NASHVILLE, Tenn., Jan. 30, 2018 /PRNewswire/ -- Cumberland
Pharmaceuticals Inc. (NASDAQ: CPIX), a U.S. specialty
pharmaceutical company and Clinigen Group plc (AIM: CLIN,
'Clinigen'), the global pharmaceutical and services company,
announce a new publication in Leukemia & Lymphoma, with
study results showing that amifostine decreases gastro-intestinal
(GI) toxicity in patients who receive treatment for their multiple
myeloma. Cumberland markets
branded amifostine in the U.S. under the name
Ethyol®.
Multiple myeloma remains incurable, despite the significant
improvement in treatment over the past 10 years. Data predicts that
there will be over a 57% increase in the number of multiple myeloma
patients by 2030 as a result of achieving longer survival for these
patients and the population aging. Gastrointestinal (GI) toxicities
such as nausea, vomiting, diarrhea and ulcers in mouth are a major
limitation to the use of autologous hematopoietic cell
transplantation (auto-HTC), especially in the elderly population
which constitutes a significant proportion of multiple myeloma
patients. Preventing GI toxicities for these patients without
compromising efficacy of transplant is an important goal that could
lead to an expansion of transplant eligibility criteria to older
patients.
The study, led by Ehsan Malek, MD
at Case Western Reserve University,
assessed multiple myeloma patients receiving high dose melphalan
followed by auto-HTC. It consisted of patients at University
Hospitals Seidman Cancer Center in Cleveland, OH and the MD Anderson Cancer
Center in Houston, TX. It
evaluated the impact of amifostine on reducing GI toxicities among
multiple myeloma patients undergoing transplant.
Amifostine is used to reduce the side effects of certain
chemotherapy agents and radiation treatment. It is known as a
cytoprotective agent, protecting the body from some of the
potentially serious side effects of treatment. One hundred and
seven patients participated in this study. Amifostine 740 mg was
administered at 24 hours and 15 min before high-dose melphalan. The
study concluded that amifostine therapy decreased GI toxicity
without any significant adverse effects while preserving the
anti-myeloma efficacy of high-dose melphalan and auto-HTC.
About Ethyol® (amifostine)
Ethyol is indicated to reduce the cumulative renal toxicity
associated with repeated administration of cisplatin in patients
with advanced ovarian cancer. It is indicated to reduce the
incidence of moderate to severe xerostomia in patients undergoing
post-operative radiation treatment for head and neck cancer, where
the radiation port includes a substantial portion of the parotid
glands. Xerostomia, or diminished saliva production, can lead to
difficulties eating, speaking, and swallowing.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty
pharmaceutical company focused on the delivery of high-quality
prescription brands to improve patient care. The Company develops,
acquires, and commercializes brands for the hospital acute care,
gastroenterology, and oncology market segments.
The Company's portfolio of FDA approved brands includes:
- Acetadote® (acetylcysteine) Injection,
for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) Injection, for
the treatment of pain and fever;
- Kristalose® (lactulose) for Oral
Solution, a prescription laxative, for the treatment of chronic and
acute constipation;
- Omeclamox®-Pak, (omeprazole,
clarithromycin, amoxicillin) for the treatment of Helicobacter
pylori (H. pylori) infection and related duodenal ulcer
disease;
- Vaprisol® (conivaptan) Injection, to
raise serum sodium levels in hospitalized patients with euvolemic
and hypervolemic hyponatremia;
- Ethyol® (amifostine) Injection, for
the reduction of xerostomia (dry mouth) in patients undergoing
post-operative radiation treatment for head and neck cancer and the
renal toxicity associated with the administration of cisplatin in
patients with advanced ovarian cancer;
- Totect® (dexrazoxane hydrochloride)
Injection, for emergency oncology intervention, to treat the toxic
effects of anthracycline chemotherapy in case of extravasation
(drug leakage from the bloodstream into the tissues).
Cumberland's pipeline of
product candidates includes:
- Hepatoren® (ifetroban) Injection, a
Phase II candidate for the treatment of critically ill patients
suffering from liver and kidney failure associated with hepatorenal
syndrome ("HRS");
- Boxaban® (ifetroban) Oral Capsules, a
Phase II candidate for the treatment of asthma patients with
aspirin-exacerbated respiratory disease ("AERD");
- Vasculan® (ifetroban) Oral Capsules, a
Phase II candidate for the treatment of patients with systemic
sclerosis (SSc) form of autoimmune disease;
- Portaban (ifetroban) Injection
and Oral Capsules, a Phase II candidate for the treatment of
patients with portal hypertension associated with liver
disease;
- Reditrex™ (methotrexate) Injection, an
approval submission candidate for the treatment of active
rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as
well as severe disabling psoriasis.
For more information on Cumberland's approved products, including full
prescribing information, please visit the individual product
websites, links to which can be found on the Company's website
www.cumberlandpharma.com.
About Clinigen Group
Clinigen Group plc (AIM: CLIN)
is a global pharmaceutical and services company with a unique
combination of businesses focused on providing access to medicines.
Its mission is to deliver the right medicine to the right patient
at the right time through three areas of global medicine supply;
clinical trial, unlicensed and licensed medicines.
For more information, please visit www.clinigengroup.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/newly-published-data-demonstrates-amifostine-reduces-gastro-intestinal-toxicity-for-multiple-myeloma-patients-300590255.html
SOURCE Cumberland Pharmaceuticals Inc.