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Calando Pharmaceuticals Collaborates with City of Hope to Initiate Investigator Sponsored Clinical Trial Using IT-101 in Lymphoma Patients.


PASADENA, Calif. -- Calando ca·lan·do  
adv. & adj. Music
With a gradual decrease in volume and often tempo. Used chiefly as a direction.



[Italian, present participle of calare, to slacken
 Pharmaceuticals, a majority-owned subsidiary majority-owned subsidiary

A firm in which more than 50% of outstanding voting stock is owned by the parent company.
 of Arrowhead Research Corporation (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:ARWR), announced today that it has entered into a collaboration with City of Hope in Duarte, CA to initiate an investigator sponsored clinical trial using Calando's nanoparticle drug candidate, IT-101, in patients with various forms of lymphoma.

The trial will be an open-label, phase II study of IT-101 intended to demonstrate safety and efficacy in patients with relapsed or refractory lymphoma, and will be preceded by a brief dose finding run-in phase. Patients with relapsed or refractory lymphoma, including B cell, T cell, and Hodgkin Lymphoma who satisfy eligibility requirements will be considered for admission to the trial.

"This is a very important and exciting trial to determine the efficacy and tolerability of a rationally designed and novel nanotechnology based drug delivery system of a cancer chemotherapeutic drug, with impressive preclinical activity in lymphoma," said lead investigator, Stephen Forman, M.D., Chair, Division of Hematology & Hematopoietic Cell Transplantation at City of Hope.

"We are very pleased to be working with Dr. Forman and City of Hope on this study," said James Hamilton, M.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Calando Pharmaceuticals. "This represents an excellent opportunity to leverage the IT-101 franchise into additional oncology indications, while minimizing clinical development costs."

IT-101, a drug conjugate conjugate /con·ju·gate/ (kon´jdbobr-gat)
1. paired, or equally coupled; working in unison.

2. a conjugate diameter of the pelvic inlet; used alone usually to denote the true conjugate diameter; see
 of camptothecin and Calando's proprietary cyclodextrin polymer nanoparticle, Cyclosert, has demonstrated a highly favorable toxicity profile and unique pharmacokinetic characteristics. Calando has recently completed enrollment of an ongoing phase I study of IT-101 at City of Hope for patients with non-resectable solid tumors and has filed with the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 to initiate a multi-site phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 of IT-101 in patients with ovarian cancer.

About Calando Pharmaceuticals Inc.

Calando Pharmaceuticals Inc. (www.calandopharma.com), a majority-owned subsidiary of Arrowhead Research Corporation (NASDAQ:ARWR), is a biopharmaceuticals company using proprietary technologies developed at Caltech to create targeted siRNA-based therapeutics and small molecule nanoparticle drug conjugates. Calando uses its innovative Cyclosert[TM] and RONDEL ron·del  
n.
1. A poem similar to a rondeau, having 13 or 14 lines with two rhymes throughout. The first and second lines reappear in the middle and at the end, although sometimes only the first line appears at the end.

2.
[TM] nanoparticle systems to solve the long-standing obstacle of effective delivery and targeting for oligonucleotide and small molecule therapeutics.

Calando's Cyclosert[TM] technology uses cyclodextrins as building blocks to create an entirely new class of biocompatible materials - linear cyclodextrin-containing polymers that are non-toxic and non-immunogenic at therapeutic doses. The Company leverages Cyclosert[TM] to design, develop and commercialize drug-delivery-enhanced small-molecule therapeutics. IT-101 is Calando's lead small molecule Cyclosert conjugate, which recently completed a phase I study in solid tumors at City of Hope.

Calando's RONDEL[TM] technology involves the use of cyclodextrin-containing polymers that form the foundation for its two-part siRNA delivery system. The first component is a linear, cyclodextrin-containing polycation that, when mixed with small interfering RNA Small interfering RNA (siRNA), sometimes known as short interfering RNA or silencing RNA, are a class of 20-25 nucleotide-long double-stranded RNA molecules that play a variety of roles in biology.  (siRNA), binds to the anionic an·i·on  
n.
A negatively charged ion, especially the ion that migrates to an anode in electrolysis.



[From Greek, neuter present participle of anienai, to go up : ana-, ana-
 "backbone" of the siRNA. The polymer and siRNA self-assemble into nanoparticles smaller than 100 nm in diameter that fully protect the siRNA from nuclease nuclease /nu·cle·ase/ (noo´kle-as) any of a group of enzymes that split nucleic acids into nucleotides and other products.

nu·cle·ase
n.
 degradation in serum. The siRNA delivery system has been designed to allow for intravenous injection. Upon delivery to the target cell, the targeting ligand binds to membrane receptors on the cell surface and the RNA-containing nanoparticle is taken into the cell by endocytosis endocytosis (ĕn'dōsītō`səs), in biology, process by which substances are taken into the cell. When the cell membrane comes into contact with a suitable food, a portion of the cell cytoplasm surges forward to meet and surround . There, chemistry built into the polymer functions to unpackage the siRNA from the delivery vehicle. Based upon this breakthrough in siRNA delivery enabled by the RONDEL[TM] system, the promise of using siRNA in new systemic therapies may finally be realized.

Forward-Looking Statements

This news release and any oral statements made with respect to the information contained in this news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on Calando's management current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include, among others: the risk that CALAA-01 or IT-101 may appear promising in early research and clinical trials but may not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risks that the regulatory approvals may not be obtained, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; competition; litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
; and risks associated with our ability to protect our intellectual property. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
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Date:Jun 12, 2008
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