Rising Pharmaceuticals, Laurus Labs to Support a Phase 2 Randomized Clinical Trial of Hydroxychloroquine for Prophylaxis Against COVID-19 in Patients Receiving Cancer Therapy
7 May 2020 - - US-based Rising Pharma Holdings, Inc., operating as Rising Pharmaceuticals, has donated Hydroxychloroquine tablets in support of a Phase 2 randomised clinical trial exploring hydroxychloroquine as preventive treatment for coronavirus disease 2019 (COVID-19) in patients with cancer who are receiving radiation therapy, the company said.

The trial is being conducted at Memorial Sloan Kettering Cancer Center, a leader in cancer care. The randomised, 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 randomised 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.

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.

Rising Pharmaceuticals, and its partner Laurus Labs Ltd. 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.

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.

Rising Pharma Holdings 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.

Laurus Labs is a research driven Pharmaceutical Manufacturing company in India.