Current Report Filing (8-k)
July 22 2014 - 4:21PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
July 16, 2014
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NORTHWEST BIOTHERAPEUTICS, INC. |
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(Exact name of registrant as specified in its charter) |
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Delaware |
0-33393 |
94-3306718 |
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer ID Number) |
4800
Montgomery Lane, Suite 800, Bethesda, Maryland |
20814 |
(Address of
principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code |
(240) 497-9024 |
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. Other Events.
On July 16, 2014, Northwest Biotherapeutics,
Inc. issued a press release reporting that the Phase I portion of the Company's Phase I/II DCVax-Direct clinical trial has
completed its 36-patient target recruitment, and the Company is now underway with preparations for the Phase II portion of this
trial, as well as expansion of DCVax-Direct manufacturing.
Item 9.01. Financial Statements and Exhibits.
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Exhibit No. |
Description |
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99.1 |
Press Release of Northwest Biotherapeutics, Inc. dated July 16,
2014. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act
of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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NORTHWEST BIOTHERAPEUTICS, INC. |
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Date: July 22, 2014 |
/s/ Linda
Powers |
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Linda Powers, Chief Executive Officer and Chairman |
Exhibit 99.1
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Northwest |
t (240) 497-9024 |
www.nwbio.com |
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Biotherapeutics, Inc. |
f (240) 627-4121 |
NASDAQ: NWBO |
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4800 Montgomery Lane |
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Suite 800 |
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Bethesda, MD 20814 |
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NW BIO ANNOUNCES COMPLETION OF
DCVAX®-DIRECT PHASE I TRIAL RECRUITMENT
DCVax®-Direct Phase II Trial Preparations
and Manufacturing Expansion Underway
BETHESDA, Md., July 16, 2014 - Northwest Biotherapeutics (NASDAQ:
NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced
today that the Phase I portion of the Company's Phase I/II DCVax-Direct clinical trial has completed its 36-patient target recruitment,
and the Company is now underway with preparations for the Phase II portion of this trial, as well as expansion of DCVax-Direct
manufacturing.
The Phase I/II trial is testing the safety and activity of DCVax-Direct
in various types of cancer. The Phase I portion of the trial has involved testing of 3 different dose levels, and a diverse range
of cancers. The patients enrolled in Phase I will continue to receive treatments in accordance with the protocol.
With the closing of Phase I, the Company is now preparing to
initiate the Phase II portion of the trial. This second part of the Phase I/II study will target 24 or more patients in selected
cancers. Additional trial sites are being brought on to facilitate and expedite enrollment.
The Company and its manufacturing partner, Cognate BioServices,
are also expanding the manufacturing capacity for DCVax-Direct. During the last two years, in addition to manufacturing the
DCVax-Direct products for the clinical trial, Cognate has undertaken development work for the DCVax-Direct program, and the automated
system used in certain key stages of DCVax-Direct production, in order to build the foundation for this expansion of manufacturing
capacity.
"It is very gratifying to reach this important milestone in the Phase I portion of the Phase I/II
DCVax-Direct clinical trial," commented Linda Powers, CEO of NW Bio . "We are looking forward to proceeding with Phase
II, with anticipated expansion of the clinical trial sites and expanded manufacturing capacity and automation efficiencies."
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology
company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities
of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company
has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 312-patient Phase
III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and
is an "orphan disease." The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable
solid tumor cancers. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate
cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of
Pennsylvania. In Germany, the Company recently received approval of a 5-year Hospital Exemption for treatment of glioma (brain
cancer) patients outside the clinical trial.
Disclaimer
Statements made in this news release that are not historical
facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect,"
"believe," "intend," "design," "plan," "continue," "may," "will,"
"anticipate," and similar expressions are intended to identify forward-looking statements. Actual results may differ
materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that
could cause actual results to differ materially from those anticipated, such as risks related to the Company's ability to enroll
patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties
about the timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy,
risks related to the Company's and Cognate's abilities to carry out the intended manufacturing expansions, risks related to the
Company's ongoing ability to raise additional capital, risks related to the Company's ability to carry out the Hospital Exemption
program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including
Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC")
filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause
actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance
on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result
of new information, future events or developments, except as required by securities laws.
Media Contacts:
Les Goldman 202-841-7909 |
Beverly Jedynak 312-943-1123 |
lgoldman@nwbio.com |
bjedynak@janispr.com
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