in our intended phase 2 studies," said Chiang J. Li, MD. "The encouraging clinical activity and our deep scientific understanding of ARQ 501 allow us to work towards this high goal."
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Ne hab nicht verbilligt. Bin schon mit genug Kohle in ARQL.
Werde diese auch dort liegenlassen für eine Weile. Habe leider nicht so viel Zeit
um mich über den Markt zu informieren und alternative Investitionen zu suchen.
ARQL sieht immo sehr vielversprechend aus, auch wenn es noch länger dauern dürfte,
bis sich etwas produktives daraus ergiebt.
Gruss HaschiBaschi
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WOBURN, Mass., Jul 18, 2005 (BUSINESS WIRE) -- ArQule, Inc. (Nasdaq: ARQL) today announced that the direct activation of the human checkpoint kinase 2 (Chk2) caused the death of cancer cells and inhibited their growth and proliferation, as demonstrated in a study published in Cancer Research ("Dual Induction of Apoptosis and Senescence in Cancer Cells by Chk2 Activation: Checkpoint Activation as a Strategy Against Cancer," July 15, 2005).
Researchers in this study demonstrated that Chk2 activation in the absence of chemotherapeutic activity led to the death of cancer cells, thus defining the independent role of Chk2 activation in this process. Previously, researchers had hypothesized that the inhibition of checkpoints enhanced the effects of DNA-damaging chemotherapy on cancer cells. In contrast, this study showed that the activation of checkpoint mechanisms independently and directly led to the apoptosis, or programmed cell death, as well as to the senescence, or ageing, of cancer cells. This finding further demonstrates the potential of checkpoint activators as a novel class of anti-cancer agents with improved efficacy and safety.
"We are excited about these results, as they clearly support the exploration of direct checkpoint activation as a novel strategy in the discovery and development of targeted cancer therapeutics," said Dr. Stephen A. Hill, president and chief executive officer of ArQule. "These data provide additional scientific validation of checkpoint activation, which is the central focus of the Company's proprietary approach to oncology drug discovery and the basis for the ongoing clinical testing of ARQ 501, our partnered program with Roche."
The Cancer Research study is consistent with recent scientific publications in Nature (2005 April 14; 434 (7035): 907-13 and 2005 April 14; 434 (7035): 864-70). These publications present evidence from experiments in human tumors showing that cancers are the results of under-functioning checkpoints. ArQule's Activated Checkpoint Therapy(SM) (ACT) platform is designed to address these fundamental defects in human cancers.
Checkpoint activation pathways are dysfunctional but present in a broad spectrum of cancer cell types. ArQule's fundamental approach to treating cancer is to restore the natural biological function of these checkpoints and thereby to kill cancer cells selectively while maintaining the integrity and function of healthy cells, thus avoiding the undifferentiated damage caused, for example, by chemotherapy or radiation.
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Seit dem letzten Kommentar hat der Wert das 52Week top gemacht und ist nun wieder um einiges zurückgegangen. Von der Infoseite her sind folgende Sachen passiert:
- Die Immobilien wurden verkauft, hat einiges Geld in die Kassen gespühlt (weiss die Zahlen nicht mehr)
- vor kurzem (ca. 1 1/2 Wochen) hat Arqule das profitable Chemiegschäft abgestossen. Dies ohne update auf die Trials zu geben. Was doch vermuten lässt, das die Herren Verantwortlichen einiges mehr wissen.
- auf der Website von arqule sind die Phasen 1/1b abgeschlossen link. Von der ofiziellen Seite wurde noch nichts erwähnt.
- Die Meilensteinzahlung von Roche wurde noch nicht ausgeführt
- Der Anteil der Institutionellen in der Aktie ist gestiegen.
Die Informationspolitik von Arqule ist von mir ausgesehen ziemlich defensiv. Was mir aber eigentlich egal ist, da ich auf ein erfolgreiches ARQ-501 spekuliere. Im Moment sieht alles gut aus. Die länge der Trials sollte auch nicht beunruhigen, je länger ein Trial geht desto wahrscheinlicher ist, dass kiene krassen Nebenwirkungen aufgetretten sind. Arqule macht den eindruck eines kontinuierlichen, leisen Arbeiters. Man darf aber immer noch nicht vergessen, dass Arqule ein Gamble auf den Erfolg ihrer Pipeline ist.
Greets Flo
Am 9. November sind tatsächlich vielversprechende Resultate aus den 1B-Trials gekommen (Kombi-Trial 501-docetaxel).
Nun das Medi ist immer noch voll auf Kurs, der Aktienpreis ziemlich tief für die Erfolgsaussichten. Auf dem Yahoo-Forum wurden schon verschiedene Erklärungsversuche gemacht warum das so ist. Vorallem die defensive Info-Politik und die Unbekantheit des Wirkstoffes von ARQ-501 wurden als Hautpgründe genannt.
Wenn aber alles gut und wir bis Phase 3 durchhalten besteht Chance auf einen Blockbuster. Ist aber immer noch ein weiter Weg bis dort. Finanzierung der Phase 2 und 3 ist dank Roche gesichert.
ArQule Initiates Phase 1 Trial with ARQ 171, Provides Enrollment Update on ARQ 501 and ARQ 197
Wednesday December 6, 7:00 am ET
WOBURN, Mass.--(BUSINESS WIRE)--ArQule, Inc. (NASDAQ: ARQL - News) today announced the enrollment and successful dosing of the first patient in a Phase 1 clinical trial with ARQ 171, a second-generation compound generated through its Activated Checkpoint Therapy(SM) (ACT) program. Phase 1 data from this compound, together with Phase 2 data from the ongoing ARQ 501 program, will form the basis of a future licensing decision by Hoffmann-La Roche (Roche). As previously communicated, Roche has an option to ArQule's E2F-1 program in the field of cancer therapy.
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ArQule also updated progress in its other clinical programs. These include three Phase 2 trials with the first-generation E2F-1 compound, ARQ 501, as monotherapy in leiomyosarcoma and head and neck cancer, and as combination therapy with gemcitabine in pancreatic cancer, as well as a Phase 1 trial with ARQ 197, a proprietary, orally administered small molecule inhibitor of the c-Met receptor tyrosine kinase.
Phase 1 Trial With ARQ 171
The population in this open label, dose escalation trial will consist of patients with advanced solid tumors. The primary objective of the trial is to determine the safety, tolerability and maximum tolerated dose of ARQ 171. Secondary objectives are to determine the pharmacokinetic profile and to assess the preliminary anti-tumor activity of the compound.
"Initiation of Phase 1 clinical testing with ARQ 171 marks the achievement of a significant corporate milestone for this year," said Dr. Stephen A. Hill, president and chief executive officer of ArQule. "ARQ 171, which entered and completed GLP toxicology testing earlier this year, is the result of our biological insights into DNA damage response pathways and our capabilities in small molecule chemistry and intelligent drug design."
The first patient in the ARQ 171 trial was dosed at Premiere Oncology (Santa Monica, CA), where the principal investigator is Dr. Lee Rosen. Additional investigators and sites include Dr. Geoffrey Shapiro at Dana Farber Cancer Institute (Boston, MA) and Dr. Casey Cunningham at Mary Crowley Medical Research Center (Dallas, TX). Each of these investigators has been involved with ArQule's development of compounds that target the E2F-1 biological pathway to treat cancer.
ARQ 501 Program Update
With respect to the Phase 2 clinical program with ARQ 501, patient enrollment has been completed in the leiomyosarcoma trial. In the head and neck cancer trial, approximately 45 patients have been enrolled toward the total target number of 53 patients, and in the pancreatic cancer trial, approximately 55 patients have been enrolled toward the total target number of 66 patients. Assuming that recruitment continues at the current levels, ArQule anticipates completion of recruitment into its Phase 2 program (i.e. all three studies) before year-end. Based on the protocol-defined end-points, initial safety and efficacy data from these studies would be available by the middle of 2007.
ARQ 197 - c-Met Inhibitor Program Update
Patient recruitment is also continuing in the Phase 1 dose escalation trial with ARQ 197. Thirty-six patients have been treated with ARQ 197, at doses ranging from 20 to 360 milligrams per day. Based on current estimates, ArQule anticipates choosing a recommended Phase 2 dose for this compound by year-end and beginning initial Phase 2 exploration in early 2007.
Preliminary data from this trial was recently presented at the EORTC-NCI-AACR meeting in Prague. These data included highly encouraging signs of activity with minimal side effects.
"I am delighted with the rapid progress to date for our c-Met inhibitor," said Dr. Hill. "The level of interest in this pathway is increasing rapidly, and ARQ 197 has the potential to be the leading clinical stage compound against this target."
Ist explodiert, im Moment mit extrem hohes Volumen, kann das ganze aber nicht einschätzen, da Arqule in der Vergangenheit doch immer Spielball der Shorties war und vom Markt eigentlich nicht so beachtet wurde. Wär natürlich schön wenn der Bekanntheitsgrad sowie die Anerkennung des bisher geleisteten vom breiten Markt anerkannt würde. We will see, bin immer noch long und die Aussichten sind immer noch nach der Roadmap intakt.
wenn man sich das volumen anschaut, müssen auch noch andere letzte Zeit in arqule rein gegangen sein.
performance der letzten drei monate ist beachtlich.
gruss
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