On February 20, 2018, the Company announced the successful achievement of the primary
endpoint in its CD02 Phase 2b/3 pivotal clinical trial with PRO 140 in combination with existing antiretroviral therapy (ART) in patients failing their current HIV therapy. The trial data show a statistically significant reduction in
HIV-1 RNA viral load of greater than 0.5log with PRO 140 versus placebo.
This multicenter clinical trial enrolled 52 patients with CCR5-tropic HIV-1 and
documented genotypic or phenotypic resistance to ART drugs within three drug classes or within two or more drug classes with limited treatment options. Enrolled patients all had plasma HIV-1 RNA
³
400
copies/mL and documented detectable viral load within three months prior to the screening visit. In the
one-week,
randomized, double-blind, placebo-controlled portion of the trial, all trial patients received
their existing ART therapy, with one-half of the enrolled patients administered a 350mg subcutaneous injection of PRO 140 and the other half receiving a subcutaneous injection of placebo.
The trials primary endpoint was the proportion of participants with greater than 0.5log reduction in HIV-1 RNA viral load from baseline at the end of
the one-week treatment period. At one week, patients in the PRO 140 arm showed a statistically significant reduction in HIV-1 RNA viral load of greater than 0.5log from baseline versus patients in the placebo arm (p<0.01). Following this
one-week
period, all patients continue in the trial for an additional 24 weeks with PRO 140 weekly subcutaneous injections and optimized ART.
Forward-Looking Statements
This Current Report on Form
8-K
contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding the Companys current and proposed trials and
studies and their enrollment, results, costs and completion. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends,
estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is
not forward-looking. The Companys forward-looking statements are not guarantees of performance and actual results could differ materially from those contained in or expressed by such statements. In evaluating all such statements, the Company
urges investors to specifically consider the various risk factors identified in the Companys Form
10-K
for the fiscal year ended May 31, 2017 in the section titled Risk Factors in Part
I, Item 1A, any of which could cause actual results to differ materially from those indicated by the Companys forward-looking statements.
The
Companys forward-looking statements reflect its current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans. Investors should
not place undue reliance on the Companys forward-looking statements, which are subject to risks and uncertainties relating to, among other things: (i) the sufficiency of the Companys cash position and the Companys ongoing
ability to raise additional capital to fund its operations, (ii) the Companys ability to complete its Phase 2b/3 pivotal combination therapy trial for PRO 140 (CD02) and to meet the FDAs requirements with respect to safety and
efficacy to support the filing of a Biologics License Application, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to identify patients to enroll in its clinical trials in a timely
fashion, (v) the Companys ability to achieve approval of a marketable product, (vi) design, implementation and conduct of clinical trials, (vii) the results of the Companys clinical trials, including the possibility of
unfavorable clinical trial results, (viii) the market for, and marketability of, any product that is approved, (ix) the existence or development of vaccines, drugs, or other treatments for infection with the Human Immunodeficiency Virus
that are viewed by medical professionals or patients as superior to the Companys products, (x) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xi) general economic and business
conditions, (xii) changes in foreign, political, and social conditions, and (xiii) various other matters, many of which are beyond the Companys control. Should one or more of these risks or uncertainties develop, or should underlying
assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by the Companys forward-looking statements.
The Company intends that all forward-looking statements made in this Current Report on Form
8-K
will be subject to the
safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act of 1933, as amended, to the extent applicable. Except as required by law, the Company does not undertake any responsibility to update these
forward-looking statements to take into account events or circumstances that occur after the date of this Current Report on Form
8-K.
Additionally, the Company does not undertake any responsibility to update
investors upon on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.