FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug To Prevent Chemotherapy Induced Hearing Loss

Main Category: Hearing / Deafness
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 09 Aug 2008 - 0:00 PDT

Current ratings for:
'FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug To Prevent Chemotherapy Induced Hearing Loss'

Patient / Public:4 and a half stars

4.5 (4 votes)

Healthcare Prof:4 stars

4 (1 votes)


Sound Pharmaceuticals (SPI) has received FDA notification that it may proceed with its Phase II study to prevent chemotherapy induced hearing loss. The Ph-II study will enroll 80 patients with advanced head and neck, and non-small cell lung cancer at the National Center for Rehabilitative Auditory Research at the Veterans Administration Hospital and the Oregon Health and Science University in Portland, Oregon.

Hearing loss due to ototoxic medications such as chemotherapy, antibiotics or loop diuretics often results in permanent and progressive disability. Furthermore, the combined use of these ototoxic agents is contraindicated, often limiting their clinical utility. Symptoms of ototoxicity include hearing loss, tinnitus, dizziness, vertigo and difficulty understanding speech. Historically, the incidence of cisplatin or carboplatin-induced hearing loss was widely under estimated or reported due to inadequate testing or a lack of reporting. Recently, a new behavioral audiometric protocol has been developed and employed to test an individual's sensitive range for ototoxicity (SRO). This involves pure-tone audiometry at very specific steps within a person's upper range of hearing. With the SRO protocol, several studies now report an incidence of ototoxicity of 85-92% for cisplatin and carboplatin receiving cancer patients, an incidence that is much greater than previously reported. One of the goals of this Ph-II study is to reduce the incidence and severity of the ototoxicity in platinum receiving cancer patients as measured by pure-tone audiometry using the SRO protocol, distortion product otoacoustic emissions (DPOAEs) and the tinnitus handicap inventory. DPOAEs are a measure of outer hair cell function in the inner ear and are another sensitive and specific measure of ototoxicity.

In several preclinical studies, SPI has showed that its novel chemoprotectant drug product, a small molecule that mimics and induces Glutathione Peroxidase activity was critical in preventing ototoxicity while not interfering with the chemotherapy treatment. In one rodent model of cancer, the chemoprotectant enhanced the tumoricidal activity of cisplatin.

Sound Pharmaceuticals, Inc.
http://www.soundpharma.com

Article adapted by Medical News Today from original press release.
Visit our hearing / deafness section for the latest news on this subject.
There are no references listed for this article.
Please use one of the following formats to cite this article in your essay, paper or report:

MLA
Sound Pharmaceuticals, Inc. "FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug To Prevent Chemotherapy Induced Hearing Loss." Medical News Today. MediLexicon, Intl., 9 Aug. 2008. Web.
23 May. 2012. <http://www.medicalnewstoday.com/releases/117759.php>

APA
Sound Pharmaceuticals, Inc. (2008, August 9). "FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug To Prevent Chemotherapy Induced Hearing Loss." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/117759.php.

Please note: If no author information is provided, the source is cited instead.



Add Your Opinion On This Article

'FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug To Prevent Chemotherapy Induced Hearing Loss'

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Your Name:*
E-mail Address:*
Your Opinion Title:*
Opinion:*
This is to help prevent SPAM submissions. Please enter the words exactly as they appear, including capital letters and punctuation.*

* Fields marked with a * need to be filled in before you hit the submit button.

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.


Hearing / Deafness

Most Popular Articles



Follow Our Hearing News On Twitter

Follow Us On Twitter
Get the latest news for this category delivered straight to your Twitter account. Simply visit our Hearing / Deafness Twitter account and select the 'follow' option.



View list of all 'What Is...' articles »