- CytoDyn
signs definitive agreement to acquire privately held ProstaGene
- Gets
access to CCR5 technologies related to cancer
- Lead
candidate PRO 140 set for Investigational New Drug (IND) application in
first cancer indication, expanding CytoDyn’s focus beyond HIV
With its planned acquisition of ProstaGene, LLC, CytoDyn
Inc. (OTCQB: CYDY) is expanding its focus beyond HIV and graft-versus-host
disease to open up a new front in the fight against cancer. ProstaGene is
developing metastasis control technology that targets the chemokine receptor
type 5 (CCR5), a protein on the surface of white blood cells. Metastasis is the
spread of cancer beyond the original tumor, a phenomenon that contributes to
the disease’s deadliness. Studies have suggested that the use of CCR5
antagonists as adjuvants may bolster anti-tumor immune responses.
CytoDyn recently announced signing a definitive agreement to
acquire privately held ProstaGene, expected to be finalized in November.
CytoDyn also confirmed that Richard G. Pestell, M.D., Ph.D., M.B.A., F.A.C.P.,
F.R.A.C.P., founder and CEO of ProstaGene, will join CytoDyn as its future
chief medical officer (http://ibn.fm/QOBNu).
The deal transfers or assigns certain intellectual property rights held by
ProstaGene and Pestell to CytoDyn. Of particular interest to CytoDyn is
the metastasis control technology and the work done in this area by ProstaGene
aimed at developing a therapy that prevents metastasis in prostate, breast and
other cancers. ProstaGene is also developing a companion test to identify those
patients who will respond to the therapy, estimated at around 50 percent of
prostate and breast cancer cases, resulting in the potential for an extensive
market. Both the metastasis technology and IP are based on blocking the CCR5
receptor from antigens.
CCR5 is also thought to act as a portal for many forms of
the human immunodeficiency virus (HIV) that causes acquired immunodeficiency
syndrome, or AIDS, which is why it has been of interest as a drug target to
CytoDyn. The normal function of CCR5 is to bind chemokines, molecules that
regulate inflammation. However, the receptor can also provide a gateway to HIV;
the GP120 protein of HIV first attaches to the CD4 receptor on the cell
membrane and then is able to bind to the co-receptor CCR5. Fusing of the membranes
of the virus and the immune cell then occurs and genetic material from HIV
enters the cell, infecting the cell.
CytoDyn’s lead product candidate, PRO 140 (leronlimab),
targets CCR5. PRO 140 is a viral-entry inhibitor, a new class of HIV/AIDS therapies
that works by blocking the entry of the virus to healthy cells. PRO 140 works
by attaching to the same portion of the CCR5 co-receptor to which HIV normally
binds. The PRO 140 antibody physically blocks HIV from attaching to the CCR5
co-receptor and arrests the completion of the second step in the entry process.
The HIV is, consequently, rendered ineffective.
CytoDyn has completed a Phase 3 study of PRO 140 in
combination with current highly active anti-retroviral therapy (HAART)
regimens, and it plans to file a Biological License Application for that usage.
The company is also conducting a Phase 3 study of PRO 140 as a potential
single-agent treatment for HIV.
The company recently received approval to increase the
dosage in its Phase 3 monotherapy trials of PRO 140. Due for completion by
year-end (http://ibn.fm/pMGdn),
“patients who finish the study will move into a FDA-cleared rollover study.”
The approach taken by PRO 140 has a distinct advantage over
other therapies. Other HIV drugs that target CCR5 interact with the pocket of
the receptor and thereby inhibit binding of not only the HIV, but chemokines,
which may have a number of adverse consequences because of the disruption of
the chemokine inflammatory response. However, PRO140 blocks entry of the HIV
and yet permits normal chemokine binding, leading to potentially fewer side
effects.
CytoDyn is now preparing to move PRO 140 into clinical
trials in cancer. In August, CytoDyn announced that PRO140 had been shown
effective at inhibiting the growth of a human colon carcinoma cell line (SW480)
in a prominent mouse model. The results were statistically significant and
provide the basis for filing an Investigational New Drug (IND) application with
the U.S. Food and Drug Administration (FDA) for a clinical trial in colon
carcinoma patients (http://ibn.fm/tIEYt).
For more information, visit the company’s website at www.CytoDyn.com
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