BUFFALO GROVE, Ill., Jan. 23, 2015 (GLOBE NEWSWIRE) -- RestorGenex Corporation (OTCQB:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, announced that it presented scientific data on RES-529 for the treatment of glioblastoma multiforme (GBM) at the Keystone Symposia Series on PI 3-Kinase (PI3K) Signaling Pathways. The presentation titled "Validation of RES-529, a novel TORC1/TORC2 allosteric dissociative PI3K inhibitor in glioblastoma multiforme" was presented on January 16, 2015. RES-529 is a proprietary first-in-class PI3K/Akt/mTOR pathway inhibitor that is capable of dissociating both TORC1 and TORC2.
"The data presented help to understand the use of RES-529 and the validity of targeting the TORC1 and TORC2 protein complexes in a dissociative manner for GBM. This, and other work, supports the rationale for RestorGenex's plans to advance RES-529 into clinical trials in GBM," said David Sherris, Ph.D., chief scientific officer of RestorGenex.
The poster presentation discussed in vitro and in vivo data from preclinical studies evaluating RES-529 in GBM, a disease in which elevated expression of the PI3K is commonly seen. In the first study, RES-529 demonstrated an ability to inhibit signal transducers of the PI3K pathway that are controlled by TORC1 and TORC2. This mechanism was shown in a variety of tumor cells, including cells that have lost tumor suppressor PTEN.
In a second study, RES-529 was compared with two catalytic inhibitors of the PI3K pathway currently in the clinic; a combination PI3K/mTOR agent and a combination PI3K/Akt agent. In these experiments, RES-529 showed a 20 to more than 100 fold increase in activity above the other inhibitors. In addition, RES-529 was shown to inhibit tumor cell survival up to two orders of magnitude over that of a rapamycin analog PI3K inhibitor (TORC1 dissociative inhibitor approved by the FDA for select tumor types), in a tumor cell model known to show resistance to TORC1 inhibition.
A third study was presented that demonstrated RES-529 penetrates the blood-brain barrier. This was supported by efficacy data of RES-529 in an orthotopic GBM xenograft model where RES-529 showed an improvement in survival vs. control, similar to radiation treatment. When utilized in combination with radiation, RES-529 showed synergy extending survival above that of either RES-529 or radiation alone.
"GBM is a disease with a very poor prognosis. Less than 10% of newly diagnosed patients survive 5 years. Current standard of care extends overall survival only by approximately 13 to 15 months, and thus there is a clear unmet medical need for novel treatments to treat brain cancer," said Stephen M. Simes, chief executive officer of RestorGenex.
About RestorGenex Corporation
RestorGenex is a specialty biopharmaceutical company focused on developing a portfolio of first-in-class therapeutic products to treat diseases across the ophthalmologic, oncologic and dermatologic space. RestorGenex's lead product is a novel PI3K/Akt/mTOR pathway inhibitor which has completed two Phase I clinical trials for age-related macular degeneration and is in pre-clinical development for glioblastoma multiforme. The current pipeline also includes a "soft" anti-androgen compound for the treatment of acne vulgaris. RestorGenex's novel inhibition of the PI3K pathway and unique targeting of the androgen receptor show promise in a number of additional diseases, which the Company is evaluating for the purpose of creating safe and effective treatments and innovative therapies. For additional information please see: www.restorgenex.com.
Forward-Looking Statements
Certain statements in this release are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the clinical effectiveness and potential of RES-529, RestorGenex's plans to advance RES-529 into clinical trials in GBM and other statements that are not historical in nature, particularly those that utilize terminology such as "plans," "believe," "may," "intends," "expects," "future," "believes," "continue," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause RestorGenex's actual results to be materially different than those expressed in or implied by such forward-looking statements. Particular uncertainties and risks include, among others, uncertainties regarding uncertainties involved in clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, RestorGenex's ability to license out its existing products and technologies and license in additional products and technologies and the terms of such licenses; and other risks and uncertainties described in RestorGenex´s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K/A, subsequent quarterly reports on Form 10-Q and final prospectus dated July 31, 2014. All forward-looking statements in this release speak only as of the date of this release and are based on RestorGenex´s current beliefs and expectations. RestorGenex undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.