Rising Pharmaceuticals & Laurus Labs to Support a Phase 2 Randomized Clinical Trial of Hydroxychloroquine for Prophylaxis Against COVID-19 in Patients Receiving Cancer Therapy

Trial conducted at Memorial Sloan Kettering Cancer Center designed to evaluate potential risk reduction for patients at risk for coronavirus infection

EAST BRUNSWICK N.J.--(BUSINESS WIRE)--Rising Pharma Holdings, Inc., operating as Rising Pharmaceuticals, today announced the donation of Hydroxychloroquine tablets in support of a Phase 2 randomized clinical trial exploring hydroxychloroquine as preventive treatment for coronavirus disease 2019 (COVID-19) in patients with cancer who are receiving radiation therapy.

The trial is being conducted at Memorial Sloan Kettering Cancer Center (MSK), a global leader in cancer care. The randomized, placebo-controlled Phase 2 trial will enroll patients at least 18 years of age who are undergoing radiation therapy alone or in combination with chemotherapy. Subjects will be randomized 1:1 to prophylactic hydroxychloroquine or placebo. The primary endpoint is to compare the likelihood of symptomatic COVID-19 infection between the hydroxychloroquine and placebo groups. Secondary objectives are the likelihood of severe COVID-19 between groups, and to evaluate acute toxicity associated with administration of hydroxychloroquine during radiation or chemoradiation.

“Patients may be at a higher risk for contracting COVID-19 during cancer treatment due to increased exposure,” said Dr. Nancy Y. Lee, Vice Chairman, Department of Radiation Oncology at MSK and principal investigator on the clinical trial. “There is an urgent need to identify effective risk-reduction strategies for these patients that require treatment for their cancer as we await effective therapeutic options. This trial will provide important insight into the potential role that hydroxychloroquine might play in addressing this critical need.”

Hydroxychloroquine is a medication used for the prevention and treatment of certain types of malaria, as well as rheumatoid arthritis, lupus, and porphyria cutanea tarda, and is currently being evaluated in a variety of settings for its potential ability to prevent SARS-CoV-2 infection and to treat COVID-19.

“Patients undergoing cancer directed treatment represent a vulnerable population that is at high risk for COVID-19,” said Dr. Satya Chava, Chief Executive Officer of Laurus Labs Limited. “We are pleased to be working with the expert clinical researchers at Memorial Sloan Kettering to evaluate the prophylactic potential of this drug.”

Rising Pharmaceuticals -- and its partner Laurus Labs Limited in Hyderabad, India -- manufacture Hydroxychloroquine Sulphate, USP Tablets under an FDA approved drug application. Rising Pharmaceuticals and Laurus Labs have agreed to donate Hydroxychloroquine tablets to support MSK’s study.

About Hydroxychloroquine Sulfate, USP Tablets

Hydroxychloroquine sulfate tablets are indicated for the following; treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported; for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and for the treatment of acute and chronic rheumatoid arthritis in adults.

About Rising Pharma Holdings, Inc.

Rising Pharma Holdings, Inc., a privately held company, sells generic prescription products and over-the-counter pharmaceutical products under the Rising label to leading wholesalers, chain drug stores, distributors, and mass merchandisers. The company continually seeks new opportunities to develop its business through strategic partnerships with manufacturers, marketers, and distributors under the Rising label.

About Laurus Labs Limited

Laurus Labs Limited is a leading research driven Pharmaceutical Manufacturing Company in India. We have grown to become one of the leading manufacturers of API for Anti-Retroviral (ARV), Oncology, Cardiovascular, Anti-Diabetics, Anti-Asthma and Gastroenterology. We are thriving on growth opportunities in formulation manufacturing to service all leading markets of North America, Europe, and Low Middle-Income Countries (LMIC). We are driving growth opportunities in Contract Development and Manufacturing through our Synthesis business. Most of our manufacturing facilities are approved by major regulatory authorities USFDA, WHO-Geneva, UK-MHRA etc. Our approach remains to identify and invest ahead of time with strategic investments in State-of-the-Art R&D and Manufacturing Infrastructure enabling us to become a quality supplier of high-volume products. Corporate Identification No: L24239AP2005PLC047518