Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Acacia Pharma Announces Positive Results from Phase IIa Study

Published: Tuesday, October 09, 2012
Last Updated: Tuesday, October 09, 2012
Bookmark and Share
Phase IIa proof-of-concept study investigate APD403 for the prevention of acute nausea & vomiting in cancer patients.

Acacia Pharma has announced positive results from its Phase IIa proof-of-concept study investigating APD403 for the prevention of acute nausea & vomiting in cancer patients receiving the highly emetogenic chemotherapy drug cisplatin.

Although a number of anti-emetics are available on the market, these are generally much better at controlling vomiting than nausea.

Therefore, nausea remains the major unmet medical need for cancer patients receiving cisplatin, and many other kinds of chemotherapy.

The study, exploring the efficacy of APD403 alone and in combination with ondansetron, a 5-HT3-antagonist approved for prevention and treatment of CINV, took place in four hospitals in Denmark and the UK.

Fifty-one patients were enrolled into four cohorts, three treated with different doses of single-agent APD403 and the fourth treated with the combination of APD403 and a standard dose of intravenous ondansetron.

The primary endpoint was complete response, defined as no vomiting and no requirement for anti-emetic rescue medication during the first 24 hours after dosing with cisplatin. Secondary endpoints included incidence and severity of nausea as well as safety.

In the initial exploratory cohorts, single agent APD403 showed encouraging benefit, especially in controlling nausea. When APD403 was combined with a standard dose of intravenous ondansetron, a complete response in 19 out of 23 patients (83%) was achieved, substantially higher than the 50% rate which would be expected with ondansetron alone.

Most promisingly, the response rate of this two drug combination is comparable to the standard of care regimen of three anti-emetics currently recommended by international experts therefore offering potential safety and compliance advantages.

Nausea was rarely reported (measured on a 100 mm visual analogue scale (VAS), where 0 is no nausea and 100 is the worst nausea possible).

Only 2 of the 23 patients receiving the combination spontaneously reported significant nausea requiring rescue anti-emetic medication.

Nausea scores were also collected prospectively 4 times during the 24-hour observation period and only 2 out of 91 VAS measurements were above 5 mm. No clinically significant side effects were seen in the study.

Dr Julian Gilbert, Acacia Pharma’s CEO said, “APD403 appears to be a safe and powerful anti-sickness drug, capable of virtually wiping out nausea in cancer patients receiving cisplatin. This is extremely encouraging as controlling nausea is now the main priority in the management of CINV.”

Acacia Pharma’s CMO, Dr Gabriel Fox, added, “The efficacy seen with APD403 in combination with ondansetron is exceptional and appears to match the triple combination of ondansetron, aprepitant and dexamethasone recommended for preventing CINV induced by cisplatin. This could give physicians a chance to simplify the management of these patients and significantly reduce unwanted side effects.”

APD403 comprises a completely new, patent protected use of a currently marketed dopamine D2/D3 antagonist for the prevention and treatment of chemotherapy induced nausea & vomiting (CINV).

The same active ingredient is also being developed by Acacia Pharma as APD421 for the prevention of post-operative nausea & vomiting (PONV).


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More Than 4,600+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Acacia Initiates Phase IIA Study with APD209 in Cancer Cachexia Patients
Acacia Pharma announced the initiation of a Phase IIa study of its product APD209 to treat cachexia in cancer patients.
Tuesday, March 31, 2009
Scientific News
Platelets are the Pathfinders for Leukocyte Extravasation During Inflammation
Findings from the study could help in the prevention and treatment of inflammatory pathologies.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
How Cancer Spreads in the Body
Cancer cells appear to depend on an unusual survival mechanism to spread around the body, according to an early study led by Queen Mary University of London.
Fix for 3-Billion-Year-Old Genetic Error
Researchers at The University of Texas at Austin have developed a fix that allows RNA to accurately proofread for the first time.
“Amazing Protein Diversity” Discovered in Maize
The genome of the corn plant – or maize, as it’s called almost everywhere except the US – “is a lot more exciting” than scientists have previously believed. So says the lead scientist in a new effort to analyze and annotate the depth of the plant’s genetic resources.
Manufactured Stem Cells to Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Dengue Virus Exposure May Amplify Zika Infection
Researchers at Imperial College London have found that the previous exposure to the dengue virus may increase the potency of Zika infection.
Gender Determination in Forensic Investigations
This study investigated the effectiveness of lip print analysis as a tool in gender determination.
Identifying Novel Types of Forensic Markers in Degraded DNA
Scientists have tried to verify the nucleosome protection hypothesis by discovering STRs within nucleosome core regions, using whole genome sequencing.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!