The challenge is keeping the virus under wraps. Then the challenge becomes the challenge in itself.
Every day, millions of HIV patients suffer from drug adverse effects and drug interactions that include anything from nausea and lethargy to rashes and fever. Some patients fail to recover their immune function, experience long-term morbidities (co-occurring diseases), develop drug resistance, or had to take maintenance medication. These, not to mention, living in fear that the condition would advance into the big “A,” affect patients’ quality of life.
The problem with HIV treatment adherence is that antiretroviral drugs, which prevent the infection from progressing to AIDS, need to be taken continuously and consistently. There’s no such thing as a “drug holiday” for patients with HIVand it remains a challenge for pharmaceutical companies to harness the power of all antiretroviral drugs into one potent drug that may someday be able to treat and prevent HIV without the need for supplementary medications. One company in Washington is paving the way for this new era in HIV research.
Enter Cytodyn Inc, (CYDY) a biotechnology company based in Vancouver, Washington that focuses on developing new therapies for combating immune deficiency viruses-related infections. The company is an industry leader in the development of subcutaneously-delivered humanized cell-specific monoclonal antibodies (mAbs)—antibodies cloned from a unique parent cell, usually from the spleen of mice—which guard against molecular entry of human immunodeficiency virus in healthy cells.
CytoDyn has concluded two Phase 2a(one in subcutaneous and the other intravenous) of its clinical trials for a new, humanized monoclonal antibody for treatment substitution therapies and is currently awaiting the U.S. Food and Drug Administration’s nod to enter Phase 2b of its clinical trials. Called PRO 140, the monotherapy module, has shown tremendous efficacy in terms of rapid and prolonged virus suppression for up to three weeks through intravenous and two weeks through subcutaneous (beneath the skin) administration. Phase 1 and Phase 2a of the PRO 140 clinical trials thus far have shown positive results, and if the same proves true for Phase 2b, PRO 140 could become the game changer HIV patients have long been waiting for in the fight against HIV and AIDS. Phase 2b seeks to prove the efficacy of PRO 140 monotherapy for antiviral maintenance among patients on combination antiretroviral therapy or HAART (highly active antiretroviral therapy).
Currently, HAART, a combination of three or more drugs, is the treatment modality that has effectively lowered the death rate among HIV positive patients by 70 percent. But, it is not without challenges. It is expensive; it can have serious adverse effects and,if not taken consistently, can lead to multi-drug resistance. If treatment is stopped the HIV virus begins replicating again, undermining the success of long term treatment.
If PRO 140 is successful in Treatment Substitution study, could offer multi-week replacement therapy for patients with HIV who wish or need to discontinue their HAART therapy temporarily.
The humanized IgG4 monoclonal antibody binds with CCR5, a chemokine receptor that regulates the entry and activity of immune cells that some HIV (about 65%) uses as a gateway to healthy cells. This categorizes PRO 140 as an entry inhibitor, because it blocks the passage of HIV into certain immune cells. Unlike existing entry inhibitors in the market, however, PRO 140 only has mild side-effects and does not block the normal function of CCR5. In other words, it lets CCR5 do its job while stopping the spread of HIV in the infected person’s body. PRO 140 is also expected to be cost-effective because despite its high potency and efficiency, it only needs to be administered weekly or bi-monthly whereas other products in the market have to be administered once or twice daily.
If CytoDyn’s Phase 2b Treatment Substitution study is successful it could see tremendous commercial opportunity as treatment substitution in HIV therapies. In a country where treated cases of HIV cases are estimated at over 604,000, the possibility that missed opportunities exist is certain. For example, patients who tested positive for HIV tropism for CCR5 account for 65% (390,400 patients). The cost of HAART for this many patients is about $7 billion.
CytoDyn has submitted the clinical trial protocol for Phase 2b in February and expects to conduct patient screenings very soon. It could start rolling out trials by May and evaluate results from June to September 2014.
Successful TS study could change the HIV paradigm. The company has raised over $20 million in market capital in the last 18 months. Composed of a world class team of scientists and experts with decades of experiences in life sciences, it aims to explore orphan drug designation and break through designation opportunities and revolutionize HIV therapeutics utilizing monoclonal antibodies.