Free Declaration in Support - District Court of California - California

Case 4:07-cv-04972-CW

Document 20-4

Filed 03/07/2008

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Exhibit C

Threshold Pharmaceuticals - News Release Case 4:07-cv-04972-CW Document 20-4

Filed 03/07/2008

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Threshold Pharmaceuticals Announces Positive Results From TH-070 Phase 2 Study in Treatment of Benign Prostatic Hyperplasia Trial Shows Significant Sustained Improvement in Symptoms Six Months Off Therapy
REDWOOD CITY, Calif., May 19 /PRNewswire/ -- Threshold Pharmaceuticals Inc. (Nasdaq: THLD - News) today announced follow up results of a Phase 2 study of its investigational drug candidate, TH-070 (lonidamine) for the treatment of benign prostatic hyperplasia (BPH). Six months after cessation of treatment, BPH symptoms (IPSS) in patients remained significantly improved compared to baseline as were maximum urine flow, post void urine volume, and PSA. The trial, conducted in 2004 at the University of Bari, Italy, met its primary endpoint, a mean reduction in prostate volume at day 28 compared to baseline (-11.2%, p<0.001), and all other Day 28 endpoints. Based on promising data from the initial dose group of patients in this study, Threshold elected not to enroll a second higher dose group and instead plans to initiate a Phase 2 multi-center study in the US and a Phase 3 multicenter study in Europe for TH-070 to treat symptomatic BPH in mid 2005.

In the reported trial, thirty patients with symptomatic BPH received TH-070 orally (150 mg) once daily for 28 days. The regimen was well tolerated, with no therapy-related adverse side effects. Highlights of the post study follow-up results six months later include:

-- Validated International Prostate Symptom Scores (IPSS) improved from a mean of 19.5 prior to treatment to 12.2 at Day 28 (p<0.001) with an additional improvement to 9.8 after six month follow-up. -- Mean Maximum Urine Flow improved 34.3% from a mean of 9.4 mL/sec at baseline to 12.6 mL/sec at day 28 (p=0.002) and improved 45.6% to a mean of 13.7 mL/sec at six month follow-up (p<0.001). -- PSA decreased on average by 17.8 percent from a mean of 3.6 at baseline to 2.8 ng/mL at Day 28 (p<0.001) and on average by 14.8% to a mean of 3.1 ng/mL at six month follow-up (p=0.012). -- Mean PVR (Post-void residual urine volume) decreased by 52.5 percent from a mean of 82.1 cc at baseline to 31.6 cc at Day 28 (p<0.001) and to 39.0 cc at six month follow-up (p=.003).

"The magnitude and rapidity of the patients' response to TH-070 are very encouraging in the pharmaceutical treatment of BPH," said George Tidmarsh, founder of Threshold Pharmaceuticals. "We are especially pleased to

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3/7/2008

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see that the effect of TH-070 is sustained off therapy."

Detailed results of the study will be published by MedReviews in the quarterly journal of Reviews in Urology available at the American Urology Association (AUA) annual meeting in San Antonio, Texas May 22 - 25, 2005. The information will be also be available May 18th online at the MedReviews website http://www.medreviews.com.

About the Phase 2 Study

Subjects were assessed at baseline, at active-therapy assessment visits (days 14, 28), and 1, 2, 3, and 6 months post-therapy. Assessments included prostate volume (PV) by transrectal ultrasound (TRUS), maximum flow rate (Qmax) on uroflowmetry, post-void residual urine volume (PVR), International Prostate Symptom Score (IPSS), prostate specific antigen (PSA) levels, serum chemistry, and adverse events. Previous treatment with 5-alphareductase inhibitors was not allowed and alpha-blockers were discontinued at least 14 days prior to study.

About TH-070 and prostate metabolism

TH-070, an indazole-3-carboxylic acid, is thought to disrupt energy metabolism by interfering with glycolysis. Glandular prostate epithelial cells -- cells that overgrow in BPH -- are unique in that they are dependent on glycolysis for energy production. Preclinical data and Phase 2 data thus far supports that TH-070 presents a potentially effective method for targeting these prostate cells and may provide rapid symptom improvement, decreased prostate size, increase in urine flow, decreased serum PSA, and limited side effects for the treatment of BPH.

About Benign Prostatic Hyperplasia (BPH)

BPH, also known as benign enlargement of the prostate, is the most common urological problem among older men and affects an estimated 17 million men in the United States, 27 million men in five major European countries and eight million men in Japan. BPH can restrict the flow of urine, resulting in urine retention, which can cause weakening of the bladder wall and the inability to empty the bladder completely. It can also be progressively severe, with a risk of urinary tract infection, kidney and bladder damage, bladder stones and incontinence. However, current drug and surgical therapies for BPH are not completely effective, often having slow onset and with side effects ranging from decreased libido, sexual dysfunction and reduced quality of life to cardiovascular effects and/or surgical complications.

About Threshold Pharmaceuticals

Threshold is a biotechnology company focused on the discovery, development and commercialization of small molecule therapeutics based on Metabolic Targeting, an approach that offers broad potential to treat most solid tumors and certain other diseases. By selectively targeting tumor cells, the company is building a pipeline of drug candidates that hold promise to be more effective and less toxic to healthy tissues than conventional drugs. Threshold's initial clinical focus is the treatment of cancer and benign prostatic hyperplasia, or BPH, a disease afflicting tens of millions of men worldwide. For additional information, please visit http://www.thresholdpharm.com.

NOTE: This press release contains forward-looking statements regarding Threshold's TH-070 product candidate and its potential therapeutic benefits for BPH. These statements involve risks and uncertainties that can cause

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actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to initiate, enroll and complete its anticipated clinical trials, the results of such clinical trials (including unanticipated product side-effects or safety issues), the time and expense required to conduct such clinical trials, the results of such clinical trials (including unanticipated product sideeffects), Threshold's ability to obtain regulatory approval for its product candidates based on such clinical trials and Threshold's ability to protect and enforce intellectual property rights regarding TH-070. Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Annual Report on Form 10-K/10-Q, which was filed with the Securities Exchange Commission on March 31, 2005/March 13, 2005 and is available from the SEC's website (www.sec.gov) and on our website (www.thresholdpharm.com) under the heading "Investors". We undertake no duty to update any forward-looking statement made in this news release.

http://investor.thresholdpharm.com/ReleaseDetail.cfm?ReleaseID=164643

3/7/2008