CytoDyn Inc (OTCMKTS:CYDY) said Tuesday that its new lab in Philadelphia led by the company’s chief medical officer Professor Richard G Pestell will conduct eight pre-clinical studies on melanoma, pancreatic cancer, breast cancer, prostate cancer, colon cancer, lung cancer, liver cancer and stomach cancer.
As part of CytoDyn's recent acquisition of ProstaGene, CytoDyn received control of a prestigious lab that operates under the guidance of Dr Pestell who is an authority in cancer research. CytoDyn pegged the cost of running the preclinical studies for the eight cancers and submission of Phase 2 IND applications at approximately $1.5 million.
"We believe CytoDyn's model to concurrently evaluate several opportunities in pursuit of multiple Phase 2 clinical trials in cancer, if the animal studies are positive, may represent a significant acceleration to create therapeutic benefit for cancer patients," said CytoDyn CEO Dr Nader Pourhassan in a statement.
Separately, CytoDyn announced Friday that it held a productive meeting with the US Food and Drug Administration (FDA) in which it won key concessions for its flagship HIV drug leronlimab.
On a recent conference call with the FDA, US regulators recognized that the higher dosage of 700mg in a monotherapy trial for leronlimab, an injectable antibody which takes aim at HIV, had a much higher response rate than the 350mg dose used in a combination therapy trial.
"Exploring these opportunities with our new laboratory will not slow down the filing of our Biologics License Application (BLA) or our monotherapy trial for HIV patients,” said Pourhassan. “We are also delighted that we have entered into discussions for commercializing leronlimab in 2020 and are currently considering a potential offer for royalties and milestone payments in connection with a commercialization partnership for HIV and GvHD indications."
To avoid a delay in the filing of the drug’s Biologics License Application (BLA) submission, the FDA has agreed to accept safety data from 100 patients in the monotherapy trial with the 700mg dose of leronlimab. This concession allows for the drug’s BLA submission for the combination therapy to use 700 mg of the drug instead of the original 350 mg dose.
Leronlimab is an injectable antibody that shows promise as an anti-viral agent with fewer side effects, lower toxicity and less frequent doses than daily therapies now in use for the treatment of HIV. The target of leronlimab is CCR5, a cell receptor that is the entry point for most strains of the human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS).
"The receptor, CCR5, has been shown to function as a lynchpin in both the progression of cancer metastasis and HIV," said Dr Pestell. "Most cancer deaths are linked to the metastasis not the primary tumor. Cancer can use CCR5 to spread the disease. Cancer metastasis has been reduced in animal studies and human pilot studies using CCR5 small molecule inhibitors. Leronlimab has a track record of safety, without serious adverse events related to leronlimab in over 670 patients from the HIV community.”
Contact Uttara Choudhury at [email protected]