BETHESDA, Md., Sept. 29, 2016 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology company developing DCVax® personalized immune
therapies for solid tumor cancers, announced that Dr. Marnix Bosch, Chief Technical Officer of NW
Bio, presented additional information relating to the DCVax®-Direct Phase I Trial in a poster presentation at the Second
CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, being held from
September 25th through September 28th in New York City.
Dr. Bosch's New York presentation, as well as his presentation at a cancer vaccines
conference in London last week, included information about estimated life expectancies for
individual patients (not for types of cancers or medians of groups of patients) based on a system developed and published
by Dr. Jennifer Wheler at MD Anderson Cancer Center. The Wheler system was based upon
clinical experience with 1,181 patients with diverse cancers at the MD Anderson Phase I Cancer Clinic (where most of the
DCVax-Direct Trial was conducted). Wheler validated and enhanced (with additional risk factors) a system for prediction of
individual-patient life expectancies previously developed by the Royal Marsden Hospital in the UK and well established in
the field.
A fundamental purpose of early stage exploratory trials, such as the DCVax-Direct Phase I trial, is to evaluate both product
characteristics and patient characteristics – and especially to identify which patients show the best responses to the
experimental product. Such evaluations enable later stage trials to be designed with more precision, to focus on the
patients who are the best fit for the experimental product and to potentially best demonstrate the performance of the
experimental product.
Exploratory trials typically involve diverse patient populations, as did the DCVax-Direct Phase I Trial. In evaluating
the results of such trials, it is especially helpful to be able to identify life expectancies for individual patients, and
compare those expectations to the actual results obtained in those individual patients. Patient-specific assessments are
still estimates, but are more precise than general assessments relating to types of cancer or medians of
groups of patients. Patient-specific assessments also can be more relevant, taking account of diversity among the
patients.
The DCVax-Direct Phase I Trial included more than a dozen different types of cancers, as well as sub-types (e.g., several
different types of sarcoma), patients with varying numbers of inoperable and locally advanced or metastatic tumors, and varying
numbers and types of prior treatment regimens that had all failed. This diversity enabled demonstration, in a wide range of
settings, of the safety and feasibility of DCVax-Direct (including feasibility of the novel intra-tumoral injections) as well as
an initial signal or indication of potential results.
As explained in Dr. Bosch's poster presentation, under the Wheler methodology individual life expectancy is determined through
measurements of 5 key risk factors: serum albumin, serum LDH, number of metastases, GI tumor, and ECOG (Eastern Cooperative
Oncology Group) performance status. The expected survival is 24.0, 15.2, 8.4, 6.2 or 4.1 months for patients with 0, 1, 2,
3 or 4-5 of the above risk factors, respectively.
Dr. Bosch's New York and London presentations applied the
Wheler system to determine estimated individual-patient life expectancies, and compare those to the actual clinical
results in each patient in the top 30% of patients in the DCVax-Direct Phase I Trial. Dr. Bosch's poster will be available
on the Company's website starting today.
The top 20% of the patients in the DCVax-Direct Phase I Trial have each exceeded 2 years of survival so far, and are still
alive. The longest survivor to date has reached nearly 3 years.
The top 30% of the patients in the DCVax-Direct Phase I Trial (including pancreatic, melanoma, lung, ovarian, sarcoma and
other cancers) have average actual individual survival to date of 26.7 months, compared with average expected individual survival
of 12.3 months.
The Wheler system for assessing individual patient life expectancies can be found at Wheler, et al.; Survival of 1,181
Patients in a Phase I Clinic: The MD Anderson Clinical Center for Targeted Therapy Experience. Clin. Cancer Res. 2012 May
15; 18(10): 2922–2929.
Dr. Bosch's presentation also included assessments of dendritic cell quality and their relationship with patient outcomes,
such as stabilization of disease and overall survival. The encouraging survival results correlate with underlying
mechanisms of action and cellular and immune profiles, including phenotype analyses, and relative production of a wide range of
cytokines by the dendritic cells. Additional positive observations include T-cell infiltration, and PD-L1 expression, with
64% of the patients evaluable for PD-L1 checkpoint expression (14 of 22) showing either de novo or significantly increased
expression of PD-L1 following DCVax-Direct treatment, indicating potential for combination of DCVax-Direct and checkpoint
inhibitors. Such information will also be helpful in shaping later stage trials.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed 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 348-patient Phase III trial in
newly diagnosed Glioblastoma multiforme (GBM), which is on a partial clinical hold in regard to new screening of patients. 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 types of inoperable solid tumors cancers. It has completed enrollment in the
Phase I portion of the trial. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer
together with the University of Pennsylvania. The Company previously received clearance from
the FDA for a 612-patient Phase III trial in prostate cancer. In Germany, the Company has
received approval of a 5-year Hospital Exemption for the treatment of all gliomas (primary brain cancers) 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 and uncertainties related to the
actions and decisions of Nasdaq, the Company's ongoing ability to raise additional capital, 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 including the actions and decisions of the FDA and other regulators, 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 and expansions contemplated in the Cognate Agreements,
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.
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SOURCE Northwest Biotherapeutics