NYMOX Successfully Achieves Manufacturing Scale-Up
June 07 2018 - 9:30AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to report
that manufacturing scale-up milestones have been reached for the
Company's lead compound Fexapotide Triflutate (FT). Over the
past year, the Company has worked intensively for its lead-drug
scale-up of the manufacturing batches in anticipation of regulatory
filings and clearances of FT for the millions of men suffering from
prostate enlargement (BPH). The Company has now
successfully and significantly increased the batch size and
yield for the sterile injectable drug. As a result of the
successful scale-up, the
Company has also significantly augmented
its inventory of fully validated drug and
potentially marketable inventory. The recently
achieved scale-up (by a factor of >10X) allows for realistic
expansion of marketing plans for FT in major world markets.
Marketing requires approvals from regulatory authorities, which has
not yet been granted.
The scaled up sterile injectable
FT (finished product) is manufactured as a lyophilized
powder which has excellent shelf life when stored at room
temperature, frozen or refrigerated.
"We are very excited by the achievement of these
key results, and we anticipate that these new manufacturing
milestones will allow for wider marketing plans to now become
considerably more practically feasible," said Dr. Paul Averback,
CEO of Nymox.
Dr. Suresh Kalbag, Nymox head of chemistry and
manufacturing operations, stated: “To successfully achieve
manufacturing scale-up, is no trivial task for any pharmaceutical
product. The process is inherently associated with unknown risks
and challenges. We are therefore extremely pleased with the team’s
achievement and accomplishment over this past year and that we were
able to successfully execute this critical project on time and
within budget.”
Nymox also announced today an additional
$2,000,000.00 in funding from a long-term shareholder. The funding
was done at $3.00 per share and there were no fees incurred in the
transaction. The additional funding brings the recent net funding
total to 18.25 million USD. Treasury funding of 16.25 million USD
from qualified long-term investors was announced recently on April
12, 2018.
Nymox's lead drug Fexapotide has been in
development for over 10 years and has been tested by expert
clinical trial investigative teams in over 70 distinguished
clinical trial centers throughout the US, and has been found after
7 years of prospective placebo controlled double blind studies of
treatment of 995 U.S. men with prostate enlargement to not only
show clinically meaningful and durable relief of BPH symptoms, but
also to show a major reduction in the incidence of prostate cancer,
compared to placebo and compared to the known and expected normal
incidence of the disease. The same clinical program has also shown
in a long-term blinded placebo group study an 82-95% reduction in
the number of these patients who required surgery after they
received Fexapotide in the trial, as compared to patients who
did not receive Fexapotide but instead later received conventional
approved BPH treatments (p<.0001).
For more information please
contact info@nymox.com or 800-936-9669.
Forward Looking Statements
To the extent that statements contained in this
press release are not descriptions of historical facts regarding
Nymox, they are forward-looking statements reflecting the current
beliefs and expectations of management made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995, including statements regarding the need for new options to
treat BPH and prostate cancer, the potential of Fexapotide to treat
BPH and prostate cancer and the estimated timing of further
developments for Fexapotide. Such forward-looking statements
involve substantial risks and uncertainties that could cause our
clinical development program, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the clinical drug development process, including the regulatory
approval process, the timing of Nymox's regulatory filings, Nymox's
substantial dependence on Fexapotide, Nymox's commercialization
plans and efforts and other matters that could affect the
availability or commercial potential of Fexapotide. Nymox
undertakes no obligation to update or revise any forward looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of Nymox in general, see Nymox's current
and future reports filed with the U.S. Securities and Exchange
Commission, including its Annual Report on Form 20-F for the year
ended December 31, 2017, and its Quarterly Reports.
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