Moleculin Biotech (MBRX)

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Munnybunny
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Re: Moleculin Biotech (MBRX)

Bericht door Munnybunny »

Volgende week volgt mss de IND goedkeuring. Volgens laatste CC midden april sprak men van 6-8 weken.

Ik verwacht daarom een stijging in aanloop naar of op een PB.





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Munnybunny
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Re: Moleculin Biotech (MBRX)

Bericht door Munnybunny »

$1.18 PM
letta75 liked last!

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Re: Moleculin Biotech (MBRX)

Bericht door Munnybunny »

Bevestiging van de resultaten door de FDA, helaas IND uitstel tot eind 2020.

BRIEF-Moleculin Announces Confirmatory In Vitro Analysis Of WP1122


* MOLECULIN ANNOUNCES CONFIRMATORY IN VITRO ANALYSIS OF WP1122

* MOLECULIN BIOTECH INC - ANNOUNCED THAT A REPEAT OF PREVIOUS IN VITRO TESTING HAS CORROBORATED ANTIVIRAL POTENTIAL OF WP1122


* MOLECULIN BIOTECH - RESULTS OF REPEATED ROUND OF IN VITRO TESTING RECEIVED, CONFIRM WP1122 HAS AN ANTIVIRAL EFFECT ON HUMAN CORONAVIRUS 229E

* MOLECULIN BIOTECH - EXPECTS TO FILE REQUEST FOR IND STATUS TO TEST WP1122 FOR TREATMENT OF COVID-19 PATIENTS DURING H2 2020

Munnybunny
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Re: Moleculin Biotech (MBRX)

Bericht door Munnybunny »

Bevestiging van de resultaten door de FDA, helaas IND uitstel tot eind 2020.

BRIEF-Moleculin Announces Confirmatory In Vitro Analysis Of WP1122


* MOLECULIN ANNOUNCES CONFIRMATORY IN VITRO ANALYSIS OF WP1122

* MOLECULIN BIOTECH INC - ANNOUNCED THAT A REPEAT OF PREVIOUS IN VITRO TESTING HAS CORROBORATED ANTIVIRAL POTENTIAL OF WP1122


* MOLECULIN BIOTECH - RESULTS OF REPEATED ROUND OF IN VITRO TESTING RECEIVED, CONFIRM WP1122 HAS AN ANTIVIRAL EFFECT ON HUMAN CORONAVIRUS 229E

* MOLECULIN BIOTECH - EXPECTS TO FILE REQUEST FOR IND STATUS TO TEST WP1122 FOR TREATMENT OF COVID-19 PATIENTS DURING H2 2020

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Re: Moleculin Biotech (MBRX)

Bericht door Munnybunny »

Based on the FDA's response, Moleculin now plans to present its non-GLP toxicology, when available, to the FDA in a second Pre-IND meeting request. While there can be no assurance that the FDA will allow Moleculin's IND to go into effect on the basis of non-GLP toxicology data, the Company believes the possibility is worth pursuing, because it could significantly reduce its timeline to begin clinical trials for WP1122.

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Re: Moleculin Biotech (MBRX)

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New Publication Finds Combination of WP1066 and Radiation Resulted in Long-Term Survival in Human Brain Tumor Mouse Model

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

NEWS PROVIDED BY
Moleculin Biotech, Inc.
Jul 01, 2020, 07:30 ET

HOUSTON, July 1, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that a peer-reviewed article published in Clinical Cancer Research (Clin Cancer Res June 30 2020 DOI:10.1158/1078-0432.CCR-19-4092) reported findings that Moleculin's STAT3 inhibitor, WP1066, used in combination with traditional whole brain radiation therapy (WBRT) resulted in long-term survivors and enhanced median survival time relative to monotherapy in mice with implanted human brain tumors.

The paper can be accessed at: https://clincancerres.aacrjournals.org/ ... l-text.pdf

The study was performed by lead author Martina Ott, Ph.D., Instructor of Neurosurgery, senior author Amy Heimberger, M.D., professor of Neurosurgery, and a team of researchers at The University of Texas MD Anderson Cancer Center. Heimberger also is the Principle Investigator of the current investigator-initiated clinical trial of WP1066 for brain tumors.

In the current study, C57BL/6 mice underwent intracerebral implantation of GL261 glioma cells, WBRT, and treatment with WP1066, a blood-brain barrier penetrant inhibitor of the STAT3 pathway, or the two in combination. The role of the immune system was evaluated using tumor rechallenge strategies, immune incompetent backgrounds, immunofluorescence, immune phenotyping of tumor-infiltrating immune cells (via flow cytometry), and nanostring gene expression analysis of 770 immune-related genes from immune cells, including those directly isolated from the tumor microenvironment.

The combination of WP1066 and WBRT resulted in long-term survivors and enhanced median survival time relative to monotherapy in the GL261 glioma model (combination vs. control p<0.0001). Immunological memory appeared to be induced, because mice were protected during subsequent tumor rechallenge. The therapeutic effect of the combination was completely lost in immune incompetent animals. Nanostring analysis and immunofluorescence revealed immunological reprogramming in the brain tumor microenvironment specifically affecting dendritic-cell antigen presentation and T cell effector functions. The study indicates that the combination of STAT3 inhibition and WBRT enhances the therapeutic effect against gliomas in the CNS by inducing dendritic-cell and T cell interactions in the brain tumor, which seems to be a requirement for a fully functional immune response

"This impressive study confirms preliminary data we announced last year," commented Walter Klemp, Chairman and CEO of Moleculin. "Importantly, the study indicated that the combination of STAT3 inhibition with whole brain radiotherapy had the capacity to enhance the therapeutic effect against established tumors as well as developing immune memory that appears to prevent recurrence."



https://www.prnewswire.com/news-release ... 86563.html

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Re: Moleculin Biotech (MBRX)

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Nog een PR

Moleculin Provides Update on Annamycin Clinical Development

Jul 02, 2020, 07:30 ET

HOUSTON , July 2, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX ) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced an update on its clinical development plan for Annamycin.

After consultation with both US and European regulatory agencies, Moleculin has mapped out a course for development of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML"). In its End of Phase 1 meeting with the US Food and Drug Administration ("FDA") the Company agreed to expand its protocol-mandated testing for cardiotoxicity throughout the remainder of its European Phase 1 trial. The expansion of testing will provide additional safety data, investigating the continued evidence of little to no cardiotoxicity, and efficacy data that both US and European regulators may consider as the Company prepares to transition to a Phase 2 clinical trial, which management believes will focus on Europe .

Moleculin has now received approval from European authorities to increase the increment for dose-escalation from 30 mg/m 2 per cohort to 60 mg/m 2 per cohort, as treatment to date in its clinical trials has been at what the Company considers to be subtherapeutic levels. The first patient in the European trial has now been treated at 240 mg/m 2 with no evidence of cardiotoxicity or other dose limiting toxicities. Once 2 more patients are successfully treated at this level, the next cohort will be treated with 300 mg/m 2 . With these timing and dosing expectations, the Company believes that European dosing will increase in 2020, allowing a recommended Phase 2 Dose to be established in 2021.

"Based on what we know from prior clinical trials, we think it may require a dose level of 300 to 360 mg/m 2 , or possibly higher, before we begin to see a solid therapeutic window for Annamycin in AML," commented Walter Klemp , Chairman and CEO of Moleculin. "Now, with 5 clinical sites open in Poland , the European trial is in the best position to complete the safety portion of our development. That also allows us to close out the US trial, which has already reached its primary safety endpoint."

The Company intends to use what it learns from the Phase 1 clinical trials in AML to inform the starting dosage in clinical testing of Annamycin for the treatment of lung metastases, for which it hopes to file an Investigational New Drug application or its European equivalent by the end of this year.

Mr. Klemp concluded: "With the confirmation of animal model activity in lung metastases we just announced last week, we are pushing hard to prepare to seek regulatory approval to begin a Phase 1 clinical trial in sarcomas that have metastasized to the lungs, a condition for which there is a significant unmet need."

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