Corporate Banner
Satellite Banner
RNAi
Scientific Community
 
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 3,000+ scientific posters on ePosters
  • More than 4,400+ 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.


Scientific News
Detection of HPV in First-Void Urine
Similar sensitivity of HPV test on first void urine sample compared to cervical smear.
Potential “Good Fat” Biomarker
New method to measure the activity of energy consuming brown fat cells could ease the testing weight loss drugs.
Shape Of Tumor May Affect Whether Cells Can Metastasize
Illinois researchers found that the shape of a tumor may play a role in how cancer cells become primed to spread.
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Analysis of Dog Genome will Provide Insight into Human Disease
An important model in studying human disease, the non-coding RNA of the canine genome is an essential starting point for evolutionary and biomedical studies – according to a new study led by The Genome Analysis Centre (TGAC).
New Blood Test for The Earlier Diagnosis of Breast Cancer Spread
Researchers at University of Westminster have confirmed that a new blood test can detect if breast cancer has spread to other parts of the body.
First Gene Therapy Successful Against Human Aging
American woman gets biologically younger after gene therapies.
Targeting an ‘Undruggable’ Cancer Gene
RAS genes are mutated in more than 30 percent of human cancers and represent one of the most sought-after cancer targets for drug developers.
Altered Metabolism of Four Compounds Drives Glioblastoma Growth
Findings suggest new ways to treat the malignancy, slow its progression and reveal its extent more precisely.
Improving Engineered T-Cell Cancer Treatment
Purdue University researchers may have figured out a way to call off a cancer cell assassin that sometimes goes rogue and assign it a larger tumor-specific "hit list."
SELECTBIO

SELECTBIO Market Reports
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!