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
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 2,500+ scientific posters on ePosters
  • More Than 3,700+ 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
Liquid Biopsies: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Self-Assembling, Biomimetic Membranes May Aid Water Filtration
A synthetic membrane that self assembles and is easily produced may lead to better gas separation, water purification, drug delivery and DNA recognition, according to an international team of researchers.
Researchers Discover Immune System’s 'Trojan Horse'
Oxford University researchers have found that human cells use viruses as Trojan horses, transporting a messenger that encourages the immune system to fight the very virus that carries it.
Study Finds Brain Chemicals that Keep Wakefulness in Check
Researchers to develop new drugs that promote better sleep, or control hyperactivity in people with mania.
Sorting Through Cellular Statistics
Aaron Dinner, professor in chemistry, and his graduate student Herman Gudjonson are trying to read the manual of life, DNA, as part of the Dinner group’s research into bioinformatics—the application of statistics to biological research.
Playing 'Tag' with Pollution lets Scientists See Who's It
Using a climate model that can tag sources of soot from different global regions and can track where it lands on the Tibetan Plateau, researchers have determined which areas around the plateau contribute the most soot — and where.
Women’s Immune System Genes Operate Differently from Men’s
A new technology reveals that immune system genes switch on and off differently in women and men, and the source of that variation is not primarily in the DNA.
Long Telomeres Associated with Increased Lung Cancer Risk
Genetic predisposition for long telomeres predicts increased lung adenocarcinoma risk.
First Artificial Ribosome Designed
Researchers at the University of Illinois at Chicago and Northwestern University have engineered a tethered ribosome that works nearly as well as the authentic cellular component, or organelle, that produces all the proteins and enzymes within the cell.
High-Resolution 3D Images Reveal the Muscle Mitochondrial Power Grid
NIH mouse study overturns scientific ideas on energy distribution in muscle.
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!