Hybridon Provides Updated Interim Results for the Phase 1 Trial of IMOxine(TM)
22 Noviembre 2004 - 7:00AM
PR Newswire (US)
Hybridon Provides Updated Interim Results for the Phase 1 Trial of
IMOxine(TM) - Safety and Immunological Activity Shown in Refractory
Cancer Patients Led to Previously Announced Initiation of Phase 2
Trial - CAMBRIDGE, Mass., Nov. 22 /PRNewswire-FirstCall/ --
Hybridon, Inc. (AMEX:HBY) today provided updated Phase 1 results
for IMOxine(TM), the Company's lead oncology drug candidate,
following the completion of enrollment in the trial. Twenty-three
patients with refractory solid tumors have enrolled in the study,
which is being conducted at the Lombardi Comprehensive Cancer
Center (LCCC) at Georgetown University Hospital. Based on these
encouraging interim results, Hybridon recently announced initiation
of a Phase 2 trial in renal cell carcinoma. "Patients with a
variety of cancer types have been studied in the Phase 1 trial,
including patients with renal cell carcinoma, melanoma, colorectal
cancer, sarcoma, breast cancer, non-small cell lung cancer, and
other cancers," said John L. Marshall, M.D., Director,
Developmental Therapeutics and Associate Professor of Medicine at
LCCC. "Over 250 total doses have been administered to these
refractory cancer patients. IMOxine was well tolerated with no
dose-limiting toxicity observed in the study. Immunological markers
have shown preliminary evidence of dose response effects." "The
clinical results to date of IMOxine safety, immune activity, and
incidence of stable disease, including these interim results, have
been extremely encouraging," said Tim Sullivan, Vice President of
Development Programs at Hybridon. "We anticipate initiation of
additional Phase 2 trials in 2005." Hybridon had previously
announced in May 2004 its intention to expand the Phase 1 trial
with additional melanoma or renal cell carcinoma patients. Based on
the interim results, the Company determined to move forward with a
Phase 2 study instead of expanding the Phase 1 trial. Presentations
of the complete Phase 1 data are expected to be made at scientific
meetings in 2005. About the Phase 1 Oncology Trial The trial is
designed to evaluate the safety and immunopharmacology of IMOxine
as a monotherapy in patients with refractory solid tumors that had
been classified as progressive disease in spite of multiple courses
of prior therapies. IMOxine is administered as a monotherapy once a
week by subcutaneous injection at dosages of 0.04, 0.16, 0.32,
0.48, or 0.64 mg/kg/week. Treatment duration is open-ended, based
on safety and radiology assessment of tumor status at 8-week
intervals. Immunopharmacological assessments performed after the
first and third doses include ELISA measurement of serum cytokines
(IL-6, IL-10, IL-12, tissue necrosis factor- alpha,
interferon-alpha, and interferon-gamma) and flow cytometric
analysis of surface markers on circulating leukocytes (total and
activated populations), in addition to hematology. Nineteen of the
23 patients completed at least four consecutive weeks of treatment
to fulfill the safety evaluation requirements of the protocol. The
four early withdrawals occurred due to disease progression.
Seventeen patients were assessed for disease status by radiology
and clinical evaluation after eight weeks of treatment, and nine of
these patients were determined to have stable disease. Six of the
nine stable-disease patients were re-assessed after 16 weeks of
treatment, and 4 continued to maintain stable disease. Two patients
continued treatment to the 32-week disease status assessment and
both were stable radiologically, although one patient was withdrawn
after 32 weeks due to symptomatic deterioration. One patient with
metastatic renal cell carcinoma continues into the 11th month of
treatment, with maintenance of stable disease at the Week 40
evaluation. Adverse effects recognized to date have been consistent
with the expected immune stimulation activity of IMOxine, and
primarily have been mild to moderate injection site reactions of
erythema and induration, pain, and "flu- like" symptoms
(rigors/chills, fever, nausea, myalgia, headache, malaise, and
fatigue). Observations that were considered serious adverse events
and possibly related to IMOxine treatment have been: transient
hypoxia, dyspnea, and rigors/chills 1 hour post-dose (1 patient);
abdominal pain with nausea/vomiting (1 patient); and anemia
requiring transfusion (2 patients). Monitoring of the database is
not yet complete. About IMOxine IMOxine is a 2nd-generation
immunomodulatory oligonucleotide (IMO(TM)) that functions as an
agonist of Toll-like Receptor 9 (TLR9), a specific protein receptor
in certain cells of the immune system. Other receptors also may
play a role in the immune system response to IMOxine. TLR9 is shown
to recognize bacterial DNA and induce a defensive immune response,
producing a Th1 type cytokine profile that allows modulation of
host innate and adaptive immune responses. TLR9 is expressed on
human plasmacytoid dendritic cells and B lymphocytes. IMOxine and
its murine analogue have been studied in a variety of preclinical
tumor models, as monotherapy and in combinations with selected
chemotherapeutic agents and monoclonal antibodies, and with
radiation. We also have studied IMOxine (also known as HYB2055 for
Injection) in a Phase 1 trial in healthy subjects at weekly
subcutaneous dosages of 0.005 to 0.16 mg/kg/week. The healthy
volunteer trial evaluated safety and immunological activity by
monitoring serum cytokines, leukocyte phenotyping, and various
clinical laboratory parameters. About Hybridon Hybridon, Inc. is a
leader in the discovery and development of novel therapeutics based
on synthetic DNA. The Company's focus is to develop therapeutics
independently and with partners based on two proprietary technology
platforms: i) Synthetic immunomodulatory oligonucleotide (IMO(TM))
motifs that act to modulate responses of the immune system; and ii)
Antisense technology that uses synthetic DNA to block the
production of disease-causing proteins at the cellular level. The
Company is conducting clinical trials in oncology patients with
HYB2055 (IMOxine(TM)), a 2nd-generation IMO, and with GEM(R)231, a
2nd- generation antisense oligonucleotide targeted to protein
kinase A, in combination with irinotecan. Hybridon also is
collaborating on development of additional second-generation
antisense oligonucleotides for the treatment of cancer and viral
infections, and has completed a Phase 1 trial of HYB2055 in healthy
volunteers. Hybridon has licensed Amplivax(TM) (an adjuvant
application of HYB2055) as an adjuvant for IR103, a potential
therapeutic and prophylactic vaccine for HIV infection being
developed by The Immune Response Corporation. This press release
contains forward-looking statements concerning Hybridon that
involve a number of risks and uncertainties. For this purpose, any
statements contained herein that are not statements of historical
fact may be deemed to be forward-looking statements. Without
limiting the foregoing, the words, "believes," "anticipates,"
"plans," "expects," "estimates," "intends," "should," "could,"
"will," "may," and similar expressions are intended to identify
forward-looking statements. There are a number of important factors
that could cause Hybridon's actual results to differ materially
from those indicated by such forward-looking statements, including
risks as to whether results obtained in preclinical studies or
early clinical trials, such as the interim results referred to
above, will be indicative of results obtained in future preclinical
studies or clinical trials, or final clinical trial results, or
warrant further clinical trials and product development; whether
the Company will be able to enter into additional site agreements
or recruit patients on a timely basis; whether products based on
Hybridon's technology will advance through the clinical trial
process and receive approval from the United States Food and Drug
Administration or equivalent foreign regulatory agencies; whether,
if such products receive approval, they will be successfully
distributed and marketed; whether the patents and patent
applications owned or licensed by Hybridon will protect the
Company's technology and prevent others from infringing it; whether
Hybridon's cash resources will be sufficient to fund product
development; and such other important factors as are set forth
under the caption "Risk Factors" in Hybridon's Quarterly Report on
Form 10-Q filed on November 14, 2004, which important factors are
incorporated herein by reference. Hybridon disclaims any intention
or obligation to update any forward-looking statements. Contacts:
Hybridon, Inc. Euro RSCG Life NRP 617-679-5500, x5526 212-845-4268
Tim Sullivan, Ph.D. Robert Stanislaro (media) E-mail: 212-845-4269
Brian Ritchie (investors) Georgetown University Medical Center
Lindsey A. Spindle 202-687-5100 DATASOURCE: Hybridon, Inc. CONTACT:
Tim Sullivan, Ph.D. of Hybridon, Inc., +1-617-679-5500, ext. 5526,
; or Lindsey A. Spindle of Georgetown University Medical Center,
+1-202-687-5100, ; Media - Robert Stanislaro, +1-212-845-4268,
Investors - Brian Ritchie, +1-212-845-4269, both of Euro RSCG Life
NRP, for Hybridon, Inc. Web site: http://www.hybridon.com/
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