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Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6

Retrieved on:

Thursday, April 18, 2024

The completed comments form should be sent to

Key Points:

The completed comments form should be sent to
[email protected]
10
11
Keywords
Committee on Herbal Medicinal Products; HMPC; European Union herbal
monographs; European Union list of herbal substances, preparations and
combinations thereof for use in traditional herbal medicinal products; herbal
medicinal products; traditional herbal medicinal products; traditional use;
well-established medicinal use; benefit-risk assessment; assessment report

12

1
2

Changes introduced in section 6 Overall conclusions.
Peer-reviewer

If not the same peer-reviewer
since last version, all peerreviewers should be listed, and
the version specified in
brackets.
22

23

on
.
It is a working
24

document, not yet edited, and shall be further developed after the release for consultation of the

25

.
The principle of the template is to make clear
distinctions between presentation of data (methodology and results)
and the assessment of the data (?assessor?s comment?).
likely from an article but it seems it is concluded by
the rapporteur; ?According to the author? to be added.
Chapters with
a heading including the word ?conclusion? should include a summary
of all critical assessment of the assessor for that particular
chapter.
If an assessor?s comment is not needed, the Rapporteur
should delete the box inserted in the template.
?
The report should be sufficiently detailed to allow for secondary
assessment of the available data by other HMPC experts.
Overview of available pharmacokinetic data regarding the herbal substance(s), herbal
preparation(s) and relevant constituents thereof ........................................................... 16
97
98

3.3.
Overall conclusions on clinical pharmacology and efficacy ........................................ 27
Assessment report on
EMA/HMPC/418902/2005

Page 4/41

119

5.
This sections is related to
available quality standards and there is no need to repeat information
on all preparations included in the monograph.
Search and assessment methodology
161

The Rapporteur shall undertake a comprehensive search of relevant
scientific literature and articles, Acts of law and regulations and
other relevant sources.
Cross-reference to the list of
references in Annex, which should list separately the references
supporting the assessment report.
143
144
145
150
151
152
153
154

162
163
164
165
166
167
168
169
170
171
172
173
174
175

Herbal substance(s)

Herbal preparation(s)

Relevant constituents for this assessment report

Examples of scientific databases to be searched are Medline, PubMed,
Cochrane Database of Systematic Reviews, EMBASE etc.
Assessment report on
EMA/HMPC/418902/2005
Page 6/41

176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192

Additional relevant references could also be retrieved from the checked
references.
Examples of books are Hagers Handbuch, The Complete German
Commission E Monographs, PDR for herbal medicines etc.
In addition, information from non-EU regulatory
authorities for examples Health Canada monographs or WHO monographs
could be searched, if relevant to herbal substances and preparations in
EU.
221
225
226
227

232

When the assessment report is revised, the rapporteur should briefly
summarise the main changes under this section.
Data are collected using the template entitled ?Document
for information exchange for the preparation of the assessment report
for the development of European Union monographs and for inclusion of
herbal substance(s), preparation(s) or combinations thereof in the
list? (EMEA/HMPC/137093/2006).
Assessment report on
EMA/HMPC/418902/2005
Page 8/41

Herbal substance/

Indication

Posology and
method of

preparation

administration

Posology, age
groups,
pharmaceutical
form, method of
administration,
duration of use
As reported in
the market
overview

As reported in
the market
overview

As reported in
the market
overview.
Assessment report on
EMA/HMPC/418902/2005
Page 10/41

Herbal substance/

Indication/Medicinal

Posology and

preparation

use

method of
administration

Posology, age
groups,
pharmaceutical
form, method of
administration,
duration of use

Regulatory Status

Type of
regulatory
status where
possible, date,
Country

287

This overview is not exhaustive.
Clinical Safety/Pharmacovigilance
836
837
838
839
840
841

See ?Assessment of clinical safety and efficacy in the preparation of
EU herbal monographs for well-established and traditional herbal
medicinal products?(EMA/HMPC/104613/2005) for further details.
Overall conclusions on clinical safety
1067

1068

In terms of structure, the conclusion should follow the presentation of
the results above.
Overall conclusions
1092

1093

1101

Describe key aspects only briefly, these will already have been
described in detail in the respective sections.
This section should
cover all recommended ?well-established use? and ?traditional use?
indications and conclusions shall be provided for each therapeutic
indication and each herbal preparation.
1102
Well established use monograph

1103
1104

The clinical studies supporting well-established use should be
specified for each therapeutic indication and each herbal preparation.
The choice for the wording of traditional use indications vis-?vis existing wordings in monographs in the same therapeutic area should
be briefly discussed/justified.
1153
List entry

1154

The conclusions should include a statement pointing to the
possibility/non-possibility to support a European Union list entry.

Acrivon Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on:

Thursday, March 28, 2024

“On the heels of a productive 2023, we are off to a tremendous start in 2024, which is an important and data-driven year for Acrivon,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon.

Key Points:

“On the heels of a productive 2023, we are off to a tremendous start in 2024, which is an important and data-driven year for Acrivon,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon.
We remain on track to present more mature clinical data during the first half of 2024.
Additionally, our novel WEE1/PKMYT1 inhibitor ACR-2316 continues to demonstrate robust and superior single-agent preclinical activity and tolerability as demonstrated in head-to-head benchmark studies.
As of December 31, 2023, the company had cash, cash equivalents and marketable securities of $127.5 million, which is expected to fund operations into the fourth quarter of 2025.

Vidac Pharma receives Japanese Patent Office Notice of Allowance for VDA-1275 cancer drug candidate

Retrieved on:

Wednesday, March 27, 2024

Cell proliferation, Apoptosis, Survival, Patent, Colorectal cancer, T-cell lymphoma, Neoplasm, Guard cell, Mitochondrion, IC50, Cisplatin, HK2, Sorafenib

(Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments, today announces it has received a Notice of Allowance from the Japanese Patent Office for the composition and methods of use for its VDA-1275 drug candidate, which has shown multiple promising effects in preclinical studies.

Key Points:

(Hamburg and Stuttgart: T9G; ISIN:GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments, today announces it has received a Notice of Allowance from the Japanese Patent Office for the composition and methods of use for its VDA-1275 drug candidate, which has shown multiple promising effects in preclinical studies.
“Receiving this notice from the Japanese authorities adds to our excitement about VDA-1275, Vidac’s next and powerful anti-cancer drug candidate.
Cancer cells overexpress HK2, which catalyzes the first step of the glucose metabolism necessary to fuel tumor growth.
Clinical data for Vidac’s first-generation metabolic checkpoint modulator candidates have shown powerful effects in halting cancer cell proliferation and restoring immune-sensitivity and apoptosis.

Ventyx Biosciences Reports Clinical Data for its NLRP3 Inhibitor Portfolio and Provides Pipeline Updates at Virtual Investor Event

Retrieved on:

Monday, March 11, 2024

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, will provide clinical and pipeline updates today during its virtual investor event.

Key Points:

We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases.
We believe these data establish compelling clinical proof of concept for our peripheral NLRP3 inhibitor VTX2735.
At our virtual investor event, we will present data from the ongoing Phase 2 open-label extension.
Ventyx will host a virtual investor event today, Monday, March 11, 2024 from 11:00AM to 12:30PM ET.

Anti-Cancer Drugs Publishes Preclinical Data Demonstrating the Broad Antineoplastic Activity of Panavance’s Misetionamide (GP-2250)

Retrieved on:

Thursday, February 1, 2024

Gemcitabine, Research, Patient, Apoptosis, PARP, Bevacizumab, EC50, Quality of life, Cancer, IC50, Doctor of Philosophy, Pharmaceutical industry

BERWYN, PA, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Panavance Therapeutics Inc. (“Panavance” or the “Company”), a clinical-stage pharmaceutical company advancing the development of a novel oncology therapeutic intended to improve the outcomes and quality of life for patients, today announced publication of positive data in the peer-reviewed Anti-Cancer Drugs in an article titled, “Antineoplastic Activity of GP-2250 In Vitro and in Mouse Xenograft Models.”1 The publication by Sofia et al. (2024) provided early research evidence that misetionamide exhibits a dose-dependent antineoplastic effect on both established cancer cell lines and xenograft models from patient tissues.2 Antineoplastic activity was tested in over 300 cancer cell lines using the OncoPanel® cytotoxicity assay and was further tested in eight human cancer xenograft models.

Key Points:

Most notably in the ovarian tumor xenograft model, misetionamide produced a regression in the original tumor volume.
Concentrations for IC50 and EC50 were determined as was the concentration at which a 10-fold increase in apoptosis was induced.
In addition, misetionamide was also shown to induce a cancer cell cycle block that would inhibit tumor cells from replicating and thus inhibiting tumor growth.
“The results from these studies demonstrate that misetionamide has a broad mechanism of action which could be impactful in treating most cancers.

ExeVir Bio Announces Positive Virus Neutralization Data for XVR012 Against Emerging COVID-19 Omicron Variants

Retrieved on:

Monday, January 15, 2024

Patient, Epitope, Omicron, Risk, Public, Infection, Immunodeficiency, IC50, WHO, COVID-19, Antibody, Virus, Vaccine, SARS-CoV-2

All authorized SARS-CoV-2 therapeutic antibodies that have been used in the clinic show severe to complete loss of virus neutralization potency against the currently circulating variants.

Key Points:

All authorized SARS-CoV-2 therapeutic antibodies that have been used in the clinic show severe to complete loss of virus neutralization potency against the currently circulating variants.
ExeVir’s XVR012, a cocktail of XVR013m and XVR014, targets three distinct epitopes highly conserved across the broad sarbecovirus subgenus of Coronaviridae to minimize the risk for viral escape.
XVR013m is a heavy chain-only antibody targeting a unique membrane-proximal epitope in the S2 subunit of the spike protein.
ExeVir is currently gearing up to start the clinical development of both the combination XVR012, as well as its individual components XVR013m and XVR014.

Aclaris Therapeutics Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis

Retrieved on:

Wednesday, January 10, 2024

ACRS, Patient, Therapy, Infection, Common, Malignancy, U.S. FDA, JAK, MACE, Aes, IC50, Plasma, Safety, Atopic dermatitis, BID, Clinical trial, Pharmacokinetics, QD, Pharmaceutical industry

WAYNE, Pa., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced top-line results from its Phase 2b study of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (AD) (ATI-1777-AD-202; NCT05432596). ATI-1777 was generated from Aclaris’ proprietary KINect® drug discovery platform.

Key Points:

For this trial, ATI-1777 was developed as an emollient-containing spray formulation.
The trial randomized 250 patients with mild, moderate or severe AD, including adults and children as young as 12 years old, across 30 clinical trial sites in the United States.
“The trial demonstrated efficacy results, a pharmacokinetic profile and safety results that were consistent with what was seen in the Phase 2a trial of ATI-1777,” stated Dr. Neal Walker, Aclaris’ Chairman of the Board of Directors.
These results are particularly encouraging given the higher than anticipated vehicle response and the mid-study inclusion of a milder patient population.

Invivyd Announces Positive Initial Results from Ongoing CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of COVID-19

Retrieved on:

Monday, December 18, 2023

Immunodeficiency, IC50, FDA, Half-life, Clinical trial, IC, COVID-19, Science Translational Medicine, SARS-CoV-2, Safety, Vaccine

“VYD222 produced high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the IC cohort, essentially replicating the titer levels observed in our Phase 1 clinical trial of VYD222 in healthy volunteers.

Key Points:

“VYD222 produced high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the IC cohort, essentially replicating the titer levels observed in our Phase 1 clinical trial of VYD222 in healthy volunteers.
We are also encouraged by the potential early signal of strong clinical protection from symptomatic COVID-19 in the CANOPY clinical trial to date, which would be expected given the high VYD222 sVNA titer levels and dose selected.
We are encouraged by the initial results from CANOPY that we believe are supportive of an immunobridging approach for VYD222.
Importantly, VYD222 continues to show neutralizing activity against variants with the F456L mutation that is found in the majority of variants in the U.S. currently.

Ryvu Therapeutics Presents Preclinical Data on PRMT5 and its Synthetic Lethality Platform at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Retrieved on:

Monday, October 16, 2023

"We are pleased with preclinical data underscoring the promise of our synthetic lethality platform, as highlighted by our leading preclinical program on PRMT5 inhibitors," said Krzysztof Brzózka, Ph.D., Chief Scientific Officer of Ryvu Therapeutics.

Key Points:

"We are pleased with preclinical data underscoring the promise of our synthetic lethality platform, as highlighted by our leading preclinical program on PRMT5 inhibitors," said Krzysztof Brzózka, Ph.D., Chief Scientific Officer of Ryvu Therapeutics.
Our potentially best-in-class MTA-cooperative PRMT5 inhibitors exhibit significantly improved pharmacokinetics relative to other PRMT5 inhibitors currently in development.
Given their in vivo target engagement and remarkable anti-tumor efficacy, we anticipate further development and progression to IND-enabling studies in 2024.
Webinar on PRMT5 and synthetic lethality pipeline, including WRN project and target discovery efforts
Ryvu will host a webinar today at 9:30 am CEST to discuss the PRMT5 data.

Nuvectis Pharma Announces Initiation of the NXP900 Phase 1a Clinical Trial

Retrieved on:

Tuesday, September 12, 2023

SRC, Survival, SFK, Clinical trial, Entrepreneurship, Patient, IC50, Cell adhesion, Safety, YES1, Pharmaceutical industry

Fort Lee, NJ, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the initiation of a Phase 1a dose escalation clinical trial of NXP900, its novel inhibitor of the SRC/YES1 kinase family (“SFK”).

Key Points:

Fort Lee, NJ, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the initiation of a Phase 1a dose escalation clinical trial of NXP900, its novel inhibitor of the SRC/YES1 kinase family (“SFK”).
The study is designed to evaluate the safety, tolerability and pharmacokinetic properties of NXP900 in patients with advanced solid tumors.
SFKs are aberrantly activated in various cancer types and they are central mediators of various oncogenic processes such as proliferation, survival, cell adhesion, invasion, and angiogenesis.
NXP900 is a potent and highly selective SFK inhibitor, including low nanomolar IC50 against YES1 and SRC (0.5nM and 2.4nM, respectively) that demonstrated robust single agent anti-cancer activity against several solid tumor types in preclinical models.