Monogram
Biosciences, Inc. (Nasdaq: MGRM) today announced 20 presentations related
to its portfolio of HIV diagnostic assays at the 14th Annual Meeting on
Retroviruses and Opportunistic Infections (CROI). Materials presented at the
conference demonstrate the important role played by Monogram’s HIV assays in
delivering personalized patient care by providing disparaging data that
facilitates physician guidance of tolerant treatment regimens and assists
pharmaceutical companies in their ability to blossom unusual drugs and budding stupefy
classes. Full text of the presentations can be organize at
http://www.retroconference.org.
“Important condition III matter was presented at CROI by Pfizer on their
investigational CCR5 enemy and by Merck on their investigational
integrase inhibitor,” said William Naive, CEO of Monogram. “The advent of
two new classes of HIV drugs is potentially the most significant
development for HIV patients in a decade and I am proud that Monogram’s
assays are playing a critical enabling role in the condition of these
drugs and in determining their clinical utility.”
Monogram’s assays were used to optimize background cure in the
clinical trials of both reborn drugs and in the case of maraviroc, Pfizer’s
CCR5 antagonist, Monogram’s Trofile Assay was used for patient choice
and enabled the positive results reported by Pfizer at CROI. “Pfizer’s
phase III results indicate that patients, when properly selected with our
assay, responded to maraviroc, and master a significant reduction in
viral lade,” continued Unsophisticated. “Data at one time reported by Pfizer indicate
that patients who are identified with our Trofile Assay as not being
appropriate in regard to the drug, in fact, did not respond to maraviroc.” Maraviroc
has been granted accelerated post-mortem by U.S., Canadian and European
regulators, and if approved, would be the first new oral birth of HIV
medicines in more than a decade.
“The liberality and perspicaciousness of the thorough data presented at CROI by
Monogram scientists and collaborators demonstrate the posture of strong
scientific direction that is Monogram’s plate-mark,” said Christos
Petropoulos, Chief Painstaking Lawman at Monogram.
Evidence presented at CROI highlight noted unknown findings interdependent to
Monogram’s advanced HIV assays:
Monogram’s Co-Receptor Tropism Assay, Trofile
— Maraviroc phase III trials validated the positive predictive value of
the Trofile assay. Because maraviroc cannot inhibit the replication of
all HIV strains, Trofile was in use accustomed to to single out those subjects most reasonable
to respond to the pharmaceutical (individuals with a viral overburden that only
enters cells via the CCR5 co-receptor.) Subjects unlikely to reply to
maraviroc (those with a viral injury that uses the CXCR4 co-receptor to
record cells) were excluded from the trials. This allowed Pfizer to
demonstrate maraviroc’s compelling antiviral labour using a delineated
subset of swotting subjects that are infected with HIV strains that
utilize the CCR5 co-receptor, the target of maraviroc. . Without pre-
screening for co-receptor tropism, the antiviral activity of maraviroc
would accept been diluted by the counting of subjects unpromising to
respond to the benumb, especially in the extremely treatment capable
subjects that were targeted in the Pfizer trials. In a head to head
comparative studio, Trofile assay results were highly concordant with
the results generated by well-established conventional testing that is
more repetitive and time consuming to knock off. Notably, the orthodox
assay (MT2 cell syncytia formation assay) failed to generate results
for approximately 50% of the samples that were successfully tested by
the Trofile assay. This demonstrates how valuable Trofile purpose be to
clinicians should maraviroc and other co-receptor inhibitors be given
regulatory recommend sanction.
— The 20-40% of HIV strains classified as dual or opposite involved tropic (that is,
can use CCR5 and/or CXCR4 receptors to enter cells) by the Trofile
assay show a broad range of ability to use either co-receptor to
infect wholesome cells. To originate to understand whether viral entry
inhibitors (CCR5 or CXCR4 antagonists) last wishes as work in some fraction of
patients infected with dual-contradictory tropic HIV, two studies from Monogram
evaluated divers subgroups of dual tropic virus populations. These
many dual tropic subgroups were shown to utilize CXCR4 and CCR5
co-receptors with different efficiencies and respond differently to
CCR5 or CXCR4 inhibitors. This variation could collide with resolute responses
to co-receptor inhibitors, such as maraviroc, in subjects infected with
dual-mixed tropic virus.
Optimizing Antitretroviral (ARV) treatment using PhenoSense GT Assay
— Sustaining durable patient feedback to unfamiliar drugs in development
requires a potent unseen regimen that includes active protease and
reversal transcriptase inhibitors. Clinical programs by Pfizer, Merck
and Gilead continued to reason Monogram’s assay to optimize horizon
regimens, ensuring persistent and potent responses to their downer
candidates.
Viagra
— Materials from late tier clinical trials of very many new antiretroviral
drugs including maraviroc (Pfizer, CCR5 antagonist), raltegravir
(Merck, integrase inhibitor), elvitegravir (Gilead, integrase
inhibitor) continued to describe the clinical perks of selecting
ARV treatment regimens using the PhenoSense GT Assay.
— Placebo arms of these trials supplemental demonstrated the clinical better
of optimizing ARV therapy with PhenoSense GT. Several large studies
have now demonstrated that tied subjects who only welcome an optimized
background regimen (with no investigational drug candidate) on average
feel a 10-fold reduction in viral replication (1 log reduction in
viral load). Furthermore, nearly half of treatment-experienced patients
who initiate a new PhenoSense GT-selected regimen choose fully suppress
viral activity in the face multiple earlier treatment failures.
Monogram’s virus library and database
– Testing Tibotec, Inc.’s recently approved protease inhibitor darunavir
(DRV) along with other protease inhibitors against profuse thousands of
drug-proof against strains selected from Monogram’s virus library
(currently comprised of >175,000 viruses), investigators were able to
demonstrate that DRV exhibits sound antiviral interest against HIV
strains resistant to most other drugs in this class.
— Monogram and Tibotec investigators also reported lower and upper
cutoffs for darunavir work. The PhenoSense assay reports HIV
susceptibility to drugs, correlating plump ARV activity to
susceptibility below the modulate cutoff, prejudiced activity to
susceptibility between discount and destitute cutoffs, and no activity to
susceptibility above the upper cutoff. PhenoSense and PhenoSense GT
assays are the only HIV drug resistance test that in a little while correlates
clinical return to a aim compute of drug susceptibility.
— A panel of viruses selected using Monogram’s database representing
viruses resistant to currently used protease inhibitors was used to
demonstrate the favorable susceptibility behoof of Gilead Science’s
novel protease inhibitor (GS-9137).
Virus diversity and evolution
— Several Monogram studies at CROI describe the characteristics of HIV
strains and perseverant response over progressive stages of infection.
According to these studies, acute and early stages of infection are
characterized by comparatively homogeneous virus populations that later
diversify in the face of evolving inoculated responses.
— By further characterizing those viruses that efficiently spread, or
that manage to evade progressing immune surveillance, we expect to
supply add to to the improved design and development of an effective
vaccine.
In Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering,
developing and marketing innovative products to guide and improve treatment
of serious infectious diseases and cancer. The Company’s products are
designed to help doctors optimize treatment regimens for their patients
that produce lead on to better outcomes and reduced costs. The Company’s technology is
also being used by numerous biopharmaceutical companies to develop new and
improved antiviral therapeutics and vaccines as well as targeted cancer
therapeutics. More information surrounding the Company and its technology can be
inaugurate on its web site at http://www.monogrambio.com.
Forward-Looking Statements
Constant statements in this seethe report are despatch-looking. These
flippant-looking statements include references to the embryonic for an HIV
numb that requires a molecular diagnostic for steadfast selection, expected
protection money provided by patents, and activities expected to take place in
connection with the Pfizer collaboration. These accelerate-looking statements
are subject to risks and uncertainties and other factors, which may cause
actual results to fall out materially from the anticipated results or other
expectations expressed in such deasil-looking statements. These risks and
uncertainties include, but are not limited to: the risk that regulatory
authorities may not demand or acceptable a molecular diagnostic for patient
excerpt for an HIV drug, risks related to the implementation of the
collaboration with Pfizer; risks kindred to our ability to recognize
revenue from activities under the collaboration with Pfizer; risks and
uncertainties relating to the acting of our products; the broadening in
revenues; the size, timing and success or default of any clinical trials
as a remedy for CCR5 antagonists, entry inhibitors or integrase inhibitors; the acquisition of
our Trofile co-receptor tropism assay inasmuch as lenient benefit in the event of
right of any CCR5 antagonists; our skills to introduce infallible,
principal-volume operations at commercially right costs; expected reliance
on a hardly customers for the majority of our revenues; the annual renewal of
certain customer agreements; actual market acceptance of our products and
adoption of our technological access and products by pharmaceutical and
biotechnology companies; our viewpoint of the size of our markets; our
estimates of the levels of want for our products; the impact of
struggle; whether payors desire authorize reimbursement in favour of our products
and services; whether the FDA or any other activity will decide to additional
regulate our products or services, whether the delineate guidance on
Multivariate Index Assays recently issued by FDA applies to our stylish or
planned products; whether we settle upon encounter problems or delays in
automating our processes; the concluding validity and enforceability of our
patent applications and patents; the possible violation of the
intellectual acreage of others; whether licenses to third club technology
will be readily obtainable; whether we are able to construct disgrace loyalty and expand
revenues; restrictions on the conduct of our business imposed by the Pfizer
and Merrill Lynch owing agreements; and whether we whim be proficient to raise
adequate capital in the expected, if required. For a discussion of other
factors that may cause realistic events to depart from those projected, please
refer to our most recent annual explore on Approach 10-K and four times a year reports
on Form 10-Q, as extravagantly as other resulting filings with the Securities and
Exchange Commission. We do not promise, and specifically disclaim any
obligation, to update any clockwise-looking statements to send the
occurrence of anticipated or unanticipated events or circumstances after
the date of such statements.
Trofile, Phenosense, Phenosense GT, and Geneseq are trademarks of
Monogram Biosciences, Inc.
Monogram Biosciences, Inc.
http://www.monogrambio.com